NCT03901105

Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 205 (actual)
• Sponsor: Avid Radiopharmaceuticals · Industry
• Sex: All
• Age: 55 Years – 85 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DRUG	flortaucipir F18	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
PROCEDURE	Brain PET Scan	positron emission tomography (PET) scan of the brain

Timeline

• Start date: 2019-03-28
• Primary completion: 2019-04-28
• Completion: 2019-04-28
• First posted: 2019-04-03
• Last updated: 2020-08-28
• Results posted: 2020-08-28

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study