Mild Cognitive Impairment Clinical Trial
Official title:
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.
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 AV-45-A11 is designed to determine if brain amyloid aggregation imaged on 18F-AV-45
PET scans is predictive of progression of cognitive impairment during the subsequent 36
months. Approximately 180 subjects enrolled in a prior clinical study
(AV-45-A05[NCT00702143]) will be offered an opportunity to be studied under this protocol.
The initial visit will occur as soon as possible following the AV-45-A05(NCT00702143)
imaging day. Subjects who qualify for the study and their caregiver/partners will be
contacted approximately 6,12,18,24 and 36 months after PET imaging in study
AV-45-A05(NCT00702143), and will undergo a standardized functional and psychometric
evaluation.
NOTE: This study is a clinical follow-up of subjects previously enrolled in trial
18F-AV-45-A05(NCT00702143). No new patients are being enrolled in this trial.
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Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic
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