At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Evaluation of the Ability of a Novel [18F] Amyloid Ligand ([18F]-AV-45) to Distinguish Patients With a Clinical Diagnosis of Alzheimer's Disease From Cognitively Normal Elderly Individuals
In Brief
A Phase 2 clinical trial evaluating florbetapir F 18 and [11C]-PIB for Alzheimer's Disease. Completed, enrolled 28 participants across 1 site.
Detailed Summary
This study will evaluate the performance characteristics of a novel \[18F\] amyloid detection ligand (18F\]-AV-45) with respect to its ability to distinguish patients with clinically-diagnosed probable Alzheimer's disease from cognitively normal elderly subjects and to independently compare its diagnostic performance characteristics with the ability of \[11C\]PIB to correctly categorize the same subjects. SPECIFIC HYPOTHESES 1. Individuals with a clinical diagnosis of probable Alzheimer's disease will have increased brain retention of \[18F\]-AV-45 compared to cognitively normal elderly individuals. 2. There will be no clinically meaningful difference in the amyloid retention performance characteristics of \[18F\]-AV-45 and \[l1C\]PIB.
Study Details
Timeline
Interventions
370 MBq (10 mCi), intravenous (IV) injection, single dose
555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB