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Sponsors and Collaborators: |
University of California, Los Angeles Centers for Medicare and Medicaid Services |
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Information provided by: | University of California, Los Angeles |
ClinicalTrials.gov Identifier: | NCT00329706 |
A brain PET scan is recognized as "reasonable and necessary" for some patients with "a recently established diagnosis of dementia" (Centers for Medicare and Medicaid Services, Decision Memo CAG-00088R, 2004), but evidence is less clear for patients having less severe cognitive problems. A substantial portion of such patients will develop Alzheimer's disease and other forms of dementia, which affect millions of people in the U.S., costing us over $100 billion annually. This project employs a prospective randomized protocol to determine whether PET scanning can help distinguish those patients with early Alzheimer's changes in their brains from those having other causes of cognitive impairment more accurately than is done with current clinical practices alone, and lead to earlier, more effective therapies which extend patients' abilities to think and function independently.
Condition | Intervention |
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Dementia |
Procedure: FDG-PET brain scan |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind (Subject), Active Control, Parallel Assignment |
Official Title: | Early and Long-Term Value of Imaging Brain Metabolism |
Estimated Enrollment: | 710 |
Study Start Date: | June 2006 |
Estimated Study Completion Date: | January 2012 |
Estimated Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental |
Procedure: FDG-PET brain scan
[F-18]FDG PET brain scan
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2: Active Comparator |
Procedure: FDG-PET brain scan
[F-18]FDG PET brain scan
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People experiencing mild cognitive changes represent an epidemiologically major segment of the geriatric patient population. In the present proposal, we aim to measure how knowledge of cerebral metabolic information 1) influences working diagnoses and management of patients being evaluated for symptoms of early cognitive decline, and 2) impacts upon long-term clinical outcomes, particularly of subjects having metabolic patterns consistent with presence of Alzheimer's disease (AD)-like changes in their brains. A total of 710 patients suffering from documentable decline of cognitive function in the absence of overt dementia will be studied at nine U.S. institutions with extensive experience and infrastructure in place for the evaluation of Alzheimer's disease and related disorders, and for neuroimaging. In this prospective, investigation, subjects will undergo baseline neuropsychologic testing and neuroimaging with MRI and FDGPET. PET scan reports will be sealed and randomized with respect to whether they are released to patients' managing physicians at the time of interpretation, or two years after the time that scanning is performed.
Working diagnoses of managing physicians will be recorded, as will the treatment decisions made by the managing physicians and their patients. Cognitive abilities, functional status, utilization of healthcare resources, and other clinical and social contact parameters will be assessed every six months. Our major hypotheses are that among patients whose PET results are immediately conveyed to their referring physicians, diagnoses and management plans will be positively affected, leading to more effective utilization of healthcare resources and to maintenance of cognitive and functional abilities at a higher level. This project will also provide a rich source of data that can be used to address questions outside of its major focus (e.g., prognostic accuracy of volumetric MRI data used instead of, or in conjunction with, FDG-PET data; incremental predictive value of applying statistically parameterizing and/or quantifying software tools to imaging data).
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Erin Siu, Coordinator | 310-794-5067 | erinsiu@mednet.ucla.edu |
Contact: Daniel H Silverman, MD, Ph.D. | 310-825-4257 | dsilver@ucla.edu |
United States, California | |
UCLA Medical Center | Recruiting |
Los Angeles, California, United States, 90095-6942 | |
Contact: Erin Siu, Coordinator 310-794-5067 erinsiu@mednet.ucla.edu | |
Contact: Daniel H Silverman, MD, PhD 310-825-4257 dsilver@ucla.edu |
Principal Investigator: | Daniel H Silverman, MD, PhD | University of California, Los Angeles |
Responsible Party: | University of California, Los Angeles ( Dr. Daniel H. Silverman, Associate Professor ) |
Study ID Numbers: | 02-10-079, 03-04-026 |
Study First Received: | May 24, 2006 |
Last Updated: | September 19, 2008 |
ClinicalTrials.gov Identifier: | NCT00329706 |
Health Authority: | United States: Institutional Review Board |
mild cognitive impairment Alzheimer's disease dementia FDG PET |
Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Alzheimer Disease Central Nervous System Diseases |
Brain Diseases Dementia Cognition Disorders Delirium |
Nervous System Diseases |