Thursday, June 30, 2011

18-Month Study of Curcumin, Alzheimer's and Genetics, Phase 2 Clinical Trial


Alzheimer's Reading Room

This project is designed to study the effects of the dietary supplement curcumin on age-related cognitive impairment. In particular, the study seeks to determine the effects of curcumin on cognitive decline and the amount of abnormal amyloid protein in the brain. Genetic risk will also be studied as a potential predictor of cognitive decline.

Subjects will be randomly assigned to one of two treatment groups: either a placebo or the curcumin supplement (465 milligrams of Theracurmin™ of which 30 mg is curcumin). The investigators expect the people receiving the curcumin supplement to show less evidence of decline and fewer after 18 months than those receiving the placebo. The investigators believe cognitive decline and treatment response will vary according to a genetic risk for Alzheimer's.

Note: The only available location for this Phase 2 clinical trial is the UCLA Longevity Center, Los Angeles, California, United States, 90024. The study is limited to 132 participants so if you are interested you should make contact now. Gary W Small, M.D., UCLA Semel Institute - Aging and Memory Research Center is the principal investigator.


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The investigators will study 132 subjects with memory complaints aged 50-90 years. Initially, subjects will undergo a clinical assessment, a magnetic resonance imaging (MRI) scan and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo a Fludeoxyglucose F 18 positron emission tomography (FDDNP PET) scan and a baseline neuropsychological assessment to confirm mild cognitive impairment (MCI) or normal aging diagnosis. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo). Subjects will receive a second neuropsychological assessment halfway through the study. At the conclusion of the study, subjects will be asked to return to complete a final neuropsychological assessment, MRI scan, PET scan and blood draw. Additional blood will be drawn at baseline and at 18 months and frozen to assess inflammatory markers if outcomes are positive.

FDDNP-PET scans will be used to measure the amount of abnormal amyloid plaque- and tau tangle- proteins in the brain; the MRIs will be used to measure brain structure; the neuropsychological assessments will monitor rates of cognitive decline; the blood draws will be used to test levels of inflammatory markers.

In addition, subjects will meet with a nutritionist and/or a staff research associate weekly for the first six weeks after their baseline procedures and after beginning to take daily curcumin. Thereafter, monthly contacts will continue to ensure compliance with the study procedures, either in person or by phone or email. Subjects in the curcumin group will learn about nutritional and other lifestyle strategies during these meeting, while the placebo group will receive general health information.

Eligibility

Ages Eligible for Study: 50 Years to 90 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

UCLA Longevity Center

For more detailed information on 18-Month Study of Curcumin go here.




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Original content Bob DeMarco, the Alzheimer's Reading Room