Clinical trial NCT03901105: Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer Disease
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2019-04-03
Enrollment: 205
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Physician PET scan readers are participants, blinded to demographic and clinical data from the source PET scans.
Primary purpose: DIAGNOSTIC

Brief 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).


Eligibility 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

Primary outcomes:
measure: Risk Ratio for AD Symptom Progression on CDR-SB
timeFrame: Within 18 months of scan
Secondary outcomes:
measure: Risk Ratio for AD Symptom Progression on Various Clinical Measures
timeFrame: Within 18 months of scan
measure: Mean Change in Cognitive/Functional Assessments
timeFrame: baseline and 18 months
measure: Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging
timeFrame: baseline scan
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: American College of Radiology
state: Pennsylvania
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References:
citation: Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.