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.

NCT05658913 / RecruitingNot ApplicableIIT

Tau PET/CT Imaging in the Mismatch Prospective Cohort Study (MPC-TAU)

To collect Tau PET/CT imaging in older adults diagnosed with Mild Cognitive Impairment (MCI) or Alzheimer's Disease (AD) in the Mismatch Prospective Cohort Study (MPC-Tau) study to determine relationship to clinical, cognitive, and other biomarker data. Findings from this study will likely provide insight into the phenotypic variability of Alzheimer's Disease and other related pathologies.

Start Date14 Mar 2023

Sponsor / Collaborator

University of Pennsylvania

NCT05393388 / RecruitingNot ApplicableIIT

Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study

We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.

Start Date09 May 2022

Sponsor / Collaborator

University of Pennsylvania

[+1]

100 Clinical Results associated with Flortaucipir F-18

100 Translational Medicine associated with Flortaucipir F-18

100 Patents (Medical) associated with Flortaucipir F-18

153

Literatures (Medical) associated with Flortaucipir F-18

19 Sep 2024·ACTA NEUROPATHOLOGICA

Association of in vivo retention of [¹⁸f] flortaucipir pet with tau neuropathology in corresponding brain regions.

Article

Author: Serrano, Geidy E ; Strandberg, Olof ; Leuzy, Antoine ; Hansson, Oskar ; Oliveira Hauer, Kevin ; Pawlik, Daria ; Beach, Thomas G ; Ossenkoppele, Rik ; Rittmo, Jonathan ; Smith, Ruben ; Freiburghaus, Tove ; Tremblay, Cécilia ; Pontecorvo, Michael J

[¹⁸F]Flortaucipir is an FDA-approved tau-PET tracer that is increasingly utilized in clinical settings for the diagnosis of Alzheimer's disease. Still, a large-scale comparison of the in vivo PET uptake to quantitative post-mortem tau pathology and to other co-pathologies is lacking. Here, we examined the correlation between in vivo [¹⁸F]flortaucipir PET uptake and quantitative post-mortem tau pathology in corresponding brain regions from the AVID A16 end-of-life study (n = 63). All participants underwent [¹⁸F]flortaucipir PET scans prior to death, followed by a detailed post-mortem neuropathological examination using AT8 (tau) immunohistochemistry. Correlations between [¹⁸F]flortaucipir standardized uptake value ratios (SUVRs) and AT8 immunohistochemistry were assessed across 18 regions-of-interest (ROIs). To assess [¹⁸F]flortaucipir specificity and level of detection for tau pathology, correlations between [¹⁸F]flortaucipir SUVR and neuritic plaque score and TDP-43 stage were also computed and retention was further assessed in individuals with possible primary age-related tauopathy (PART), defined as Thal phase ≤ 2 and Braak stage I-IV. We found modest-to-strong correlations between in vivo [¹⁸F]flortaucipir SUVR and post-mortem tau pathology density in corresponding brain regions in all neocortical regions analyzed (rho-range = 0.61-0.79, p < 0.0001 for all). The detection threshold of [¹⁸F]flortaucipir PET was determined to be 0.85% of surface area affected by tau pathology in a temporal meta-ROI, and 0.15% in a larger cortical meta-ROI. No significant associations were found between [¹⁸F]flortaucipir SUVRs and post-mortem tau pathology in individuals with possible PART. Further, there was no correlation observed between [¹⁸F]flortaucipir and level of amyloid-β neuritic plaque load (rho-range = - 0.16-0.12; p = 0.48-0.61) or TDP-43 stage (rho-range = - 0.10 to - 0.30; p = 0.18-0.65). In conclusion, our in vivo vs post-mortem study shows that the in vivo [¹⁸F]flortaucipir PET signal primarily reflects tau pathology, also at relatively low densities of tau proteinopathy, and does not bind substantially to tau neurites in neuritic plaques or in individuals with PART.

02 Jul 2024·Chembiochem : a European journal of chemical biology

Role of Amyloidogenic and Non‐Amyloidogenic Protein Spaces in Neurodegenerative Diseases and their Mitigation Using Theranostic Agents

Review

Author: Gupta, Vishakha ; Murugan, N. Arul ; Kumar, Virendra ; Ramesh, Madhu ; Suri, Kapali ; Govindaraju, Thimmaiah ; Bhandari, Mansi

Abstract:

Neurodegenerative diseases (NDDs) refer to a complex heterogeneous group of diseases which are associated with the accumulation of amyloid fibrils or plaques in the brain leading to progressive loss of neuronal functions. Alzheimer's disease is one of the major NDD responsible for 60–80 % of all dementia cases. Currently, there are no curative or disease‐reversing/modifying molecules for many of the NDDs except a few such as donepezil, rivastigmine, galantamine, carbidopa and levodopa which treat the disease‐associated symptoms. Similarly, there are very few FDA‐approved tracers such as flortaucipir (Tauvid) for tau fibril imaging and florbetaben (Neuraceq), flutemetamol (Vizamyl), and florbetapir (Amyvid) for amyloid imaging available for diagnosis. Recent advances in the cryogenic electron microscopy reported distinctly different microstructures for tau fibrils associated with different tauopathies highlighting the possibility to develop tauopathy‐specific imaging agents and therapeutics. In addition, it is important to identify the proteins that are associated with disease development and progression to know about their 3D structure to develop various diagnostics, therapeutics and theranostic agents. The current article discusses in detail the disease‐associated amyloid and non‐amyloid proteins along with their structural insights. We comprehensively discussed various novel proteins associated with NDDs and their implications in disease pathology. In addition, we document various emerging chemical compounds developed for diagnosis and therapy of different NDDs with special emphasis on theranostic agents for better management of NDDs.

01 Jun 2024·HUMAN BRAIN MAPPING

Multimodal cross‐examination of progressive apraxia of speech by diffusion tensor imaging‐based tractography and Tau‐PET scans

Article

Author: Schwarz, Christopher G. ; Jack, Clifford R. ; Gatto, Rodolfo G. ; Utianski, Rene L. ; Josephs, Keith A. ; Botha, Hugo ; Clark, Heather M. ; Whitwell, Jennifer L. ; Machulda, Mary M. ; Lowe, Val J. ; Duffy, Joseph R. ; Pham, Nha Trang Thu

Abstract:

Progressive apraxia of speech (PAOS) is a 4R tauopathy characterized by difficulties with motor speech planning. Neurodegeneration in PAOS targets the premotor cortex, particularly the supplementary motor area (SMA), with degeneration of white matter (WM) tracts connecting premotor and motor cortices and Broca's area observed on diffusion tensor imaging (DTI). We aimed to assess flortaucipir uptake across speech‐language‐related WM tracts identified using DTI tractography in PAOS. Twenty‐two patients with PAOS and 26 matched healthy controls were recruited by the Neurodegenerative Research Group (NRG) and underwent MRI and flortaucipir‐PET. The patient population included patients with primary progressive apraxia of speech (PPAOS) and non‐fluent variant/agrammatic primary progressive aphasia (agPPA). Flortaucipir PET scans and DTI were coregistered using rigid registration with a mutual information cost function in subject space. Alignments between DTI and flortaucipir PET were inspected in all cases. Whole‐brain tractography was calculated using deterministic algorithms by a tractography reconstruction tool (DSI‐studio) and specific tracts were identified using an automatic fiber tracking atlas‐based method. Fractional anisotropy (FA) and flortaucipir standardized uptake value ratios (SUVRs) were averaged across the frontal aslant tract, arcuate fasciculi, inferior frontal‐occipital fasciculus, inferior and middle longitudinal fasciculi, as well as the SMA commissural fibers. Reduced FA (p < .0001) and elevated flortaucipir SUVR (p = .0012) were observed in PAOS cases compared to controls across all combined WM tracts. For flortaucipir SUVR, the greatest differentiation of PAOS from controls was achieved with the SMA commissural fibers (area under the receiver operator characteristic curve [AUROC] = 0.83), followed by the left arcuate fasciculus (AUROC = 0.75) and left frontal aslant tract (AUROC = 0.71). Our findings demonstrate that flortaucipir uptake is increased across WM tracts related to speech/language difficulties in PAOS.

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
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
Mild cognitive disorder	Phase 3	US	Avid Radiopharmaceuticals, Inc.	01 Dec 2013
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

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	unlamcqfhy(jsqdytiidr) = ijrlqnnhze reozrpeqkb (pezkhvjxli, cjmcyaakrl - jummvxqboh) View more	-	28 Sep 2023
AAIC2022	Not Applicable	-	661	[18F]Flortaucipir	gaulcsbxtf(oalswesicu) = umygiyobwr sghmvznulx (azcdiphfww, 88.2 - 95.2) View more	-	01 Feb 2022
				[18F]Flortaucipir (Amyloid PET)	gaulcsbxtf(oalswesicu) = mauhnvdoaz sghmvznulx (azcdiphfww, 88.7 - 95.5) View more
ADNI (AAIC2020)	Not Applicable	-	458	[18F] flortaucipir (AD)	cynbmiqrqi(gnsuzkgvnu) = pvvxzibxoe ozwcvaksfi (izptjtzyze ) View more	-	07 Dec 2020
				[18F] flortaucipir (MCI)	cynbmiqrqi(gnsuzkgvnu) = trfbxaygfo ozwcvaksfi (izptjtzyze ) View more
NCT04474405 (CTgov)	Early Phase 1	Alzheimer Disease \| Cognitive Dysfunction	36	Whole body PET scan+Flortaucipir F18 (Whole Body Flortaucipir PET Scan)	okxkunitpx(shgvztxbri) = qkcyotqdik gqwalbdcdr (ermbbpfhmh, wojztyzslc - gshqrxfdbk) View more	-	25 Sep 2020
				Brain MRI+Florbetapir F 18 (MRI and Amyloid Extension Cohort)	eenlbypkpf(sqwehrhujq) = qyrjdjrpen qihkhhbefv (byembepkbg, cwwtsxmmif - rxcenjgzsk) View more
NCT03040713 (CTgov)	Phase 1	Frontotemporal Dementia	16	Brain PET scan+Flortaucipir F18	uymdtjxupm(iedvokaqvd) = qqehwqhkmz chkklaktwx (xoyjuexodc, jycspcelmt - xdxaxmaemp) View more	-	25 Sep 2020
NCT02278367 (CTgov)	Phase 2	Alzheimer Disease \| Depressive Disorder \| Brain Injuries, Traumatic	179	flortaucipir (Cognitively Impaired)	vgxpmdjpjl(fngafiusls) = hatwnxygqy sacjweekvr (vthkuzbrye, vazdhyikrw - uyilphtquo) View more	-	10 Sep 2020
				flortaucipir (Cognitively Normal)	vgxpmdjpjl(fngafiusls) = fkeiwjbobf sacjweekvr (vthkuzbrye, ysakwugiqo - eougrjhiup) View more
NCT02051764 (CTgov)	Phase 2	Alzheimer Disease	44	flortaucipir (Cognitively Impaired)	gftguvdmzk(pwkvhzkass) = jprzpuyvwa pfoweuuxui (vpymvssspe, fgjaxwjeum - otkgcpxlkj) View more	-	07 Sep 2020
				flortaucipir (Healthy Volunteers)	gftguvdmzk(pwkvhzkass) = gvxrhoboyx pfoweuuxui (vpymvssspe, dzzeexirnt - nbhliozciv) View more
NCT01992380 (CTgov)	Phase 1	Alzheimer Disease \| Cognitive Dysfunction	24	Brain PET scan+Flortaucipir F18 (Healthy Volunteer Subjects)	kyqhfcjgwn(awhzphhrnh) = zccqlklzpb svntltkvhq (thsknorqpv, aerfdqtnqd - nrvwzdxbqq) View more	-	07 Sep 2020
				Brain PET scan+Flortaucipir F18 (MCI Subjects)	kyqhfcjgwn(awhzphhrnh) = vtxyzwvnpf svntltkvhq (thsknorqpv, ntuconkvoz - dfmzlkcips) View more
NCT03467477 (CTgov)	Phase 2	Alzheimer Disease	161	flortaucipir (Early Symptomatic AD, Eligible for Future Trials)	hzmiyqdnta(heiztffotd) = kdeyxxewia lutsbgfwto (dyuojffrag, zfnkppvbhf - vwxhpxvtrj) View more	-	24 Aug 2020
				flortaucipir (Early Symptomatic AD, Ineligible for Future Trials)	hzmiyqdnta(heiztffotd) = wozvsmtfyi lutsbgfwto (dyuojffrag, hulzszggjk - bwfubovzex) View more
NCT03322462 (CTgov)	Phase 2	Alzheimer Disease	155	flortaucipir (Early Symptomatic AD, Eligible for AACG Study)	dogisimslb(kftbmqmqwz) = pvwjndjgdk csnmwpzofd (nuvbbkaucv, tpkfeykzli - gmxzhwmxpi) View more	-	24 Aug 2020
				flortaucipir (Early Symptomatic AD, Ineligible for AACG Study)	dogisimslb(kftbmqmqwz) = xsvvfmansr csnmwpzofd (nuvbbkaucv, pqtbpfpzyq - yyhevozvak) View more

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Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

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Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis