CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 205 enrolled
Drug / intervention
flortaucipir F18 +1 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/NCT03901105
NCT03901105Phase 3Completed
CompareCT.gov

Evaluation of the Relationship Between Baseline Flortaucipir PET Signal and Cognitive Change in Subjects With Early Alzheimer's Disease Participating in the I8D-MC-AZES Protocol Addendum D5010C00009 (2.1) (Tau Imaging)

Avid Radiopharmaceuticals·interventional·Posted Apr 3, 2019·Updated Aug 28, 2020

In Brief

A Phase 3 clinical trial evaluating flortaucipir F18 and Brain PET Scan for Alzheimer Disease. Completed, enrolled 205 participants across 1 site.

Detailed Summary

This study will evaluate whether visual interpretation of flortaucipir-PET (positron emission tomography) scans, examining patterns of tracer uptake at baseline, can predict the rate of clinically-meaningful cognitive decline due to AD after 18 months. All scans are acquired from cohorts of a previously completed study, I8D-MC-AZES (NCT02245737, lanabecestat, Eli Lilly and Company sponsor).

Study Details

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

Timeline

Phase 3CompletedFinished
2020202120222023202420252026
First PostedApr 3, 2019
Enrollment StartMar 28, 2019
Primary CompletionApr 28, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 7.2 years ago

Interventions

flortaucipir F18drug

No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) at baseline will be read by independent, blinded readers. IV injection, 240 megabecquerel (MBq) (6.5 mCi), single dose in AZES

Brain PET Scanprocedure

positron emission tomography (PET) scan of the brain