Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
Overall Status:
Recruiting
Brief Description:
This prospective, randomized study will examine whether positron emission tomography (PET) scanning can help distinguish patients with early Alzheimer's changes in their brains from those having other causes of cognitive impairment more accurately than current clinical practices.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
65 Years | N/A | Both | No |
Inclusion Criteria:
- Cognitive deficit and/or personality change, observable by physician and/or close contact; in the absence of this, clear history of decline that the participant's physician deems reliable
- If history or neurologic exam reveals suspicion of stroke, tumor, bleeding, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must be obtained.
- If present, appropriate treatment of depression, substance abuse, malnourishment, medication effects and interactions, cardiopulmonary compromise, electrolyte/calcium imbalance, anemia, hypoxemia, infection, thyroid dysfunction, renal dysfunction, hepatic dysfunction, or glucose dysregulation
Exclusion Criteria:
- Overt dementia with impaired ability to perform activities of daily living
- Present or past history of thyroid disease
- Claustrophobia, metal in body, or other condition that would preclude PET or MRI
- Visual, auditory, or motor deficits that would preclude accurate neuropsychological testing
- Prohibited medications: Cholinesterase inhibitors
Detailed Description:
This study is designed to measure how knowledge of cerebral metabolic information influences the diagnosis and management of patients being evaluated for symptoms of early cognitive decline. It will also evaluate the impact on long-term clinical outcomes, particularly of subjects having metabolic patterns consistent with Alzheimer's disease-like changes in their brains.
In this prospective investigation, subjects will undergo baseline neuropsychological testing and neuroimaging with MRI and FDG PET. PET scan reports will be sealed and randomized, released to patients' managing physicians either at the time of interpretation or 2 years after scanning. Managing physicians' working diagnoses and treatment decisions will be recorded. Cognitive abilities, functional status, utilization of healthcare resources, and other clinical and social contact parameters will be assessed every 6 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 maintenance of cognitive and functional abilities at a higher level.
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.6923299, -111.9403254 | Mayo Clinic | Phoenix | Arizona | 85054 | Recruiting | |
Geolocation is 34.070264, -118.4440562 | UCLA Medical Center | Los Angeles | California | 90095-6942 | Recruiting | |
Geolocation is 34.0741548, -118.3724915 | Cedars-Sinai Medical Center | Los Angeles | California | 90048 | Recruiting | |
Geolocation is 34.02875, -118.4717975 | Santa Monica-UCLA Medical Center | Santa Monica | California | 90404 | Recruiting | |
Geolocation is 27.3086034, -82.5239953 | Gene E. Myers Cardiac and Vascular Consultants | Sarasota | Florida | 34239 | Recruiting | |
Geolocation is 42.4883003, -71.2015991 | Lahey Clinic Hospital | Burlington | Massachusetts | 01805 | Recruiting | |
Geolocation is 42.9334868, -78.8439268 | University of Buffalo | Buffalo | New York | 14214 | Recruiting | |
Geolocation is 32.785895, -79.9479496 | Medical University of South Carolina | Charleston | South Carolina | 29425 | Recruiting | |
Geolocation is 40.7834328, -111.7376178 | University of Utah | Salt Lake City | Utah | 84108 | Recruiting |
Lead Sponsor:
| Agency |
|---|
University of California, Los Angeles |
Collaborator Sponsor:
| Agency |
|---|
Centers for Medicare and Medicaid Services |
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Daniel H. Silverman, MD, PhD | Principal Investigator | University of California, Los Angeles |
Study Contact:
| Name | Phone | |
|---|---|---|
Cheri L. Geist | 310-794-5067 |
Locations
ClinicalTrials.gov ID
NCT00329706 (follow link to view full record on ct.gov in new window)
Official Title:
Early and Long-Term Value of Imaging Brain Metabolism
Study Start Date:
June 2006
Study End Date:
January 2016
Disease Stage:
Early
Enrollment:
710
