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).
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine|
- Neuropsychological Scores in Patients With MCI or Mild AD. [ Time Frame: within the next three years ] [ Designated as safety issue: No ]
|Study Start Date:||May 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
Curcumin + Bioperine
Dietary Supplement: curcumin + bioperine
Subjects who are currently in the primary Mild Cognitive Impairment study will be asked to be treated with 5.4 grams of curcumin + bioperine per day (900 mg pills, two pills 3x/day with meals) for 24 months concordant with the last two years of the primary longitudinal Mild Cognitive Impairment study.
Other Name: Life Extension Super Bio-Curcumin
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00595582
|United States, Louisiana|
|Louisiana State University Health Sciences Center|
|Shreveport, Louisiana, United States, 71103|
|Principal Investigator:||James C Patterson, MD, PhD||LSU Health Sciences Center|