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| Sponsor: | Avid Radiopharmaceuticals |
|---|---|
| Information provided by: | 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 |
Other: Cognitive and psychometric evaluations |
Phase II |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2009 |
| Estimated Study Completion Date: | April 2012 |
| Estimated Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
Cognitive performance
Cognitive performance of all subjects having received 18F-AV-45 PET scan in prior trial
|
Other: Cognitive and psychometric evaluations
CDR, DSRS, MMSE, Alzheimer's Disease Assessment Scale (ADAS), Wechsler Logical Memory I & II, story A, Digit-Symbol Substitution, Category Verbal Fluency, Geriatric Depression Scale (GDS) and the Alzheimer's Disease Clinical Studies Consortium Activities of Daily Living (ADCS ADL)
Other Names:
|
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 |
| Sampling Method: | Non-Probability Sample |
Subjects with normal cognitive function
Subjects with mild cognitive impairment
Subjects with Alzheimer's disease
Inclusion Criteria:
Exclusion Criteria:
-
Contacts and 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 | |
More Information
| Responsible Party: | Michael J. Pontecorvo, Ph.D., Vice President, Clinical Development, Avid Radiopharmaceuticals, Inc. |
| ClinicalTrials.gov Identifier: | NCT00857506 History of Changes |
| Other Study ID Numbers: | 18F-AV-45-A11 |
| Study First Received: | March 5, 2009 |
| Last Updated: | July 14, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
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 |
|
Alzheimer Disease Cognition Disorders Dementia Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
