Mild Cognitive Impairment
Conditions
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.
Interventions
DIETARY_SUPPLEMENTcurcumin + 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.
Sponsors
Louisiana State University Health Sciences Center Shreveport
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
Yes
Inclusion criteria
MCI 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, * Able to give informed consent, or assent * MRI findings must be normal or unremarkable for the age of the patient.
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 20. * You must have one or more of these signs and symptoms of mild AD all of which impair function and are worsening over time: 1. Cognitive impairment manifested as memory problems 2. problems with language 3. difficulty carrying out motor activities 4. difficulty naming things 5. problems planning or organizing * You must have at least 10 years of education, or a GED, or its equivalent. * Positive for the ApoE4 genetic marker through blood test, or meet all other inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neuropsychological Scores in Patients With MCI or Mild AD. | within the next three years |
Countries
United States
Participant flow
Recruitment details
Subjects were initially recruited for an MCI study which was IRB approved 9-29-03 and subjects were recruited from a medical clinic and advertising.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| Total | 10 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Physician Decision | 5 |
| Overall Study | Pilot study that PI terminated | 2 |
Baseline characteristics
| Characteristic | Curcumin + Bioperine |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 10 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age Continuous | 77.6 years STANDARD_DEVIATION 5.83476 |
| Region of Enrollment United States | 10.0 participants |
| Sex: Female, Male Female | 7.0 Participants |
| Sex: Female, Male Male | 3.0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 2 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Neuropsychological Scores in Patients With MCI or Mild AD.
Time frame: within the next three years
Population: No data were collected as this study was terminated.