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18F-AV-45 PET Imaging in AD, MCI, and Healthy Volunteers
NCT00702143Phase 2
Key facts
- Status
- Completed
- Start
- Jun 2008
- Primary completion
- Dec 2008
- Countries
- 1
- Sponsor
- Avid Radiopharmaceuticals
- Modality
- Small Molecules
- Drugs
- florbetapir (18F)
- Conditions
- Alzheimer's disease (AD)Mild Cognitive Impairment (MCI)
01
Overview
Phase 2, open-label trial of florbetapir (18F) in Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) (3 arms), sponsored by Avid Radiopharmaceuticals. Primary endpoints: Qualitative Amyloid Image Assessment and Mean Cortical to Cerebellum SUVR. Started Jun 2008; status: completed.
02
Design
3 arms- Study design
- Non-randomizedOpen-label
AD subjects
Patients with probable Alzheimer's Disease
MCI Subjects
Patients with Mild Cognitive Impairment
Healthy controls
Healthy volunteers with normal cognition
03
Who it enrols
Inclusion requires age >= 50. AD subjects: MMSE 10-24. MCI subjects: CDR 0.5, MMSE >24. Healthy controls: MMSE >=29, normal psychometric tests.
04
Endpoints
Primary
Qualitative Amyloid Image Assessment
Mean Cortical to Cerebellum SUVR
Secondary
Proportion of Positive Florbetapir-PET Scans
05
Results
Primary endpoints met
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