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NCT03901105 · ClinicalTrials.gov registry record · Phase 3
Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease
A Phase 3 study, sponsored by Avid Radiopharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 205
- Enrollment target
NCT03901105: Completed Phase 3 study, sponsored by Avid Radiopharmaceuticals.
NCT03901105 is a Phase 3 study that has completed, run by Avid Radiopharmaceuticals. The registered enrollment target is 205 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03901105, a Phase 3 study, has completed, sponsored by Avid Radiopharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 205 participants
- Enrollment target
Study 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).
Primary Outcome
Baseline flortaucipir F 18 PET imaging results were determined by majority read (see Baseline Characteristics for description). Clinically meaningful deterioration (CMD) was defined for the primary endpoint as a worsening of the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score of one point or more. The clinical dementia rating (CDR) examines 6 categories of cognitive functioning domains. Each domain is scored on a scale ranging from 0 to 3 (including 0.5). A CDR-SB was generated as the
Interventions
- PROCEDURE Brain PET Scan
- DRUG flortaucipir F18
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 205 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2019-04-28 |
| Phase | Phase 3 |
What the finished NCT03901105 record still lists
NCT03901105 is an interventional study that assigns participants to a tested intervention. The registered 205 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 2 interventions - of which Brain PET Scan is the first listed.
NCT03901105 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03901105 about?
NCT03901105 is a clinical study titled "Evaluation of Flortaucipir PET Signal and Cognitive Change in Early Alzheimer's Disease". 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 previo...
What is the current status of trial NCT03901105?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 205 participants. The study started on 2019-03-28. Estimated completion is 2019-04-28.
What interventions are being tested in trial NCT03901105?
The interventions under investigation include: Brain PET Scan (PROCEDURE), flortaucipir F18 (DRUG).
Who is sponsoring clinical trial NCT03901105?
This trial is sponsored by Avid Radiopharmaceuticals, which has 42 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03901105's enrollment target sits among peer trials
205 1350th of 2000 higher than 649 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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