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)

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).

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