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

Avid Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Alzheimer Disease

Treatments: Drug: flortaucipir F18; Procedure: Brain PET Scan

Study type: Interventional

Funder types: Industry

Identifiers

NCT03901105

18F-AV-1451-PX01

Details and patient eligibility

About

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).

Enrollment: 205 patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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205 participants in 1 patient group

Flortaucipir PET Scan

Experimental group

Description:

No study drug will be administered. Scans previously acquired from Study I8D-MC-AZES (NCT02245737, Eli Lilly and Company sponsor) will be read by independent, blinded readers.

Treatment:

Procedure: Brain PET Scan

Drug: flortaucipir F18