The main purpose of this study is to investigate the safety and efficacy of the study drug solanezumab in participants with prodromal Alzheimer's disease (AD).

Start Date01 Jun 2016

Sponsor / Collaborator

Eli Lilly & Co.

NCT02614131

/ TerminatedPhase 1

Single-Dose and Multiple-Dose, Dose-Escalation Study With LY2599666 to Evaluate the Safety, Pharmacokinetics, and Tolerability in Healthy Subjects and Patients With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild-to-Moderate Alzheimer's Disease

The main purpose of this study is to evaluate the safety and tolerability of the study drug known as LY2599666 in different groups of people - those who are healthy, those who have mild cognitive impairment due to Alzheimer's Disease (AD), and those with mild-to-moderate AD. The study will measure how much LY2599666 gets into the bloodstream and how long it takes the body to get rid of it. It will also evaluate how LY2599666 affects the body. The study has three parts. Part A will last about 2 months. Parts B and C will each last about 23 weeks. Participants may only enroll in one part.

Start Date01 Dec 2015

Sponsor / Collaborator

Eli Lilly & Co.

NCT02008357

/ CompletedPhase 3

Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)

The purpose of this study is to test whether an investigational drug called solanezumab can slow the progression of memory problems associated with brain amyloid (protein that forms plaques in the brains of people with Alzheimer Disease [AD]).

Start Date28 Feb 2014

Sponsor / Collaborator

Eli Lilly & Co.

100 Clinical Results associated with Solanezumab

100 Translational Medicine associated with Solanezumab

100 Patents (Medical) associated with Solanezumab

328

Literatures (Medical) associated with Solanezumab

07 Jul 2026·BRAIN

Early glymphatic failure in AppNL-F knock-in mice is linked to parenchymal border macrophages loss

Article

Author: Swanberg, Kelley M ; Lundgaard, Iben ; Deierborg, Tomas ; Syvänen, Stina ; Kritsilis, Marios ; Yang, Yiyi ; Liu, Na ; Liu, Chenchen ; Sehlin, Dag ; Liu, Xuanhui ; Nilsson, Per ; Moonen, Brecht

Abstract:

Amyloid-β (Aβ) accumulation is a hallmark of Alzheimer’s disease. Cerebral Aβ deposition is attenuated by a functional glymphatic system, in which perivascular entry of CSF and its exchange with interstitial fluid mediate solute clearance. Parenchymal border macrophages (PBMs), positioned along glymphatic pathways, are emerging as important players for glymphatic clearance. However, how glymphatic function and PBMs are affected in App knock-in models of Alzheimer’s disease is unknown.In this study, we used two App knock-in mouse models that develop progressive Aβ pathology, AppNL-F and AppNL-G-F. AppNL-F mice showed reductions in glymphatic influx and clearance at 6 months, preceding substantial Aβ plaque deposition. The decrease in glymphatic function in AppNL-F mice was correlated with a loss of PBMs and altered marker expression. Acute administration of Aβ into the CSF decreased the number of PBMs and impaired glymphatic transport in wild-type mice, thus recapitulating the pre-plaque stage. In contrast, the number of PBMs was not reduced in AppNL-G-F mice, possibly owing to an enhanced Aβ phagocytic capacity in PBMs. Four weeks of systemic anti-Aβ antibody treatment efficiently reduced Aβ plaque load and rescued PBMs in some brain regions; however, the treatment did not restore glymphatic function in the AppNL-F model.These findings suggest that glymphatic dysfunction in App knock-in models of Alzheimer’s disease is not driven by parenchymal Aβ plaque load but is closely linked to pre-plaque Aβ-induced loss of PBMs. Preservation of PBM abundance and their normal marker expression might be important for maintaining glymphatic function and mitigating early progression of Alzheimer’s disease.

01 Jul 2026·Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring

Relationships between longitudinal retinal amyloid imaging and amyloid PET in the A4 Trial

Article

Author: Belsha, Alison ; Rafii, Michael S. ; Ngolab, Jennifer ; Rissman, Robert A. ; Jaiswal, Sandhya ; Donohue, Michael C. ; Tan, Veasna ; Ramanan, Srinath ; Salloway, Stephen ; Salazar, Jennifer ; Lah, James J. ; Verdooner, Steven R. ; Sperling, Reisa A. ; Sukreet, Sonal ; Cohen, Paula ; van Dyck, Christopher H. ; Jicha, Gregory A. ; Alber, Jessica ; Johnson, Ken ; Aisen, Paul S. ; Aggarwal, Neelum T.

Abstract:

INTRODUCTION:

Alzheimer's disease (AD) is associated with retinal amyloid‐related changes, which may help identify amyloid positron emission tomography (PET) positive (+) individuals. Previously, in a small cross‐sectional study, we reported higher retinal spot counts (RSCs) in preclinical amyloid PET (+) individuals screened for the Anti‐Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4) trial compared to control individuals enrolled in the Longitudinal Evaluation of Amyloid Risk and Neurodegeneration (LEARN) trial before drug treatment.

METHODS:

Eligible volunteers had retinal scans 48 hours after consuming curcumin. Scans were processed and quantified via NeuroVision. Participants were grouped by amyloid status and treatment to assess the effect of solanezumab on RSC.

RESULTS:

RSC did not differ significantly over time between groups and was not modified by treatment, diverging from the cross‐sectional retinal amyloid findings observed in A4/LEARN.

DISCUSSION:

Curcumin‐based retinal amyloid labeling shows promise but needs standardized protocols and validation in larger cohorts to understand its relationship to amyloid PET.

01 Jun 2026·JOURNAL OF ALZHEIMERS DISEASE

Dementia screening with the Rivermead Behavioural Memory Test: A machine learning analysis

Article

Author: Fujiwara, Yu ; Kanazawa, Tetsufumi ; Kitano, Masato ; Maruyama, Soichiro ; Toyoda, Katsutaka ; Toda, Hiroyuki

Background:

With the advent of anti-amyloid-β monoclonal antibody therapies and the growing societal burden of dementia, early identification of Alzheimer's disease and related dementias has become a clinical priority.

Objective:

To evaluate the diagnostic accuracy of a machine learning model using a neuropsychological battery to classify individuals as Healthy controls, mild cognitive impairment (MCI), or Dementia, and to identify neuropsychological tests and cognitive domains that contributed most to classification accuracy, determining optimal tests for dementia screening.

Methods:

In this retrospective cross-sectional single-center study, we analyzed 590 participants evaluated for suspected dementia. The final sample comprised 74 Healthy controls, 190 individuals with MCI, and 326 with Dementia (including 269 with Alzheimer's disease). Scores from the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment Japanese version (MoCA-J), Rivermead Behavioural Memory Test (RBMT), Japanese Adult Reading Test (JART), and Wechsler Adult Intelligence Scale-III were input into a random forest machine learning model. Model performance was assessed using the area under the ROC curve (AUC). A variable importance analysis determined each test's relative contribution to classification.

Results:

The multiclass model achieved an AUC of 0.898. RBMT was the strongest contributor, exceeding MMSE and MoCA-J. In borderline MMSE/MoCA-J subsets, adding RBMT improved classification performance for both Healthy versus MCI and MCI versus Dementia decisions.

Conclusions:

RBMT provides substantial incremental value for dementia-related diagnostic discrimination, particularly as a second-line assessment when brief screening results are borderline. However, its administration time may limit its role as a universal first-line screening tool.

News (Medical) associated with Solanezumab

06 Aug 2026

·www.prnewswire.com

The Next Billion-Dollar Opportunity in Alzheimer's Disease Market: 6 Pipeline Therapies to Watch | DelveInsight

The Alzheimer's disease market dynamics are anticipated to change due to the expected launch of emerging therapies, such as Masupirdinea (Suven Life Sciences), Trontinemabb (Roche), Buntanetap (Annovis bio), Masitinib (AB Science), Remternetug (Eli Lilly), AUVELITY (AXS-05) (Axsome Therapeutics), Bezisterim (NE3107) (Biovie), Valiltramiprosate (ALZ-801) (ALZHEON), Hydromethylthionine mesylate (HMTM) (TRx0237) (TauRx Therapeutics), COBENFY (KarxXT) (Bristol Myers Squibb), AR1001d (AriBio), Remlifanserin (ACP ‑ 204) (Acadia Pharmaceuticals), Tricaprilin (Cerecin), and others, and others. LAS VEGAS, Aug. 6, 2026 /PRNewswire/ -- The Alzheimer's disease treatment landscape is experiencing a major transformation with the introduction of disease-modifying therapies that target fundamental disease mechanisms, particularly amyloid-β pathology. Among these, LEQEMBI (lecanemab) has become a leading biologic for patients with early-stage Alzheimer's disease, demonstrating its ability to slow cognitive and functional deterioration in biomarker-confirmed individuals. Regulatory approvals across key global markets have strengthened the shift toward earlier diagnosis, timely intervention, and biologically targeted treatment approaches. Furthermore, the approval of LEQEMBI IQLIK, a subcutaneous maintenance formulation, is anticipated to enhance patient convenience by allowing at-home or simplified administration, reducing reliance on infusion-based therapy. Likewise, KISUNLA (donanemab) has emerged as another important anti-amyloid monoclonal antibody, offering clinically meaningful reductions in disease progression while distinguishing itself through the potential to discontinue treatment after achieving amyloid plaque clearance. Discover more about the Alzheimer's disease therapeutics market @ While disease-modifying biologics are reshaping therapeutic strategies, symptomatic treatments remain integral to the clinical management of Alzheimer's disease. ZUNVEYL (benzgalantamine), a next-generation oral acetylcholinesterase inhibitor (AChEI), has been developed to improve gastrointestinal tolerability and long-term treatment adherence. Similarly, ALLYDONE transdermal donepezil patches provide an alternative drug delivery option designed to improve compliance, particularly among elderly patients. In addition, REXULTI (brexpiprazole) has broadened the treatment landscape by addressing agitation associated with Alzheimer's disease dementia, reflecting the growing emphasis on managing both cognitive impairment and neuropsychiatric symptoms. Collectively, the combination of disease-modifying monoclonal antibodies with enhanced symptomatic and behavioral therapies is expected to redefine Alzheimer's disease management by promoting earlier intervention, personalized care, and a more comprehensive treatment approach. Sadaf Javed, Functional Head of Forecasting & Analytics at DelveInsight, said there is an opportunity for companies to conduct trials evaluating safer therapies with convenient patient doses at low cost that can enhance treatment compliance and adherence. Beyond currently available therapies, the late-stage Alzheimer's disease pipeline continues to diversify, with multiple investigational candidates employing mechanisms that extend beyond conventional amyloid-focused strategies, highlighting the field's evolving emphasis on targeting complementary pathological pathways. Key candidates include Masupirdinea (Suven Life Sciences), Trontinemabb (Roche), Buntanetap (Annovis bio), Masitinib (AB Science), Remternetug (Eli Lilly), AUVELITY (AXS-05) (Axsome Therapeutics), Bezisterim (NE3107) (Biovie), Valiltramiprosate (ALZ-801) (ALZHEON), Hydromethylthionine mesylate (HMTM) (TRx0237) (TauRx Therapeutics), COBENFY (KarxXT) (Bristol Myers Squibb), AR1001d (AriBio), Remlifanserin (ACP ‑ 204) (Acadia Pharmaceuticals), Tricaprilin (Cerecin), and others. Reflecting sustained innovation and expanding commercial opportunities, DelveInsight estimates that the Alzheimer's disease market across the seven major markets, comprising the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan, was valued at approximately USD 4 billion in 2025. The market is projected to expand at a CAGR of 22.7% during the forecast period through 2036, driven by increasing disease prevalence, broader adoption of disease-modifying therapies, advancements in biomarker-based diagnosis, and a robust late-stage pipeline focused on improving clinical outcomes. Below, we highlight 6 emerging late-stage therapies poised to enter the Alzheimer's disease therapeutics market. Suven Life Sciences' Masupirdine 5-HT6 antagonist Masupirdine (SUVN-502) is an investigational small-molecule candidate from Suven Life Sciences that is being developed to treat cognitive impairment and neuropsychiatric manifestations, particularly agitation, in patients with Alzheimer's disease. As a highly selective serotonin 5-HT6 receptor antagonist, Masupirdine is designed to enhance the release of neurotransmitters involved in cognition and behavioral regulation, to improve cognitive performance as well as neuropsychiatric symptoms. In contrast to conventional treatment approaches that may be associated with sedation, Masupirdine is intended to offer a non-sedating therapeutic option by selectively modulating central serotonergic pathways. The therapy is being investigated to address significant unmet needs in Alzheimer's disease, especially for agitation and aggression, where effective and well-tolerated treatment options remain limited. Masupirdine is currently being assessed in a global Phase III clinical trial evaluating its efficacy in treating agitation associated with Alzheimer's disease dementia. The study is expected to conclude by the end of 2026, with topline results anticipated during the first half of 2027. In June 2026, Suven Life Sciences announced encouraging results from a pre-specified interim analysis and an independent review by the Data and Safety Monitoring Board (DSMB), supporting the continuation of the Phase III development program. According to Javed, Masupirdine has demonstrated a favorable safety and tolerability profile, reinforcing its potential as a therapeutic candidate. However, its ultimate success will depend on optimized clinical trial execution and appropriate patient selection. While the therapy holds considerable promise, additional clinical validation will be essential to confirm its efficacy and support future regulatory approval. Roche's Trontinemab Aβ-protein Inhibitors Trontinemab (RG6102) is an investigational bispecific monoclonal antibody engineered with Brainshuttle technology to enhance the delivery of anti-amyloid therapies across the blood–brain barrier for the treatment of Alzheimer's disease. It selectively binds aggregated amyloid-beta (Aβ) and is designed to promote rapid and robust clearance of amyloid plaques from the brain. The therapy integrates an anti-Aβ antibody with Roche's proprietary Transferrin Receptor 1 (TfR1)-mediated Brainshuttle platform, which improves transport into the central nervous system. By increasing brain exposure at lower doses than conventional anti-amyloid antibodies, trontinemab has the potential to accelerate and enhance amyloid plaque removal. This improved brain penetration may amplify the disease-modifying effects of amyloid-targeting therapies and help slow the progression of Alzheimer's disease. According to Roche, regulatory filings for trontinemab are currently expected after 2028. Explore more about recent advancements in Alzheimer's disease-modifying treatments @ Timeline of Alzheimer's Disease Treatment Axsome Therapeutics' AXS-05 NMDA receptor Antagonist AXS-05 is an investigational oral therapy engineered with a multimodal mechanism of action to address disorders of the central nervous system (CNS). It combines dextromethorphan and bupropion in a proprietary formulation that is designed to optimize the pharmacological activity of dextromethorphan. As part of its mechanism, dextromethorphan acts as both an N-methyl-D-aspartate (NMDA) receptor antagonist and a sigma-1 receptor agonist, helping regulate glutamatergic signaling and neuronal communication implicated in CNS disorders. The NMDA receptor is essential for synaptic function, learning, memory, and neuronal plasticity, and abnormalities in this pathway have been linked to a range of neurodegenerative and neuropsychiatric conditions. By modulating these signaling pathways, AXS-05 represents a promising therapeutic approach for disorders associated with cognitive dysfunction and behavioral disturbances. The therapy is currently under clinical investigation for several indications, including agitation related to Alzheimer's disease and smoking cessation. While these uses have not yet been approved by the U.S. FDA, AXS-05 has received Breakthrough Therapy Designation for the treatment of agitation associated with Alzheimer's disease. This designation highlights its potential to address a substantial unmet medical need by improving the management of neuropsychiatric symptoms in individuals living with Alzheimer's disease. Bristol Myers Squibb's COBENFY Muscarinic M1/M4 receptor agonist COBENFY (KarXT; xanomeline–trospium chloride) is a novel muscarinic receptor-targeting therapy under investigation for the treatment of Alzheimer's disease psychosis (ADP). In contrast to traditional antipsychotics, which primarily exert their effects through dopamine receptor antagonism, COBENFY selectively stimulates M1 and M4 muscarinic acetylcholine receptors within the central nervous system. This differentiated mechanism aims to alleviate both psychotic and cognitive symptoms associated with Alzheimer's disease while potentially reducing the risk of adverse effects commonly linked to dopamine-blocking therapies. Administered orally, COBENFY represents an innovative therapeutic strategy within the evolving Alzheimer's disease treatment landscape. COBENFY is currently advancing through Phase III clinical development for Alzheimer's disease psychosis, with topline results anticipated in 2026. Beyond psychosis, the therapy is also being evaluated for additional Alzheimer's disease-related conditions, including agitation and cognitive impairment, highlighting its potential as a broad-spectrum neuropsychiatric treatment. The ongoing ADEPT-1, ADEPT-2, and ADEPT-4 Phase III studies are expected to deliver topline results for Alzheimer's disease psychosis in 2026. If these studies are successful and regulatory approvals are secured, COBENFY could reach the market as early as 2027. In Alzheimer's disease agitation, the Phase III ADAGIO-2 trial is projected to report results in 2028, which could support a commercial launch beginning in 2029. Additionally, the MINDSET-1 and MINDSET-2 trials are assessing the therapy's impact on cognitive impairment associated with Alzheimer's disease. These studies are also expected to report findings in 2028, with commercialization potentially commencing in 2029, subject to favorable clinical outcomes and regulatory clearance. According to Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight, COBENFY (KarXT) introduces a differentiated, non-dopaminergic approach to managing neuropsychiatric manifestations of Alzheimer's disease by selectively targeting central M1 and M4 muscarinic receptors. This mechanism may overcome some of the safety challenges associated with conventional antipsychotic therapies. Its comprehensive Phase III clinical program spanning psychosis, agitation, and cognitive impairment underscores the company's strategy to establish COBENFY as a versatile, multi-indication treatment for neuropsychiatric complications in Alzheimer's disease. To know more about Alzheimer's disease drug development, visit @ Alzheimer's Disease Treatment Pipeline Eli Lilly's Remternetug Aβ-protein Inhibitors Remternetug (LY3372993) is an investigational monoclonal antibody being developed for the treatment of early-stage Alzheimer's disease. It is formulated for both intravenous (IV) and subcutaneous (SC) administration and selectively targets N3pG amyloid-beta (Aβ), a modified amyloid species implicated in the disease's pathology. By binding to toxic amyloid plaques in the brain, the therapy promotes their clearance through immune-mediated mechanisms to slow disease progression. Remternetug has completed Phase I clinical studies and is currently undergoing Phase III clinical evaluation in patients with early Alzheimer's disease. Thakur noted that remternetug underscores Eli Lilly's focus on advancing next-generation amyloid-targeting antibodies designed to improve patient convenience, particularly by enabling potential subcutaneous delivery and faster amyloid plaque clearance. Annovis Bio's Buntanetap Translational Inhibitor of Neurotoxic Aggregating Proteins (TINAPs) Buntanetap (previously known as ANVS401 or Posiphen) is an orally available small-molecule therapy developed using a proprietary synthetic biochemical process. It represents a first-in-class group of therapeutics called Translational Inhibitors of Neurotoxic Aggregating Proteins (TINAPs), which are designed to suppress the production of multiple neurotoxic proteins involved in the progression of neurodegenerative diseases. By targeting several pathogenic proteins simultaneously, Buntanetap offers a differentiated mechanism of action with the potential to address the underlying pathology of these disorders. The therapy is being evaluated across a range of neurodegenerative indications, including Alzheimer's disease, Parkinson's disease, and Alzheimer's disease associated with Down syndrome. Buntanetap has completed a Phase II/III clinical trial in patients with mild-to-moderate Alzheimer's disease and is currently being assessed in a Phase III trial for individuals with early Alzheimer's disease, highlighting its potential to deliver therapeutic benefits across different stages of disease progression. Download the report to understand the top emerging therapies in Alzheimer's Disease @ Alzheimer's Disease Drug Development Pipeline Source: Alzheimer's Disease Market Report Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Alzheimer's disease companies, including ARS Pharmaceuticals, Alfresa Pharma, Roche, Stallergenes Greer, DBV Technologies, Aquestive Therapeutics, Aravax, Siolta Therapeutics, GSK, Cue Biopharma, N-Fold, InnoUp Farma, Allergy Therapeutics, UKKO, Bryn Pharma, Poplar Therapeutics, Inimmune, Novartis (Excellergy), Intrommune Therapeutics, Regeneron Pharmaceuticals, Sanofi, Moonlight Therapeutics, Mabylon AG, Insignis Therapeutics, ALK-Abello, Cambridge Allergy, Prota Therapeutics, and others. Related Reports Alzheimer's Disease Clinical Trial Analysis Alzheimer's Disease Pipeline Insight – 2026 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key Alzheimer's disease companies, including Anavex Life Sciences Corp., TauRx Therapeutics Ltd, BioVie Inc., AriBio Co., Ltd., Novo Nordisk A/S, AgeneBio, Neurim Pharmaceuticals, Eisai Inc., T3D Therapeutics, Merck Sharp & Dohme, Shanghai Hengrui Pharmaceutical, NeuroSense Therapeutics, Pharmazz, Johnson & Johnson Innovative Medicine, NKGen Biotech, LEXEO Therapeutics, Inventage Lab, Neumora Therapeutics, Takeda, Perha Pharmaceuticals, Luye Pharma Group Ltd., Eli Lilly and Company, Prothena, Therabest Korea, Neurotez, TRIMTECH Therapeutics, Lexeo Therapeutics, and others. Agitation in Alzheimer's Disease Market Agitation in Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key agitation in Alzheimer's disease companies, including IGC Pharma, Suven Life Sciences, Exciva GmbH, Bristol Myers Squibb, Karuna Therapeutics, Otsuka Pharmaceutical, Lundbeck, Axsome Therapeutics, and others. Dementia-related Psychosis Market Dementia-related Psychosis Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key dementia-related psychosis companies, including Acadia Pharmaceuticals, Bristol Myers Squibb, Cognition Therapeutics, Maplight Therapeutics, Johnson & Johnson, AgeneBio, and others. Psychosis in Parkinson's and Alzheimer's Disease Market Psychosis in Parkinson's and Alzheimer's Disease Market Insights, Epidemiology, and Market Forecast – 2036 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key psychosis in Parkinson's and Alzheimer's disease companies, including Sunovion Pharmaceuticals, Karuna Therapeutics, Vanda Pharmaceuticals, Suven Life Sciences, Enterin, Intra-Cellular Therapies, Merck Sharp & Dohme, and others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 SOURCE DelveInsight Business Research, LLP 21% more press release views with Request a Demo

Phase 3Drug ApprovalBreakthrough TherapyPhase 2

16 Apr 2026

·www.fiercepharma.com

'Absent or trivial' effects: Anti-amyloid Alzheimer's drugs called into question once again

Removing amyloid beta plaques in the brain has been a leading treatment approach in Alzheimer's disease for many years, but it's failing to move the needle even after many attempts, a group of researchers contends. Top drugmakers have spent more than a decade investigating and advancing anti-amyloid Alzheimer's medicines in clinical studies, generating enough evidence to support FDA approvals for three of them so far. But a new analysis throws more cold water on the treatment approach after years of doubts—and some successes.Medicines in this class, which include Biogen and Eisai's Leqembi and Eli Lilly's Kisunla, "likely have no clinically meaningful positive effects," according to a press release from the nonprofit health research organization Cochrane. Further, the meds likely increase the risk of brain swelling, the group's review found.To reach this conclusion, the team compiled results from 17 studies assessing seven different amyloid‐beta‐targeting monoclonal antibodies, including the failed Aduhelm, Leqembi, Kisunla and several medicines that failed to reach the market. The studies, which all used placebo control cohorts, altogether enrolled more than 20,000 people.Overall, the results showed the drugs "probably result in little to no difference" on measures of cognitive function and functional ability, the team said. On dementia severity, the drugs "may result in little to no difference," according to the assessment."The effect of amyloid‐beta‐targeting monoclonal antibodies on cognitive function and dementia severity at 18 months in people with mild cognitive impairment or mild dementia due to Alzheimer’s disease is trivial, while on functional ability, it is small at best," the researchers concluded."Successful removal of amyloid from the brain does not seem to be associated with clinically meaningful effects in people with mild cognitive impairment or mild dementia due to Alzheimer’s disease," the team added. "Future research on disease‐modifying treatments for Alzheimer’s disease should focus on other mechanisms of action."Besides Aduhelm, Leqembi and Kisunla, the Cochrane team looked at the clinical track record for bapineuzumab, crenezumab, gantenerumab and solanezumab. Each of those drugs saw high-profile trial setbacks over the years.It's important to note that while the group has had its share of clinical blemishes, Leqembi did show a statistically significant reduction in clinical decline in a placebo-controlled trial, enabling the FDA to convert its initial FDA nod into a full approval. Likewise, Kisunla boasts a full approval and proved its worth by demonstrating a statistically significant reduction in clinical decline in its own placebo-controlled study.A spokesperson for Eli Lilly said the review is "built on an inherently flawed methodology.""It pools data from across multiple amyloid-targeting therapies as a class, including molecules that did not achieve their clinical trial endpoints and were never granted regulatory approval," Lilly's spokesperson added. "Combining data on unsuccessful molecules with approved medicines artificially dilutes the observed benefit and produces class-level conclusions that do not reflect the evidence for any individual approved therapy."On the subject of safety, the amyloid-targeting drugs "probably result in a small increase in the occurrence of any ARIA E," the shorthand for amyloid-related imaging abnormalities-edema, or brain swelling or fluid that's visible on an MRI. The meds aren't associated with any significant difference in symptomatic ARIA E, the analysis found.As for ARIA H, or brain bleeding, three studies assessing the side effect showed divergent results, which prevented a pooled analysis, the team noted. Researchers have been studying amyloid beta plaques and their potential ramifications for patients with Alzheimer's disease for decades. Within biopharma, treating the disease by targeting these plaques has yielded several high-profile drug candidates—with most failing to make the grade in the clinic. In 2022, it was revealed that a vast amount of research in the field appeared to contain fabricated materials, adding to doubts about anti-amyloid treatments and calls for drugmakers to look elsewhere in the quest for future Alzheimer's drugs.

Clinical Result

16 Apr 2026

·endpoints.news

Cochrane review dismissing amyloid drugs draws immediate backlash

A new report trying to settle a decades-old debate about Alzheimer’s disease has reached a dramatic conclusion: Antibody drugs that target sticky amyloid beta proteins in the brain simply don’t work. The meta-analysis, which compiles data from more than 20,000 patients across 17 clinical trials, determined that treatment with amyloid antibodies resulted in “little to no difference” in cognitive function, dementia severity and functional ability. The authors concluded that future Alzheimer’s drugs “should focus on other mechanisms of action.” But the study is filled with limitations sure to send many neuroscientists who have devoted their lives to these drugs into a tizzy. It overlooks the strongest arguments about why so many older attempts have failed; it ignores recent technological breakthroughs in delivering these kinds of drugs into the brain more efficiently; and it skirts over bigger and longer clinical trials that are still ongoing but promise to provide the most conclusive evidence on amyloid drugs yet. “I don’t think this changes the overall view of these therapies,” Eric McDade, a neurologist who studies these drugs and others at the WashU Medicine Memory Diagnostic Center in St. Louis, told Endpoints News . When asked if the meta-analysis would move the needle on the broader debate about the amyloid hypothesis, he said he “highly doubts it.” The study , published in the Cochrane Database of Systematic Reviews on Wednesday night, quickly spurred numerous headlines proclaiming the amyloid drugs useless or suggesting that the study will further fuel the ongoing debate about whether the marginal benefits of the medicines outweigh their risks, which can include brain bleeding and swelling. But several researchers contacted by Endpoints News were quick to point out what they see as a major methodological flaw. Only two clinical trials included in the review centered on the two amyloid antibodies that are commercially available in the US: Leqembi, sold by Biogen and Eisai; and Kisunla, made by Eli Lilly. Twelve clinical trials in the meta-analysis focused on drugs that failed their pivotal trials, including Genentech’s crenezumab, Johnson & Johnson’s bapineuzumab, Lilly’s solanezumab and Roche’s gantenerumab. Another three studies focused on Aduhelm, the controversial Biogen drug that the FDA approved against the will of its scientific advisors because it failed one of its two pivotal studies. The drug was subsequently withdrawn from the market after abysmal sales. “It should be no surprise that if you average 15 studies for drugs that don’t work with two studies for drugs that do work, that the average result shows that, as a class, these drugs don’t work,” Andrew Budson, associate director of the Boston University Alzheimer’s Disease Research Center, told Endpoints. “I just don’t think that this review is relevant for people living with Alzheimer’s disease.” For decades, much of the Alzheimer’s field has centered on the problematic protein known as amyloid beta. Scientists now know that the protein begins accumulating in our brains a decade or two before the first signs of memory loss set in. By that point, amyloid has formed plaques in the brain that trigger a cascade of other problems, including toxic tangles of a protein called tau and rampant inflammation. At least, that’s the gist of what scientists who adhere to the amyloid hypothesis of Alzheimer’s believe is happening. It’s an interpretation backed by reams of laboratory data and tantalizing genetic clues. Yet despite the billions of dollars that drugmakers have spent trying to clear out amyloid, they’ve barely made a dent in the disease. The dispute over whether amyloid has led the field astray — or worse, hijacked and blocked out promising alternative theories — has been roiling for years. Neuroscientists who are sticking to their guns often note that the earliest studies of amyloid-targeting drugs were tested in people already in the throes of dementia. In retrospect, scientists say those treatments were too little too late. There’s a variety of other arguments for why earlier attempts to target amyloid have failed. Some studies were done in people who had memory loss but turned out to not have amyloid plaques in the brain. Today, many companies use imaging molecules to make sure the patients they enroll in their studies actually have brains full of the plaques they are trying to remove. The type of amyloid that the drug targets may be important too. Older drugs like Lilly’s solanezumab that targeted free-floating forms of the protein failed to show a benefit in clinical studies. The commercialized drugs targeting smaller clumps of the protein, like Leqembi, or specific forms of the plaques, like Kisunla, showed modest but statistically significant slowing of cognitive decline. An Eisai spokesperson told Endpoints that the Cochrane review was “scientifically deeply flawed by inappropriately combining ineffective antibodies and failed studies with effective, regulatory-approved anti-amyloid treatments.” A Lilly spokesperson echoed that sentiment and said that pooling failed drugs with approved ones “dilutes the observed benefit and produces class-level conclusions that do not reflect the evidence for any individual approved therapy.” But combining data from disparate drugs may have had an unintended effect: making the medicines look safer than they really are. The risks of brain bleeding and swelling have only become prominent with the FDA-approved medicines. The Cochrane review concluded that there was probably “little to no difference” in symptomatic brain bleeding and swelling, risks that have been at the heart of the debate about whether the modest benefits of the drugs are worth it. McDade said that pooling all these studies together “underestimates the risk and benefit” of the two commercialized medicines, which “have the most consistent clinical benefit, which was modest and has been recognized as modest.” The Cochrane review authors, based at the Institute of Neurological Sciences of Bologna in Italy, did not immediately respond to questions from Endpoints. Whether the amyloid hypothesis proves to be the right one, drugmakers are marching down that road as ardently as ever. The trials included in the Cochrane review focused on people with mild cognitive impairment or in the early stages of dementia. Eisai and Lilly believe that their drugs will work better when given even earlier. Both companies are conducting large and lengthy clinical trials in seemingly healthy people who have evidence of amyloid accumulation, but no outward signs of memory loss. They hope that treating these so-called asymptomatic patients will more dramatically slow the disease. Results could come in the next couple of years. Other companies, including Roche, are working on next-generation versions of amyloid antibodies designed to better cross the protective blood-brain barrier — something that the existing medicines do rather poorly. Early results from Roche’s drug suggest greater and faster amyloid plaque reduction with far lower rates of brain bleeding and swelling. Several big pharma companies, including AbbVie, Bristol Myers Squibb and Novartis, have begun their own work on similar brain-targeting amyloid antibodies. Dozens of smaller companies have jumped on the trend as well. Marc Diamond, founding director of the Center for Alzheimer’s and Neurodegenerative Diseases at UT Southwestern Medical Center, doesn’t think the Cochrane review’s conclusions have any bearing on these new kinds of studies that are rejuvenating the often-dreary field. And although it’s too soon to know whether they will find success where so many others have failed, he is hopeful. “Stay tuned,” he said. “It is likely they will have a bigger effect.” Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.

Clinical Study

100 Deals associated with Solanezumab

External Link

KEGG	Wiki	ATC	Drug Bank
D10058	Solanezumab	-	DB11756

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Amnesia	Phase 3	United States	Eli Lilly & Co.	28 Feb 2014
Amnesia	Phase 3	Japan	Eli Lilly & Co.	28 Feb 2014
Amnesia	Phase 3	Australia	Eli Lilly & Co.	28 Feb 2014
Amnesia	Phase 3	Canada	Eli Lilly & Co.	28 Feb 2014
Cognition Disorders	Phase 3	United States	Eli Lilly & Co.	28 Feb 2014
Cognition Disorders	Phase 3	Japan	Eli Lilly & Co.	28 Feb 2014
Cognition Disorders	Phase 3	Australia	Eli Lilly & Co.	28 Feb 2014
Cognition Disorders	Phase 3	Canada	Eli Lilly & Co.	28 Feb 2014
Alzheimer Disease	Phase 3	United States	Eli Lilly & Co.	01 May 2009
Alzheimer Disease	Phase 3	Japan	Eli Lilly & Co.	01 May 2009

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02008357 (A4, Pubmed \| Alzheimers Dement)	Phase 3	Alzheimer Disease apologipoprotein E (APOE) ε4 \| plasma pTau217 \| amyloid positron emission tomography (PET) ... View more	216	Solanezumab	yskajirutn(kyvbuuaczt) = ydsqcklynx uedhcbyxda (mhbaufdtgj ) View more	Positive	01 Sep 2025
NCT04623242 (Pubmed)	Phase 2/3	Alzheimer Disease	-	Solanezumab	siiztomecs(rvbftlyxfv) = qyoaxvscme qcahsvlika (swalhqwmew, 0.43)	-	29 Apr 2024
NCT02008357 (A4, CTgov)	Phase 3	Alzheimer Disease \| Amnesia \| Cognition Disorders	1,169	Solanezumab (Solanezumab)	ahprkeuaug(fvzhbdsbqg) = vivgjudpme utqlfxcyiq (ydrduaorkx, 0.21) View more	-	28 Dec 2023
				placebo (Placebo)	ahprkeuaug(fvzhbdsbqg) = dgfzkwersi utqlfxcyiq (ydrduaorkx, 0.16) View more
NCT02008357 (A4, CTAD2023)	Phase 3	Alzheimer Disease A4	383	Solanezumab	azrsiouicw(bsgwnlbwin) = hildfmjdyi jqrstnnaek (kffcfnrqod, 0.14) View more	Positive	24 Oct 2023
NCT02008357 (A4, CTAD2023)	Phase 3	Alzheimer Disease	1,169	Solanezumab	zpudeyzpty(tvqkaldllf) = dzqxfbyvzl tzfatthcbl (exitxgrnio ) View more	Positive	24 Oct 2023
NCT02008357 (A4, Pubmed \| N Engl J Med)	Phase 3	Alzheimer Disease	1,169	Solanezumab	gqhayavasb(cyxbbhlmnb) = hxxrzdnxnk ogmruywadm (lexvsbkoqj )	Negative	21 Sep 2023
				Placebo	gqhayavasb(cyxbbhlmnb) = mtlxsknhgd ogmruywadm (lexvsbkoqj )
NCT02760602 (ExpeditionPRO, CTgov)	Phase 3	Alzheimer Disease	26	Solanezumab (Solanezumab)	rwbxvxmqyj(pcpunraign) = aetjxamqkg qacwoqskjs (zfvyaeeick, ghyrtwykhb - nrycdirbas) View more	-	24 Jul 2018
				Placebo (Placebo)	rwbxvxmqyj(pcpunraign) = wjxpjqeduw qacwoqskjs (zfvyaeeick, bmmyimdacd - yfypvhdzsj) View more
NCT01127633 (EXPEDITION EXT, CTgov)	Phase 3	Alzheimer Disease	1,457	Placebo (Placebo)	zlxltjramn = ezcyucmrjk aaqovxuvec (fcoxzglfca, jatdnqkbki - qpiaurnmlw) View more	-	03 May 2018
				Solanezumab (Solanezumab)	zlxltjramn = xrzvmbkxac aaqovxuvec (fcoxzglfca, ipzsctudyq - cogluvvqxf) View more
NCT01900665 (EXPEDITION3 \| EXPEDITION 3, CTgov)	Phase 3	Alzheimer Disease	2,129	Solanezumab (Solanezumab)	zgynhehvic(qxxadyxfgu) = lqertcyolr keptbtgnao (ckcyegoshy, 0.355) View more	-	14 Mar 2018
				Placebo (Placebo)	zgynhehvic(qxxadyxfgu) = xtgvowfvah keptbtgnao (ckcyegoshy, 0.356) View more
NCT01900665 (EXPEDITION3, Pubmed \| Br Dent J \| N Engl J Med) Manual	Phase 3	Alzheimer Disease \| Dementia	2,129	Solanezumab	mtlpggeyil(nzqxbzqqqd) = lcoqueqxmr plsxkjgiyz (jalwjsauhg ) View more	Negative	25 Jan 2018
				Placebo	mtlpggeyil(nzqxbzqqqd) = jkdlcpbjbm plsxkjgiyz (jalwjsauhg ) View more

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