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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 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.

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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.

Conditions Studied

Alzheimer Disease

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

FieldValue
Enrollment Target 200 participants
Start Date 2022-12-01
Est. Completion 2027-06
Phase Phase 3

Sponsor

Life Molecular Imaging

4 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05641688

The ClinicalTrials.gov registry entry for NCT05641688 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,750-participant average among 306 other Alzheimer Disease trials with a reported enrollment target (93% lower). The listed sponsor is Life Molecular Imaging, which has 4 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 8 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.