Mild Cognitive Impairment Clinical Trial
Official title:
Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine
This is an additional study to the primary Mild Cognitive Impairment (MCI) study (LSU#H04-049; NCT00243451)that is underway of PET detection of Mild Cognitive Impairment. This study has preliminary data that indicates objective analysis of PET brain image metabolic data is a sensitive marker for AD. The goal of this proposal is to determine the efficacy of curcumin in the treatment of MCI or mild Alzheimer's Disease (AD).
The specific aims of this study include:
- Determine if curcumin has an effect on neuropsychological scores in patients with MCI.
Working Hypothesis: Patients with MCI that have evidence of objective memory impairment
will have improvement on neuropsychological test scores.
- Determine if curcumin impacts the metabolic lesions found in patients who have MCI or
may develop MCI. Working hypothesis: The metabolic lesions present that are consistent
with the development of early AD will improve with curcumin treatment.
Patients diagnosed with MCI, patients who have metabolic lesions consistent with premorbid
MCI, or mild AD and are currently enrolled in the primary MCI study (LSU#H04-049;
NCT00243451) will be invited to participate in this clinical trial.
These subjects will be treated with 5.4 grams of curcumin per day (900 mg pills, two pills
3X/day with meals) with the inclusion of bioperine additive (formulated with the curcumin
capsules) to improve bioavailability of the curcumin. Patients will be treated with
curcumin/bioperine for 24 months concordant with the last two years of the three year
longitudinal primary MCI study. Clinical endpoints will be change in neuropsychological
scores, and size of metabolic lesions on the PET scan. Both of these measures will be
recorded as part of the primary MCI study.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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