CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 152 enrolled
Drug / intervention
florbetapir F 18drug
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/NCT00857506
NCT00857506Phase 2Completed

Longitudinal Study of Long-term (36 Month) Cognitive Outcomes in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD) Who Have Previously Had PET Imaging With 18F-AV-45 Injection.

Avid Radiopharmaceuticals·interventional·Posted Mar 6, 2009·Updated Mar 28, 2013

In Brief

A Phase 2 clinical trial evaluating florbetapir F 18 for Alzheimer's Disease and Mild Cognitive Impairment. Completed, enrolled 152 participants across 8 sites.

Detailed Summary

The primary objective of this protocol is to determine if brain amyloid imaged with florbetapir F 18 (18F-AV-45) PET scans is predictive of progressive cognitive impairment during the subsequent 36 months for groups of: normal controls, mild cognitive impairment and Alzheimer's disease. Hypothesis 1: The probability a subject will experience progressive cognitive impairment within 36 months of imaging will be greater in subjects whose 18F-AV-45 PET scan was rated amyloid positive compared to subjects whose PET scan was rated amyloid negative. The secondary objective is to determine the stability, over 36 months of a clinical diagnosis, of AD in patients with an amyloid positive 18F-AV-45 PET. Hypothesis 2: The diagnosis of AD will remain unchanged in patients whose PET scan were rated as amyloid positive.

Study Details

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

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 6, 2009
Enrollment StartJan 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.9 yearsPosted 17.3 years ago

Interventions

florbetapir F 18drug

370 Mega Becquerel (10 mCi)