Toward clinical trials

Curcumin clinical trials results

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.

The investigators will study 132 subjects with memory complaints aged 50-90 years. Initially, subjects will undergo a clinical assessment, an MRI and a blood draw to determine genetic risk and to rule out other neurodegenerative disorders linked to memory complaints. Subsequently, subjects will undergo an -(1-{6-[(2-[F-18]fluoroethyl)(methyl)amino]-2-naphthyl}ethylidene)malononitrile (FDDNP)PET scan and a baseline neuropsychological assessment to confirm MCI or normal aging diagnosis. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo), and be asked to return every three months for regular MRIs and review sessions. Every 6 months, subjects will also neuropsychological assessments. At the conclusion of the study, subjects will be asked 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 monitor supplement side effects and measure brain structure; the neuropsychological assessments will monitor rates of cognitive decline; the blood draws will be used to test levels of inflammatory markers.

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BMC Medical Research Methodology at the 35th Annual Conference of the ..  — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.

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Popular Q&A

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