Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)

Description

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.

Study Start Date

June 2006

Estimated Completion Date

January 2017

Interventions

  • Procedure: FDG-PET brain scan

Specialties

  • Neurology: Dementia,Neuroradiology
  • Radiology: CT/SPECT/PET,Neuroradiology
  • Physician Assistant: Neurology,Radiology

MeSH Terms

  • Dementia
  • FDG-PET brain scan

Study ID

University of California, Los Angeles -- 02-10-079, 03-04-026

Status

Unknown

Trial ID

NCT00329706

Study Type

Interventional

Trial Phase

N/A

Enrollment Quota

710

Sponsor

University of California, Los Angeles

Inclusion Criteria

  • Cognitive deficit and/or personality change is present, as observable by physician and/or close contact(s) of the patient
  • or in the absence of this, the patient provides a clear history of decline which the patient's physician deems to be reliable.
  • If history or neurologic exam reveals findings suspicious for stroke, tumor, bleed, ictal activity, or hydrocephalus, then CT/MRI and appropriate neurological or neurosurgical consultation must have been obtained.
  • Standard history, physical, and laboratory screen have been performed to identify possible presence 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.
  • Any positive findings revealed in 2) or 3) above have been appropriately treated, wherever possible, but cognitive/behavioral deficit persists post-therapy.

Exclusion Criteria

  • Subjects under age 65 will not be recruited, in order to enhance the clinical relevance of the project by focusing on the age groups in whom serious concerns about early signs and symptoms of senile onset dementia are most typically emerging.
  • Overt dementia, as discussed above.
  • Cognitive dysfunction has impaired subject's ability to perform activities of daily living.
  • Present or past history of thyroid disease (due to effects of both the disease and thyroid hormone replacement therapy on brain metabolism that we and others have begun to identify, but which remain incompletely characterized.)
  • Claustrophobia or metal in body or other condition that would preclude PET or MRI from being acquired, or visual, auditory or motor deficits that would preclude accurate neuropsychological testing.
  • Cholinesterase inhibition therapy already initiated.

Gender

Both

Ages

65 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (11)

Study Location Distance Name Phone Email
Lahey Clinic Hospital - Burlington, Massachusetts 11.0 miles None None None
University of Buffalo - Buffalo, New York 395.9 miles None None None
Medical University of South Carolina - Charleston, South Carolina 821.2 miles None None None
Gene E Myers Cardiac and Vascular Consultants - Sarasota, Florida 1,225.8 miles None None None
University of Utah - Salt Lake City, Utah 2,093.0 miles None None None
University of Utah - Salt Lake City, Utah 2,093.0 miles None None None
Mayo Clinic - Phoenix, Arizona 2,284.5 miles None None None
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles Grace Ih Site Coordinator 310-423-7546 Grace.Ih@cshs.org
CedarsSinai Medical Center - Los Angeles, California 2,601.4 miles None None None
Santa MonicaUCLA Medical Center - Santa Monica, California 2,607.9 miles Cheri L Geist Coordinator 310-794-5067 CGeist@mednet.ucla.edu
Santa MonicaUCLA Medical Center - Santa Monica, California 2,607.9 miles None None None

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