CI

At a glance

ClinicalIndex Comparison Record
Early Ph 1Completed· 36 enrolled
Drug / intervention
Flortaucipir F18 +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04474405
NCT04474405Early Ph 1Completed
CompareCT.gov

An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects

Avid Radiopharmaceuticals·interventional·Posted Jul 16, 2020·Updated Sep 25, 2020

In Brief

A Early Phase 1 clinical trial evaluating Flortaucipir F18, Brain PET Scan, and 3 other interventions for Alzheimer Disease. Completed, enrolled 36 participants across 2 sites.

Detailed Summary

This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAlzheimer Disease
CountriesUnited States
Collaborators--

Timeline

Early Ph 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 16, 2020
Enrollment StartAug 16, 2013
Primary CompletionDec 9, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 6.0 years ago

Interventions

Flortaucipir F18drug

IV injection, 370 MBq (10 mCi), single dose

Brain PET Scanprocedure

positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).

Whole body PET scanprocedure

positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours

Florbetapir F 18drug

IV injection, 370 MBq (10 mCi), single dose

Brain MRIprocedure

Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain