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NCT05641688 · ClinicalTrials.gov registry record · Phase 3
[18F]PI-2620 Phase 3 Histopathological Study
A Phase 3 study of Alzheimer Disease, sponsored by Life Molecular Imaging.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT05641688: Recruiting Phase 3 study of Alzheimer Disease, sponsored by Life Molecular Imaging.
NCT05641688 is a Phase 3 study of Alzheimer Disease that is actively recruiting participants, run by Life Molecular Imaging. The registered enrollment target is 200 participants, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05641688, a Phase 3 study of Alzheimer Disease, is actively recruiting participants, sponsored by Life Molecular Imaging.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after death and completion of brain autopsy.
Primary Outcome
\[18F\]PI-2620 PET scans will be classified as either tau-positive or tau-negative as defined by the reading methodology by each of the 5 independent readers blinded to the clinical and pathology information. NFT scores (as defined in Hyman et al. 2012) will be used as pathology assessment SoT (standard of truth). Tau neurofibrillary pathology associated with AD is defined as either negative with NFT Scores of B0 or B1 or positive NFT Scores of B2 or B3. The \[18F\]PI-2620 PET visual assessment
Conditions Studied
Interventions
- DRUG [18F]PI-2620
Study Locations (20)
Florida
- Galiz Research - Hialeah
- UF College of Medicine - Jacksonville - Jacksonville
- K2 Medical Research - Lady Lake
- K2 Medical Research - Maitland
- ClinCloud Research - Melbourne
- Miami Jewish Health Systems - Miami
- The Roskamp Institute - Sarasota
- Charter Research - Winter Park
California
- UC Los Angeles - Los Angeles
- Esperanza Clinical - Murrieta
- Sutter Health - San Francisco
Arizona
- Barrow Neurological Institute - Phoenix
- Banner Sun Health Research Institute - Sun City
Massachusetts
- Alzheimer's Disease Center - Braintree
- Headlands Research - Plymouth
New York
- Velocity Clinical Research - East Syracuse
- Ichor Research - Syracuse
Nebraska
- Be Well Clinical Studies - Lincoln
New Hampshire
- Darthmouth-Hitchcock Medical Center - Lebanon
North Carolina
- American Carolina Clinical Research LLC - Charlotte
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2022-12-01 |
| Est. Completion | 2027-06 |
| Phase | Phase 3 |
What NCT05641688 shows while recruiting
NCT05641688 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Alzheimer Disease appearing as the primary indexed condition, and to 1 intervention - of which [18F]PI-2620 is the first listed.
NCT05641688 names 20 study sites across 8 states, led by Florida, California, Arizona.
Frequently Asked Questions
What is clinical trial NCT05641688 about?
NCT05641688 is a clinical study titled "[18F]PI-2620 Phase 3 Histopathological Study". This study is an open-label, multi-center, non-randomized pivotal Phase 3 study to assess the efficacy and safety of PET imaging with \[18F\]PI-2620 for detection of tau deposition in subjects with Alzheimer's disease (AD) and controls during lifetime when compared to histopathology obtained after d...
What is the current status of trial NCT05641688?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2022-12-01. Estimated completion is 2027-06.
What conditions does trial NCT05641688 study?
This clinical trial studies the following conditions: Alzheimer Disease.
What interventions are being tested in trial NCT05641688?
The interventions under investigation include: [18F]PI-2620 (DRUG).
Who is sponsoring clinical trial NCT05641688?
This trial is sponsored by Life Molecular Imaging, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05641688 being conducted?
This trial has 20 study locations across Arizona, California, Florida, Massachusetts, Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Alzheimer Disease
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05641688's enrollment target sits among peer trials
200 105th of 306 higher than 196 of 306 other Alzheimer Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Alzheimer Disease trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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