A Single- and Multiple-Ascending Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LY3954068 in Patients With Early Symptomatic Alzheimer's Disease

The main purpose of this study is to evaluate the safety of LY3954068 in participants with early symptomatic Alzheimer's Disease (AD). The study will also investigate how much LY3954068 gets into the bloodstream and will test the effects of LY3954068 on markers of AD.
The study will be comprised of two parts, A and B. Part B is optional, and participants from Part A may also have the opportunity to join an optional bridging period to a separate potential study where participants would receive LY3954068. Each enrolled participant in Part A will receive a single dose of LY3954068 or placebo (no active drug) given into the spinal fluid. If conducted, each participant in Part B would receive 2 doses of either LY3954068 or placebo administered into the spinal fluid.
The study will last up to approximately 45 weeks for Part A, and, if conducted, 73 weeks for Part B, including the screening period.
If the optional bridging period is conducted, participants in Part A could be enrolled in the separate potential study for up to approximately 96 weeks, including the screening period.

Start Date15 Aug 2024

Sponsor / Collaborator

Eli Lilly & Co.

NCT05617014

/ RecruitingNot ApplicableIIT

Alzheimer's Disease Neuroimaging Initiative 4 (ADNI4)

Since its launch in 2004, the overarching aim of the Alzheimer's Disease Neuroimaging Initiative (ADNI) Study has been to validate biomarkers for Alzheimer's disease (AD) clinical trials. ADNI4 continues the previously funded ADNI1, ADNI-GO, ADNI2, and ADNI3 studies that have combined public/private collaborations between academia and industry to determine the relationships between the clinical, cognitive, imaging, genetic and biochemical biomarker characteristics of the entire spectrum of AD.

Start Date09 Jun 2023

Sponsor / Collaborator

University of Southern California

[+2]

100 Clinical Results associated with Flortaucipir F-18

100 Translational Medicine associated with Flortaucipir F-18

100 Patents (Medical) associated with Flortaucipir F-18

316

Literatures (Medical) associated with Flortaucipir F-18

01 Mar 2025·NUCLEAR MEDICINE AND BIOLOGY

Transmembrane protein 106B amyloid is a potential off-target molecule of tau PET tracers in the choroid plexus

Article

Author: Furumoto, Shozo ; Kudo, Yukitsuka ; Iwata, Ren ; Okamura, Nobuyuki ; Kudo, Kaede ; Yokoyama, Yuka ; Harada, Ryuichi

PURPOSE:

Tau positron emission tomography (PET) has become an essential tool for the clinical diagnosis of neurodegenerative diseases and the study of tau pathology in the brain. However, some tau tracers exhibit off-target binding in the basal ganglia, choroid plexus, and meninges. Recently, transmembrane protein 106B (TMEM106B) was identified to form novel amyloid filaments in the brain during aging. In this study, we explored the possibility that TMEM106B aggregates might be responsible for off-target binding of tau PET tracers in the choroid plexus.

METHODS:

The binding properties of ¹⁸F-labeled tau and amyloid tracers against choroid plexus tissues from postmortem human brains were evaluated through in vitro autoradiography and in vitro binding assays and compared with histochemical staining.

RESULTS:

Autoradiography showed strong binding of [¹⁸F]PM-PBB3 followed by [¹⁸F]flortaucipir in the choroid plexus. Immunostaining of the same sections revealed a high level of transmembrane protein 106B aggregates, which are thioflavin-S-labeled Biondi ring structures, in the choroid plexus epithelium and co-localization with PM-PBB3-stained structures. In contrast, co-localization of flortaucipir with TMEM106B immunoreactivity was not confirmed because flortaucipir had a low fluorescence intensity. In vitro binding assays for [¹⁸F]PM-PBB3 and [¹⁸F]flortaucipir demonstrated high affinities for collagenase A-treated choroid plexus homogenate containing transmembrane protein 106B aggregates.

CONCLUSION:

This study demonstrated high affinity of [¹⁸F]PM-PBB3 for TMEM106B aggregates in the choroid plexus. In vivo off-target binding of [¹⁸F]PM-PBB3 to the choroid plexus might result from binding to TMEM106B aggregates.

01 Feb 2025·Journal of Nutrition Health & Aging

Impact of diabetes on the progression of Alzheimer’s disease via trajectories of amyloid–tau–neurodegeneration (ATN) biomarkers

Article

Author: Kim, Eosu ; Kim, Eun Woo ; Kim, Keun You

BACKGROUND:

Alzheimer's disease (AD) is characterized by the accumulation of abnormal proteins, such as β-amyloid and tau, in the brain, which precedes cognitive impairment. Although diabetes mellitus (DM) is a well-established risk factor for AD, few studies have investigated how the presence of DM affects the sequential pathogenesis of AD, specifically within the amyloid-tau-neurodegeneration (ATN) and cognition framework.

OBJECTIVES:

This study aims to investigate the trajectories of ATN biomarkers in relation to the presence of DM in the preclinical and prodromal stages of AD.

DESIGN:

Participants with normal cognition (CN) or mild cognitive impairment (MCI) at baseline were included. Subjects were followed for 12-192 months, with neuroimaging and cognitive assessments conducted at every 12 or 24 months.

SETTING:

This study utilized data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database.

PARTICIPANTS:

A total of 603 participants aged 55-90 years were included, comprising 284 CN (25 with DM, 259 without DM) and 319 MCI (39 with DM, 280 without DM) individuals.

MEASUREMENTS:

ATN biomarkers were identified using florbetapir positron emission tomography (PET), flortaucipir PET, and magnetic resonance imaging (MRI), respectively. Cognition was assessed using the Clinical Dementia Rating-Sum of Boxes (CDR-SB) and Mini-Mental State Examination (MMSE). Moderation analysis was conducted to investigate the effect of DM on the association between ATN biomarkers of AD.

RESULTS:

Elevated amyloid standardized uptake value ratios (SUVRs) were associated with increased tau levels in the hippocampus, and this association was significantly enhanced by the presence of DM in MCI participants (p = 0.021). DM also strengthened the association between increased tau SUVR levels and neurodegeneration (indicated by decreased entorhinal cortical volumes; p = 0.005) in those with MCI. Furthermore, DM enhanced the association of decreased entorhinal (p = 0.012) and middle temporal cortex (p = 0.031) volumes with increased (worsened) CDR-SB scores in MCI participants. However, DM did not predict significant longitudinal changes in ATN pathology or cognitive decline in CN participants.

CONCLUSIONS:

Our study suggests that DM may increase the risk of AD by accelerating each step of the A-T-N cascade in the prodromal stage of AD, underscoring the importance of DM management in preventing the MCI conversion to AD.

01 Feb 2025·EUROPEAN ARCHIVES OF PSYCHIATRY AND CLINICAL NEUROSCIENCE

Associations of tau, Aβ, and brain volume of the Papez circuit with cognition in Alzheimer’s disease

Article

Author: Laraib, Azka ; Feng, Yuxue ; Li, Qin ; Li, Xiaofeng ; Lin, Xiuqi ; Zhan, Jiehong

This study aimed to investigate the cross-sectional associations between regional Alzheimer's disease (AD) biomarkers, including tau, β-amyloid (Aβ), and brain volume, within the Papez circuit, and neuropsychological functioning across the preclinical and clinical spectrum of AD. We utilized data from the Alzheimer's Disease Neuroimaging Initiative (ADNI) database, including 251 Aβ-positive participants. Participants were categorized into three groups based on the Clinical Dementia Rating (CDR): 73 individuals with preclinical AD (CDR = 0), 114 with prodromal AD (CDR = 0.5), and 64 with clinical AD dementia (CDR ≥ 1). Linear regression analyses, adjusted for age, gender, and education years, were employed to evaluate the associations between five regions of interest (the hippocampus, para-hippocampus, entorhinal cortex, posterior cingulate cortex, and thalamus) and five neuropsychological tests across the three imaging modalities. In the preclinical stage of AD, flortaucipir PET was associated with impaired global cognition and episodic memory (range standardized β = 0.255-0.498, p < 0.05 corrected for multiple comparisons), while florbetapir PET and brain volume were marginally related to global cognition (range standardized β = 0.221-0.231, p < 0.05). In the clinical stages of AD (prodromal and dementia), both increased flortaucipir uptake and decreased brain volume were significantly associated with poorer global neuropsychological and episodic memory performance (range standardized β = 0.222-0.621, p < 0.05, most regions of interest survived correction for multiple comparisions). However, a slight relationship was observed between florbetapir uptake and poorer global cognitive function. The regions most affected by flortaucipir PET were the hippocampus, para-hippocampus, and posterior cingulate cortex. During the clinical stages, the hippocampus and entorhinal cortex exhibited the most significant volumetric changes. Tau PET and brain volume measurements within the Papez circuit are more sensitive indicators of early cognitive deficits in AD than Aβ PET. Furthermore, during the clinical stages of AD, both flortaucipir PET and brain volume of the Papez circuit are closely correlated with cognitive decline. These findings underscore the importance of integrating multiple biomarkers for the comprehensive evaluation of AD pathology and its impact on cognition.

News (Medical) associated with Flortaucipir F-18

28 Jun 2024

·www.fiercepharma.com

EU's drug regulator again rejects Apellis' eye med and PTC's Translarna in busy week of up-and-down decisions

Drug reviewers at the European Medicines Agency have given a thumbs up for Merck's PAH drug Winrevair and a second thumbs down to Apellis' geographic atrophy treatment Syfovre. For the second time in six months, Europe’s Committee for Medicinal Products for Human Use (CHMP) has given a thumbs down to Apellis’ Syfovre for the treatment of patients with geographic atrophy (GA) caused by age-related macular degeneration. In a release, Apellis noted that there were “multiple dissenting votes” by CHMP members to the opinion. The company added that it plans to seek a reexamination of the opinion, with a final decision expected in the fourth quarter of this year. “Although the studies showed that Syfovre slowed the growth of geographic atrophy lesions, this did not lead to clinically meaningful benefits for patients,” the CHMP said. “It was noted that benefits of a treatment should impact patients’ everyday functioning, and this was not demonstrated in the studies.” “In terms of safety,” the CHMP continued, “regular injections into the eye carry a significant risk of adverse events, including the development of other forms of AMD or inflammation in the eye, that could further worsen vision.” In January of this year, the CHMP adopted its first negative opinion on Syfovre. The drug was approved by the FDA in February of 2023 and generated $275 million in sales last year despite early reports of inflammation for some users. In May, the company said that it holds an 85% share of the market in GA, but admitted to challenges with its launch. In the indication, Apellis is competing with Astellas’ Izervay, which has filed for approval in Europe. Mizuho Securities analyst Graig Suvannavejh noted that there was a 5% drop in Apellis' share price on Friday morning. "There have yet to be data convincingly demonstrating Syfovre use leading to clear, clinically meaningful functional benefit," Suvannavejh wrote in a note to clients. "Moreover, from a drug approval perspective, we view the European Medicines Agency as typically more conservative than the FDA. As such, we lower our probability of success for Syfovre's EU approval from 20% to 10%." Other CHMP rejections Syfovre was not the only drug that was beaten back by the CHMP more than once. The European drug reviewers have once again recommended not renewing the marketing authorization for PTC Therapeutics’ Translarna as a treatment for Duchenne muscular dystrophy. This negative opinion follows the European Commission’s May decision to not adopt the CHMP’s negative opinion from January. By that time, The CHMP had already reviewed and declined to renew the drug’s conditional nod twice. According to PTC, the scientific advisory group convened for the latest review concluded that the evidence of significant efficacy provided by the STRIDE trial "should not be ignored." And yet, the agency still maintained its previous stance. Now, PTC plans to request a reexamination of the CHMP’s third opinion. After that, the European Commission will make a decision. Based on the timeline of these procedures, PTC said it expects Translarna to remain on the market through the end of 2024 even if the negative opinion holds. Elsewhere, the CHMP also refused to recommend a marketing authorization for AB Science’s masitinib, a treatment for the nervous system disorder amyotrophic lateral sclerosis (ALS). The France-based company said it will ask for a reexamination. The CHMP also recommended that the marketing authorization for Advanz's Ocaliva be revoked for the treatment of patients with primary biliary cholangitis. Positive CHMP opinions Meanwhile, the CHMP this week issued positive recommendations for several therapies, including Merck’s blockbuster-to-be Winrevair for pulmonary arterial hypertension (PAH). Winrevair, which gained a high-profile approval from the FDA in March, is the first disease-modifying treatment for the condition. Winrevair, which was acquired by Merck in an $11.5 billion buyout of Acceleron in 2021, has been pegged by J.P Morgan analyst Chris Schott to achieve peak sales between $3 billion and $4 billion. The CHMP also recommended ARS Pharmaceuticals’ marketing application for the adrenaline nasal spray Eurneffy to be approved. It would become the first needle-free adrenaline option in Europe for the treatment of emergency Type 1 allergic reactions (anaphylaxis), which include those to food and insect bites. ARS expects to receive authorization from the EU in the third quarter and to launch Eurneffy in the fourth quarter. The company also hopes for approval of the product from the FDA, with a decision date set for October 2 of this year. The CHMP recommended Johnson & Johnson’s Balversa for the treatment of patients with unresectable or metastatic urothelial carcinoma, a type of bladder cancer. The FDA signed off on Balversa in the indication in January of this year, turning a 2019 accelerated approval into a full nod. Moderna’s respiratory syncytial virus (RSV) vaccine mRasvia has made the grade with the CHMP, too, gaining a recommendation for adults ages 60 and older. The shot, which was approved by the FDA four weeks ago, is the first mRNA vaccine targeting a pathogen other than the coronavirus to receive a positive opinion from the CHMP. Regeneron’s CD20xCD3 bispecific T-cell engager Ordspono (odronestamab) netted a positive opinion from the CHMP to treat two types of blood cancers—follicular lymphoma and diffuse large B-cell lymphoma. The thumbs up comes three months after the FDA sent two complete response letters to Regeneron for the same indications, questioning the timelines of the company’s confirmatory trials. The CHMP recommended Roche’s Piasky (crovalimab) for marketing authorization, just four days after the FDA endorsed it for patients age 13 and older with paroxysmal nocturnal hemoglobinuria (PNH), a rare, genetic life-threatening disorder of the immune system that causes premature breakdown of the red blood cells. The CHMP also has issued a positive opinion on Eli Lilly’s Tauvid (flortaucipir), the first drug used to image a characteristic of Alzheimer’s disease in the brain called tau pathology. The FDA signed off on Tauvid four weeks ago. Also making the grade from the CHMP was Celltrion’s Steqeyma, which is a biosimilar of J&J’s Stelara. It has been recommended for patients with Crohn’s disease, plaque psoriasis and psoriatic arthritis.

Drug ApprovalVaccineAccelerated Approval

14 Jun 2024

·www.biospace.com

With Donanemab on the Cusp of Approval, Proper Alzheimer’s Diagnosis Is Urgent

Pictured: Abstract visualization of human brain/iStock, bawanch An FDA advisory committee on Monday unanimously voted for the approval of Eli Lilly’s anti-amyloid antibody donanemab, concluding that the benefits outweighed the risk for Alzheimer’s disease patients. At the same time, thousands of physicians, technologists, lab professionals, scientists and others attended the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2024 annual meeting in Toronto. Many of the speakers at SNMMI 2024 discussed donanemab and other anti-amyloid drugs and the urgent need to properly diagnose Alzheimer’s so these therapies will benefit patients. Despite other targets, amyloid beta and tau remain critical to the Alzheimer’s treatment landscape, with Eisai and Biogen’s Leqembi in July 2023 becoming the first ever anti-amyloid antibody and disease-altering treatment to be granted traditional FDA approval. Mary Ellen Koran, assistant professor of radiology in the Nuclear Medicine Section at the Mayo Clinic Arizona, emphasized in an SNMMI 2024 presentation that the imaging of brain pathologies is critical, particularly with the advent of anti-amyloid drugs. “It turns out that clinically diagnosing Alzheimer’s disease is very difficult,” Koran said at SNMMI 2024. “Even in specialized dementia centers, there’s a misdiagnosis of Alzheimer’s disease of over a quarter of patients. This is really important now that we have therapies that are actually targeting these pathologies.” Koran pointed to a study published in JAMA Neurology that found as many as one-third of patients clinically diagnosed with mild to moderate Alzheimer’s disease had minimal amyloid accumulation in their brains and risked having limited or no benefit from anti-amyloid treatment. “If you’re giving them a drug based on clinical diagnosis, you’re not giving these patients the right drug, and you’re not giving the right patients the drugs for the clinical trials,” she said. “This is where imaging becomes so important.” The Amyloid PET Quandary Positron emission tomography (PET) scans are a particularly critical component of the diagnosis and treatment of Alzheimer’s disease (AD). Last week, ahead of Monday’s advisory committee meeting, FDA staffers noted that donanemab treatment “demonstrated a statistically significant effect on change from baseline in brain amyloid plaque as measured by PET.” The agency also said that “the use of reduction of amyloid plaques on PET as a surrogate endpoint [is] reasonably likely to predict clinical benefit in patients with early symptomatic stages of AD.” The Alzheimer’s Drug Discovery Foundation (ADDF) has called Lilly’s TRAILBLAZER-ALZ 2 donanemab trial “emblematic of a new era” in research in which patients most likely to benefit from treatment are identified in the early stages of AD. “A unique aspect of this trial was the use of both the Amyvid and Tauvid PET scans to enroll patients with confirmed amyloid plaques, allowing investigators to confirm clearance or reduction of the pathology in later scans,” according to ADDF. At SNMMI 2024, Koran similarly commented that in Lilly’s TRAILBLAZER-ALZ 2 trial, “there were multiple amyloid PET images taken throughout the course of treatment,” which is “pretty cool” for the Alzheimer’s imaging community as such “quantification” of images “may actually inform therapy.” On the reimbursement side, an October 2023 decision by the Centers for Medicare and Medicaid Services (CMS) expanded coverage of PET imaging for diagnosing AD, potentially enabling greater access to new therapies for patients. “It makes us, as nuclear medicine physicians, very relevant to the treatment of these patients,” Koran said. However, Satoshi Minoshima, chair of the Department of Radiology and Imaging Sciences at the University of Utah, provided a sobering assessment at SNMMI 2024 of the challenges facing anti-amyloid therapy in the U.S., including limited scanner capacity, shortages of radiologists and cognitive disorder specialists and unreliable PET interpretation. “Resource limitation is a major challenge for the health system,” Minoshima said, noting it’s a problem that will only get worse as anti-amyloid antibodies like donanemab come to market. The new CMS policy to pay for amyloid PET scans beyond clinical trials is already having a big impact. Minoshima provided a chart with the latest nationwide data on patient volume in the U.S., which showed a 5- to 10-fold increase since October 2023. “Amyloid PET imaging use is really escalating nationally,” he warned. It seems the dam is about to break. Greg Slabodkin is the news editor at BioSpace. You can reach him at greg.slabodkin@biospace.com. Follow him on LinkedIn.

Drug Approval

08 Mar 2024

·www.prnewswire.com

Alzheimer's Drug Discovery Foundation (ADDF) Statement on FDA Decision to Convene Advisory Committee for Donanemab

The FDA plans to hold an advisory committee to glean more information on the TRAILBLAZER-ALZ 2 trial data and safety profile. NEW YORK , March 8, 2024 /PRNewswire/ -- Drugmaker Eli Lilly & Company today announced the FDA expects to convene a meeting of the Peripheral and Central Nervous System Drugs Advisory Committee to further review and discuss donanemab's efficacy and safety profile before making its final decision on whether to grant the drug approval. The advisory committee is scheduled to take place later this year. "Today's FDA decision is not a setback, but another step forward in the drug approval process, with the regulatory agency doing its due diligence before the distribution of the drug to patients," says Howard Fillit, MD, Co-Founder and Chief Science Officer of the Alzheimer's Drug Discovery Foundation (ADDF). "The decision to hold an advisory committee before granting approval follows the regulatory process that was used for the other drugs in this class, including Leqembi." This news does not take away from the breakthroughs the first class of disease modifying treatments have brought to the Alzheimer's landscape, which have proven the field's ability to conduct and design rigorous clinical trials. "The TRAILBLAZER-ALZ 2 trial is emblematic of a new era of Alzheimer's research where we are now able to conduct innovative trials that can definitively tell us whether a drug is effective. As the first class of Alzheimer's drugs come to market—with the promise of more novel therapies to follow—the field is working together to build the path forward for future drug approvals." The donanemab trial used a "goldilocks strategy" to identify patients who were in the early stages of Alzheimer's and most likely to benefit from treatment. A unique aspect of this trial was the use of both the Amyvid® and Tauvid™ PET scans to enroll patients with confirmed amyloid plaques, allowing investigators to confirm clearance or reduction of the pathology in later scans. Lilly's innovative biomarker-powered trial exemplifies the importance of developing biomarkers and drugs in tandem to support drug development, trial enrollment, and target engagement. Based on the broader biology of aging framework, anti-amyloid therapies will serve as the first line of defense in the arsenal of drugs needed to treat Alzheimer's. Currently, nearly 75% of Alzheimer's drugs in development are exploring novel targets related to the various aging pathways like inflammation, metabolic disturbances, and vascular dysfunction. The ultimate goal is to combine amyloid-clearing drugs with novel therapies in a precision medicine approach based on each patient's individual biomarker profile—like within cancer care. Early detection and intervention will be further supported by more accessible and scalable blood-based biomarkers like ALZpath's pTau 217 assay and C2N Diagnostic's Precivity AD test, both of which received ADDF funding. Today's news follows the FDA approval of anti-amyloid Leqembi last July, the first-ever disease modifying therapy for Alzheimer's to receive traditional approval. "Anti-amyloids are only one part of the solution. There remains a pressing need to develop the next generation of drugs and biomarkers targeting the various aging pathways that can be administered via a combination therapy and precision medicine approach," notes Dr. Fillit. "It is crucial we build on recent momentum to move towards a future where we can halt the progression of Alzheimer's or prevent it altogether by addressing the complexity of the disease with an arsenal of novel drugs guided by the biology of aging." About The Alzheimer's Drug Discovery Foundation (ADDF) Founded in 1998 by Leonard A. and Ronald S. Lauder, the Alzheimer's Drug Discovery Foundation is dedicated to rapidly accelerating the discovery of drugs to prevent, treat and cure Alzheimer's disease. The ADDF is the only public charity solely focused on funding the development of drugs for Alzheimer's, employing a venture philanthropy model to support research in academia and the biotech industry. The ADDF's leadership and contributions to the field have played a pivotal role in bringing the first Alzheimer's PET scan (Amyvid®) and blood test (PrecivityAD®) to market, as well as fueling the current robust and diverse drug pipeline. Through the generosity of its donors, the ADDF has awarded more than $290 million to fund over 750 Alzheimer's drug discovery programs, biomarker programs and clinical trials in 20 countries. To learn more, please visit: . SOURCE Alzheimer's Drug Discovery Foundation

Drug ApprovalClinical Study

100 Deals associated with Flortaucipir F-18

External Link

KEGG	Wiki	ATC	Drug Bank
-	Flortaucipir F-18	V04C	DB14914

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Dementia due to Alzheimer's disease (disorder)	GB	Eli Lilly Nederland BV	23 Nov 2024
Mild cognitive disorder	GB	Eli Lilly Nederland BV	23 Nov 2024
Contrast agents	EU	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	IS	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	LI	Eli Lilly Nederland BV	22 Aug 2024
Contrast agents	NO	Eli Lilly Nederland BV	22 Aug 2024
Alzheimer Disease	US	Avid Radiopharmaceuticals, Inc.	28 May 2020

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Neurodegenerative Diseases	Phase 3	US	Avid Radiopharmaceuticals, Inc.	01 Sep 2016
Brain Injuries, Traumatic	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Dec 2014
Depressive Disorder	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Dec 2014
Chronic Traumatic Encephalopathy	Phase 2	US	Avid Radiopharmaceuticals, Inc.	01 Jun 2014
Frontotemporal Dementia	Phase 1	US	Avid Radiopharmaceuticals, Inc.	11 Apr 2017
Cognition Disorders	Phase 1	US	Avid Radiopharmaceuticals, Inc.	01 Aug 2016
Corticobasal degeneration	Phase 1	US	Avid Radiopharmaceuticals, Inc.	12 Aug 2014
Supranuclear Palsy, Progressive	Phase 1	US	Avid Radiopharmaceuticals, Inc.	12 Aug 2014
Cognitive Dysfunction	Phase 1	US	Avid Radiopharmaceuticals, Inc.	13 Nov 2013
Aphasia	Phase 1	US	Northwestern University	-

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04080544 (CTgov)	Phase 2	Alzheimer Disease \| Cognitive Dysfunction	125	Positron Emission Tomography+[18F]AV-1451	nfsuhkeosl(jsdxvhievf) = ckisbubfkj tigullglji (lrsumghtpv, sazdwfzefm - hrlqkgwbov) View more	-	28 Sep 2023
SNMMI2023	Not Applicable	-	-	TAUVID[18F]PI-2620 ([18F]PI-2620)	viskdixyzv(pauctnylnh) = qcsdttlhzp qejlyryyhq (xcyuirtdpf, 8)	-	28 Aug 2023
				[18F]T807TAUVID ([18F]T807)	viskdixyzv(pauctnylnh) = zhqkdoiael qejlyryyhq (xcyuirtdpf, 7)
SNMMI2022	Not Applicable	Chronic Traumatic Encephalopathy	-	Flortaucipir	tbwtfqvbjd(lqyzpbvnud) = xdgryqszth bhsygogpjm (qzyiuwyknv, 10.5)	-	08 Aug 2022
				MK-6240	tbwtfqvbjd(lqyzpbvnud) = qrmbmbbnag bhsygogpjm (qzyiuwyknv )
AAIC2022	Not Applicable	-	661	[18F]Flortaucipir	dzmpshxzir(ljocpczidc) = qlccsuuhim nntvdfgjlv (kczjmwvyme, 88.2 - 95.2) View more	-	01 Feb 2022
				[18F]Flortaucipir (Amyloid PET)	dzmpshxzir(ljocpczidc) = aiicbwcbmp nntvdfgjlv (kczjmwvyme, 88.7 - 95.5) View more
ADNI (AAIC2020)	Not Applicable	tau PET	458	[18F] flortaucipir (AD)	fjpmqqhmaz(hqtgsgjouy) = zzdojfkokc xsxgtzpfsd (rccupxsmjs ) View more	-	07 Dec 2020
				[18F] flortaucipir (MCI)	fjpmqqhmaz(hqtgsgjouy) = lcrgzcicwv xsxgtzpfsd (rccupxsmjs ) View more
NCT03040713 (CTgov)	Phase 1	Frontotemporal Dementia	16	Brain PET scan+Flortaucipir F18	iqwicwqzkf(praumkropg) = inckjssmhj qqfjfkmiaz (gqwbmupwon, pxedypspgg - vdftsqwonh) View more	-	25 Sep 2020
NCT04474405 (CTgov)	Early Phase 1	Alzheimer Disease \| Cognitive Dysfunction	36	Whole body PET scan+Flortaucipir F18 (Whole Body Flortaucipir PET Scan)	hdzlodwtzo(ievzkezzmz) = mkhytqzfho vrdqdkihzs (cgfjsvmwgu, fqhgassdaw - wrvyswvtcw) View more	-	25 Sep 2020
				Brain MRI+Florbetapir F 18 (MRI and Amyloid Extension Cohort)	umjaxdbikg(bxsfzgkkcu) = tkiznckiod rmbflxvdqz (gylqbzkbqa, sdhvgyculf - vsnwhbfczz) View more
NCT02278367 (CTgov)	Phase 2	Alzheimer Disease \| Depressive Disorder \| Brain Injuries, Traumatic	179	flortaucipir (Cognitively Impaired)	khlizhiref(slqfowcueu) = tjnkkgitkv zivwtowekw (tsnhlcvknx, regdhjbgtr - kjwkwvxjaa) View more	-	10 Sep 2020
				flortaucipir (Cognitively Normal)	khlizhiref(slqfowcueu) = bjwohsaqrv zivwtowekw (tsnhlcvknx, eaudioowrk - bywzoptmwu) View more
NCT02051764 (CTgov)	Phase 2	Alzheimer Disease	44	flortaucipir (Cognitively Impaired)	gjqmshruaf(aixociwfip) = qenedbekna jriyxfidvq (vpgmsugqpy, crnmmfjpoz - ocudyuaktd) View more	-	07 Sep 2020
				flortaucipir (Healthy Volunteers)	gjqmshruaf(aixociwfip) = slapftiuzm jriyxfidvq (vpgmsugqpy, mwljtfmnyw - qsupkactkl) View more
NCT01992380 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction	24	Brain PET scan+Flortaucipir F18 (Healthy Volunteer Subjects)	lmosjaudqp(udlxgczkep) = yadhszgrvx lysmuwmdyn (txpdagvasd, axadhxyqmq - fualxeaodp) View more	-	07 Sep 2020
				Brain PET scan+Flortaucipir F18 (MCI Subjects)	lmosjaudqp(udlxgczkep) = xgkaslzuiy lysmuwmdyn (txpdagvasd, dhxyoacplf - blywgleqtu) View more

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