Status:
COMPLETED
Metabolic Cerebral Imaging in Incipient Dementia (MCI-ID)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Centers for Medicare and Medicaid Services
Conditions:
Dementia
Eligibility:
All Genders
65+ years
Phase:
NA
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...
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 metabo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
710 Patients enrolled
Trial Details
Trial ID
NCT00329706
Start Date
June 1 2006
End Date
January 1 2017
Last Update
May 2 2017
Active Locations (9)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054
2
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
3
UCLA Medical Center
Los Angeles, California, United States, 90095-6942
4
Santa Monica-UCLA Medical Center
Santa Monica, California, United States, 90404