Phase 3
N=205
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
Alzheimer Disease
Bottom Line
View on ClinicalTrials.gov: NCT03901105 ↗Enrolled (actual)
205
Serious AEs
—
Results posted
Aug 2020
Primary outcome: Primary: Risk Ratio for AD Symptom Progression on CDR-SB — 119; 43; 10; 5 Participants — p=0.0313
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- flortaucipir F18 (Drug); Brain PET Scan (Procedure)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Apr 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Risk Ratio for AD Symptom Progression on CDR-SB |
119; 43; 10; 5; 14; 14 | 0.0313 sig |
| SECONDARY Risk Ratio for AD Symptom Progression on Various Clinical Measures |
112; 49; 6; 8; 15; 13 | .0833 |
| SECONDARY Mean Change in Cognitive/Functional Assessments |
2.22; 1.31; -4.89; -2.12; 6.53; 1.97 | .0305 sig |
| SECONDARY Inter-Reader Reliability of Reader Interpretation of Flortaucipir F 18 PET Imaging |
0.754 | — |
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
Data sourced from ClinicalTrials.gov (NCT03901105). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.