Clinical trial NCT00857506: Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Cognitive outcome
18F-AV-45 PET scan
Amyloid PET scan
Florbetapir F 18 amyloid PET scan
Normal cognition
Change in cognitive status in relation to brain amyloid on PET
Lead sponsor: Avid Radiopharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-03-06
Enrollment: 152
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* All subjects who enrolled in study AV-45-A05(NCT00702143), received 18F-AV-45, and completed a PET scan will be eligible to enroll in this trial.

Exclusion Criteria:

Primary outcomes:
measure: Change in ADAS-Cog for MCI Subjects
timeFrame: Baseline and 36 months
Secondary outcomes:
measure: Cognitive Decline in MCI Subjects
timeFrame: Baseline and 36 months
measure: Change in ADAS-Cog in CN and AD Subjects
timeFrame: Baseline and 36 months
measure: Cognitive Decline in CN and AD Subjects
timeFrame: Baseline and 36 months
measure: Covariate Adjusted Psychometric Score Change
timeFrame: Baseline and 36 months
measure: Correlation of Change in ADAS-Cog and SUVR
timeFrame: Baseline and 36 months
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Research Site
state: Arizona
city: Tucson
country: United States
facility: Research Site
state: Arizona
city: Costa Mesa
country: United States
facility: Research Site
state: California
city: Brooksville
country: United States
facility: Research Site
state: Florida
city: Hallandale Beach
country: United States
facility: Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Research Site
state: Florida
city: Albany
country: United States
facility: Research Site
state: New York
city: Durham
country: United States
facility: Research Site
state: North Carolina
Study officials:
affiliation: Avid Radiopharmaceuticals
name: Chief Medical Officer
role: STUDY_DIRECTOR
References:
citation: Siderowf A, Pontecorvo MJ, Shill HA, Mintun MA, Arora A, Joshi AD, Lu M, Adler CH, Galasko D, Liebsack C, Skovronsky DM, Sabbagh MN. PET imaging of amyloid with Florbetapir F 18 and PET imaging of dopamine degeneration with 18F-AV-133 (florbenazine) in patients with Alzheimer's disease and Lewy body disorders. BMC Neurol. 2014 Apr 9;14:79. doi: 10.1186/1471-2377-14-79.