Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Mild Cognitive Impairment
- Sponsor
- Louisiana State University Health Sciences Center Shreveport
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Neuropsychological Scores in Patients With MCI or Mild AD.
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief Summary
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).
Detailed Description
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.
Investigators
James C. Patterson, II, MD. Ph
Professor
Louisiana State University Health Sciences Center Shreveport
Eligibility Criteria
Inclusion Criteria
- •MCI criteria met:
- •Memory complaint
- •Objective memory impairment based on test scores
- •Normal general cognitive function.
- •Intact Activities of Daily Living.
- •Not demented.
- •At least 10 years of education, or GED, or equivalent.
- •Patients with ApoE4 positive homozygous or heterozygous status and/or first-degree relative with probable AD are preferred
- •Age: 55-85
- •Have normal or clinically unimportant physical exam,
Exclusion Criteria
- •Other neuropsychiatric diagnoses
- •Major medical illness including potential secondary causes of cognitive decline.
- •Disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image
- •Current substance or alcohol dependence or history of same, and no alcohol or substance abuse within the last eight weeks.
- •Mild Alzheimer's Disease (AD) Inclusion criteria (patients):
- •You must have a Mini Mental State Examination score of greater than
- •You must have one or more of these signs and symptoms of mild AD all of which impair function and are worsening over time:
- •Cognitive impairment manifested as memory problems
- •problems with language
- •difficulty carrying out motor activities
Outcomes
Primary Outcomes
Neuropsychological Scores in Patients With MCI or Mild AD.
Time Frame: within the next three years