Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)
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.
1 other identifier
interventional
152
1 country
8
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jan 2009
Typical duration for phase_2
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 5, 2009
CompletedFirst Posted
Study publicly available on registry
March 6, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedResults Posted
Study results publicly available
March 28, 2013
CompletedMarch 28, 2013
March 1, 2013
2.9 years
March 5, 2009
December 31, 2012
March 26, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in ADAS-Cog for MCI Subjects
The primary analysis was the comparison in the magnitude of change from baseline in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-Cog) between Aβ+ and Aβ- subjects in the Mild Cognitive Impairment (MCI) population at 36 months adjusting for baseline test score and age at informed consent. ADAS-Cog scores (range 0-70) indicate performance on a series of 11 cognitive tasks where 0 indicates the highest level of cognitive performance and 70 indicates the lowest level of cognitive performance. Change in ADAS-Cog scores were calculated by subtracting the baseline score from the 36 month score (last observation carried forward \[LOCF\]). A change in ADAS-Cog greater than 0 indicates a deterioration in cognitive performance whereas a change in ADAS-Cog less than 0 indicates improved cognitive performance.
Baseline and 36 months
Secondary Outcomes (5)
Cognitive Decline in MCI Subjects
Baseline and 36 months
Change in ADAS-Cog in CN and AD Subjects
Baseline and 36 months
Cognitive Decline in CN and AD Subjects
Baseline and 36 months
Covariate Adjusted Psychometric Score Change
Baseline and 36 months
Correlation of Change in ADAS-Cog and SUVR
Baseline and 36 months
Interventions
370 Mega Becquerel (10 mCi)
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Tucson, Arizona, 85741, United States
Research Site
Costa Mesa, California, 92626, United States
Research Site
Brooksville, Florida, 34613, United States
Research Site
Hallandale, Florida, 33009, United States
Research Site
West Palm Beach, Florida, 33407, United States
Research Site
Albany, New York, 12208, United States
Research Site
Durham, North Carolina, 27710, United States
Related Publications (1)
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.
PMID: 24716655DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avid Radiopharmaceuticals, Inc.
Study Officials
- STUDY DIRECTOR
Chief Medical Officer
Avid Radiopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 5, 2009
First Posted
March 6, 2009
Study Start
January 1, 2009
Primary Completion
December 1, 2011
Study Completion
December 1, 2011
Last Updated
March 28, 2013
Results First Posted
March 28, 2013
Record last verified: 2013-03