Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)

• ClinicalTrials.gov Identifier: NCT00329706
• Recruitment Status: Completed
• First Posted: May 25, 2006
• Last Update Posted: May 2, 2017
• Sponsor: University of California, Los Angeles
• Collaborator: Centers for Medicare and Medicaid Services
• Information provided by (Responsible Party): Daniel H. Silverman, University of California, Los Angeles

Tracking Information

• First Submitted Date: May 24, 2006
• First Posted Date: May 25, 2006
• Last Update Posted Date: May 2, 2017
• Study Start Date: June 2006
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 3, 2011)

• change from baseline in neuropsychological (cognitive,functional) test results [ Time Frame: baseline and 2 years ]
• utilization of healthcare resources [ Time Frame: baseline and 2 years ]
• PET results, compared with working diagnoses made before and after time of PET [ Time Frame: baseline and up to 2 years ]
• rates of prescription of AD-specific therapies [ Time Frame: baseline and 2 years ]

Original Primary Outcome Measures (submitted: May 24, 2006)

• PET results compared with early diagnoses, before and after time of PET
• Rates of prescription of AD-specific therapies
• Change from baseline in neuropsychological (cognitive,functional) test results
• Utilization of healthcare resources

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
• Official Title: Early and Long-Term Value of Imaging Brain Metabolism
• 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.

Detailed Description

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).

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Single (Participant); Primary Purpose: Diagnostic
• Condition: Dementia

Intervention

Procedure: FDG-PET brain scan

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.

Other Name: [F-18]FDG PET brain scan administered once to both arms

Study Arms

• Experimental: 1
  Experimental arm will have an immediate release of the PET report
  Intervention: Procedure: FDG-PET brain scan
• Active Comparator: 2
  Active Comparator arm will have a delayed release of 2 years
  Intervention: Procedure: FDG-PET brain scan

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: May 24, 2006): 710
• Original Enrollment: Same as current
• Actual Study Completion Date: January 2017
• Actual Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00329706
• Other Study ID Numbers: 02-10-079, 03-04-026
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Daniel H. Silverman, University of California, Los Angeles
• Original Responsible Party: Not Provided
• Current Study Sponsor: University of California, Los Angeles
• Original Study Sponsor: Same as current
• Collaborators: Centers for Medicare and Medicaid Services

Investigators

• Principal Investigator: Daniel H Silverman, MD, PhD; University of California, Los Angeles

• PRS Account: University of California, Los Angeles
• Verification Date: May 2017