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

• Status: Completed
• Trial end date: 2019-04-28
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Avid Radiopharmaceuticals

Criteria

Scan Reader Criteria (5 total readers):

• Board-certified in radiology or nuclear medicine

• Professional experience interpreting PET scans

Scan Criteria (205 total scans):

• Former enrollment in AZES Study

• Flortaucipir scan at baseline

• clinical dementia rating - sum of boxes (CDR-SB) assessment at 18 months

Scan Study Population (AZES Study):

• 55 to 85 years

• MCI due to AD or probable AD by National Institute on Aging-Alzheimer's Association criteria (Albert 2011

• mini-mental status exam (MMSE) of 20 to 30 inclusive

• CDR global score of 0.5 (MCI), or 0.5 or 1 (AD) with a memory box score ≥ 0.5, and a score of ≤85 on the Delayed Memory Index of the Repeatable Battery for the Assessment of Neuropsychological Status.

• Amyloid positive status confirmed by florbetapir PET or lumbar puncture