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NCT01383161 · ClinicalTrials.gov registry record · Phase 2
18-Month Study of Memory Effects of Curcumin
A Phase 2 study, sponsored by University of California, Los Angeles.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT01383161 is a Phase 2 study that has completed, run by University of California, Los Angeles. The registered enrollment target is 46 participants.
The verdict
NCT01383161, a Phase 2 study, has completed, sponsored by University of California, Los Angeles.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study Summary
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 twice daily or the curcumin supplement (Theracurmin®, containing 90 mg of curcumin). The investigators expect that the volunteers receiving the curcumin supplement will show less evidence of decline after 18 months than those receiving the placebo. The investigators predict that cognitive decline and treatment response will vary according to genetic risk for Alzheimer's. The investigators will study 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 a diagnosis of MCI or normal aging. Once enrolled, subjects will begin taking the supplement (either curcumin or a placebo). Some of the initial subjects will be asked to return every three months for regular MRIs. Every 6 months, subjects will also receive 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 cognitive 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
Interventions
- OTHER Placebo
- DRUG Curcumin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2012-03 |
| Est. Completion | 2017-04 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383161
The ClinicalTrials.gov registry entry for NCT01383161 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Los Angeles, which has 897 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01383161 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01383161 about?
NCT01383161 is a clinical study titled "18-Month Study of Memory Effects of Curcumin". 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...
What is the current status of trial NCT01383161?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2012-03. Estimated completion is 2017-04.
What interventions are being tested in trial NCT01383161?
The interventions under investigation include: Placebo (OTHER), Curcumin (DRUG).
Who is sponsoring clinical trial NCT01383161?
This trial is sponsored by University of California, Los Angeles, which has 897 total clinical trials registered on ClinicalTrials.gov.
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