CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 28 enrolled
Drug / intervention
florbetapir F 18 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00855868
NCT00855868Phase 2Completed

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

Avid Radiopharmaceuticals·interventional·Posted Mar 5, 2009·Updated Jul 26, 2012

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

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 5, 2009
Enrollment StartMar 1, 2009
Primary CompletionJan 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.3 years ago

Interventions

florbetapir F 18drug

370 MBq (10 mCi), intravenous (IV) injection, single dose

[11C]-PIBdrug

555 MBq (15 mCi), IV injection, single dose \[11C\]-PIB