| City: |
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Los Angeles |
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State:
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CA |
| Zip Code: |
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90095 |
| Conditions: |
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Dementia |
| Purpose: |
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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.
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| Study summary: |
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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). |
| Criteria: |
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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. |
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| Study is available at: |
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UCLA Medical Center
Los Angeles, CA 90095
United States
Primary Contact:
Soo K Lee, Coordinator
Email: SKLee@mednet.ucla.edu
Phone: 310-794-5067
Secondary Contact:
Cheri Geist, Central Coordinator
Email: cgeist@mednet.ucla.edu
Phone: 310-794-5067 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 21, 2011 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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