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

Stopped early · Not applicable

Conditions studied: Mild Cognitive Impairment

In brief

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).

Key facts

Study ID

NCT00595582

Run by

Louisiana State University Health Sciences Center Shreveport

People needed

10

Starts

2005-05-01

Expected to finish

2008-06-01

Last updated by the study team

2012-05-28

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: accepted.

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.
• 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:
• 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.
• Positive for the ApoE4 genetic marker through blood test, or meet all other inclusion/exclusion criteria without exception.
• Age: 55-85.
• Normal or clinically unimportant physical exam
• Able to give informed consent/assent
• If you take medications that have an effect on the brain, they will be closely monitored. You will be PET-scanned only after a 24-hour washout of this medication(s), but this medication(s) will be restarted immediately after the scan.
• Mild Alzheimer's Disease (AD) Exclusion Criteria:
• Any problems related to the brain or mental disorders other than mild AD.
• You will get an MRI of your brain taken on the second visit, and a radiologist will read it. If there are any abnormal findings, you will be told, and these findings will be forwarded to your medical doctor. These findings may or may not result in your exclusion from the study.
• Any major medical illness
• Any disease, combination of disease, or presentation that, in the clinician's judgment, could introduce intolerable variance into the PET brain scan image.
• Current diagnosis of substance or alcohol dependence or a history of same and no alcohol or substance abuse within the last eight weeks.
• MCI Inclusion criteria (controls)

Where it is running

• Louisiana State University Health Sciences Center — Shreveport, Louisiana, United States

Full record on ClinicalTrials.gov

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