Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45) - Full Text View

Sponsor:	Avid Radiopharmaceuticals
Information provided by (Responsible Party):	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00857506

Purpose

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.

Condition	Intervention	Phase
Alzheimer's Disease Mild Cognitive Impairment	Drug: florbetapir F 18	Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Diagnostic
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.

Resource links provided by NLM:

MedlinePlus related topics: Alzheimer's Disease Mild Cognitive Impairment Nuclear Scans

U.S. FDA Resources

Further study details as provided by Avid Radiopharmaceuticals:

Primary Outcome Measures:

Probability of conversion of MCI to AD [ Time Frame: 36 months ] [ Designated as safety issue: No ]
For subjects with mild cognitive impairment (MCI), the proportion of subjects with a positive florbetapir-PET scan who convert from MCI to AD diagnosis compared with the proportion of subjects with a negative scan who convert from MCI to AD diagnosis

Secondary Outcome Measures:

Change in cognitive test score performance [ Time Frame: Baseline and 36 months ] [ Designated as safety issue: No ]
Change from baseline in psychometric test scores.

Enrollment:	152
Study Start Date:	January 2009
Study Completion Date:	December 2011
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Intervention Details:

370 MBq (10 mCi)

Other Names:

18F-AV-45 PET
florbetapir F 18
amyloid imaging
Amyvid

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) 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 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, 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. No new patients are being enrolled in this trial.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00857506

Locations

United States, Arizona
Scottsdale Medical Imaging
Scottsdale, Arizona, United States, 85258
Northwest NeuroSpecialists
Tucson, Arizona, United States, 85741
United States, California
ATP Clinical Research
Costa Mesa, California, United States, 92626
United States, Florida
Meridien Research
Brooksville, Florida, United States, 34613
MD Clinical
Hallandale Beach, Florida, United States, 33009
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, New York
Neurological Associates of Albany, P.C.
Albany, New York, United States, 12208
United States, North Carolina
Duke University Health System
Durham, North Carolina, United States, 27710

Sponsors and Collaborators

Avid Radiopharmaceuticals

Investigators

Study Director:

Chief Medical Officer

Avid Radiopharmaceuticals

More Information

No publications provided

Responsible Party:	Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:	NCT00857506 History of Changes
Other Study ID Numbers:	18F-AV-45-A11
Study First Received:	March 5, 2009
Last Updated:	March 6, 2012
Health Authority:	United States: Food and Drug Administration

Keywords provided by Avid Radiopharmaceuticals:

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

Additional relevant MeSH terms:

Alzheimer Disease
Cognition Disorders
Dementia
Brain Diseases
Central Nervous System Diseases

Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2012