Early Intervention in Mild Cognitive Impairment (MCI) With Curcumin + Bioperine

NCT00595582 | Terminated Results

• 1 other identifier: LSU#H05-168
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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).

Conditions

Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Neuropsychological Scores in Patients With MCI or Mild AD.

  within the next three years

Study Arms (1)

single arm

OTHER

Curcumin + Bioperine

Dietary Supplement: curcumin + bioperine

Interventions

curcumin + bioperine DIETARY_SUPPLEMENT

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.

Also known as: Life Extension Super Bio-Curcumin

single arm

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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:
• Cognitive impairment manifested as memory problems
• problems with language
• difficulty carrying out motor activities
• difficulty naming things
• problems planning or organizing
• You must have at least 10 years of education, or a GED, or its equivalent.
• Age: 55-85.
• Normal or clinically unimportant physical exam
• Able to give informed consent/assent

Sponsors & Collaborators

• Louisiana State University Health Sciences Center Shreveport: lead

Study Sites (1)

Louisiana State University Health Sciences Center

Shreveport, Louisiana, 71103, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Curcumin

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Diarylheptanoids; Heptanes; Alkanes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic

Limitations and Caveats

2 patients withdrew due to Dyspepsia (intolerance to supplement).

Results Point of Contact

• Title: Dr. James Patterson/Professor
• Organization: LSU Health Sciences Center, Shreveport LA

jpatte@lsuhsc.edu

318-813-2070

Study Officials

• James C Patterson, MD, PhD

  LSU Health Sciences Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 4, 2008
• First Posted: January 16, 2008
• Study Start: May 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: May 28, 2012
• Results First Posted: May 28, 2012

Record last verified: 2012-05

Locations

US (1)