Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)

NCT00329706 | Completed DMC

• 1 other identifier: 02-10-079, 03-04-026
• Study Type: interventional
• Target: 710
• Locations: 1 country
• Sites: 9

Brief Summary

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.

Conditions

Dementia

Keywords

mild cognitive impairment; Alzheimer's disease; dementia; FDG; PET

Outcome Measures

Primary Outcomes (4)

• change from baseline in neuropsychological (cognitive,functional) test results

  baseline and 2 years

• utilization of healthcare resources

  baseline and 2 years

• PET results, compared with working diagnoses made before and after time of PET

  baseline and up to 2 years

• rates of prescription of AD-specific therapies

  baseline and 2 years

Study Arms (2)

1

EXPERIMENTAL

Experimental arm will have an immediate release of the PET report

Procedure: FDG-PET brain scan

2

ACTIVE COMPARATOR

Active Comparator arm will have a delayed release of 2 years

Procedure: FDG-PET brain scan

Interventions

FDG-PET brain scan PROCEDURE

The difference in the two arms' interventions is the time at which the FDG-PET brain scan information is available for the subjects' managing physicians. Experimental arms will have an immediate release of the PET report, while the Active Comparator arms will have a delayed release of 2 years.

Also known as: [F-18]FDG PET brain scan administered once to both arms

1; 2

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Centers for Medicare and Medicaid Services: collaborator

Study Sites (9)

Mayo Clinic

Phoenix, Arizona, 85054, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

UCLA Medical Center

Los Angeles, California, 90095-6942, United States

Location

Santa Monica-UCLA Medical Center

Santa Monica, California, 90404, United States

Location

Gene E. Myers Cardiac and Vascular Consultants

Sarasota, Florida, 34239, United States

Location

Lahey Clinic Hospital

Burlington, Massachusetts, 01805, United States

Location

University of Buffalo

Buffalo, New York, 14214, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

MeSH Terms

Conditions

Dementia; Cognitive Dysfunction; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Cognition Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Daniel H Silverman, MD, PhD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Medical and Molecular Pharmacology

Study Record Dates

• First Submitted: May 24, 2006
• First Posted: May 25, 2006
• Study Start: June 1, 2006
• Primary Completion: January 1, 2017
• Study Completion: January 1, 2017
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

US (9)