Curcumin and Yoga Therapy for Those at Risk for Alzheimer's Disease
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ClinicalTrials.gov Identifier: NCT01811381 |
Recruitment Status : Unknown
Verified September 2020 by VA Office of Research and Development.
Recruitment status was: Active, not recruiting
First Posted : March 14, 2013
Last Update Posted : September 17, 2020
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Condition or disease | Intervention/treatment | Phase |
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Mild Cognitive Impairment | Drug: Curcumin Behavioral: aerobic yoga Behavioral: non aerobic yoga Dietary Supplement: Placebo | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | Curcumin and Yoga Exercise Effects in Veterans at Risk for Alzheimer's Disease |
Actual Study Start Date : | January 20, 2014 |
Actual Primary Completion Date : | March 16, 2020 |
Estimated Study Completion Date : | December 31, 2020 |

Arm | Intervention/treatment |
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Experimental: Curcumin and aerobic exercise
For the first 6 months of the study, subjects will take 800 mg of curcumin (4 capsules x BID, p.o.) before meals. From six to 12 months after the beginning of the study, subjects will take curcumin (4 capsules BID before meals, total 800 mg/day) and also participate in an aerobic yoga exercise program (Attendance at 2 classes of 1 hour duration [or 1 hr SecureVideo Live videoconference remote classes for subject who become proficient] and 2 home practices of 30 minute duration per week).
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Drug: Curcumin
Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals
Other Name: Longvida Curcumin (Verdure Sciences, Indianapolis) Behavioral: aerobic yoga Each week, subjects will attend two one hour aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute aerobic yoga practice sessions at home. If proficient, subjects will take a live-video conference remote class, HIPAA approved SecureVideo classes. Modification of consent has been approved. |
Placebo Comparator: Placebo vs non-aerobic yoga
For the first 6 months of the study, subjects will take Placebo (4 capsules x BID, p.o.) before meals. From six months to 12 months from the beginning of the study, subjects will take Placebo (4 capsules x BID) and participate in a weekly non-aerobic yoga program (Attendance at 2 classes of 1 hour duration or 1 hr SecureVideo Live videoconference remote classes for subject who become proficient] and 2 home practices of 30 minute duration per week).
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Behavioral: non aerobic yoga
Subjects will take two non-aerobic (stretching) classes weekly as well as practice two 30 minutes yoga routines at home weekly. Each week, subjects will attend two one hour non-aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute non-aerobic yoga practice sessions at home. Dietary Supplement: Placebo Subjects will take 4 capsules x BID of placebo |
Active Comparator: Placebo vs Aerobic Yoga
For the first 6 months of the study, subjects will take Placebo (4 capsules x BID, p.o.) before meals. From six months to 12 months from the beginning of the study, subjects will take Placebo (4 capsules x BID) and participate in a weekly aerobic yoga program (Attendance at 2 classes of 1 hour duration [or 1 hr SecureVideo Live videoconference remote classes for subject who become proficient] and 2 home practices of 30 minute duration per week).
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Behavioral: aerobic yoga
Each week, subjects will attend two one hour aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute aerobic yoga practice sessions at home. If proficient, subjects will take a live-video conference remote class, HIPAA approved SecureVideo classes. Modification of consent has been approved. Dietary Supplement: Placebo Subjects will take 4 capsules x BID of placebo |
Active Comparator: Curcumin vs non aerobic yoga
For the first 6 months of the study, subjects will take 800 mg of curcumin (4 capsules x BID, p.o.) before meals. From six months to 12 months from the beginning of the study, subjects will take Curcumin (4 capsules x BID, total 800 mg/day) and participate in a weekly non-aerobic yoga program (Attendance at 2 classes of 1 hour duration [or 1 hr SecureVideo Live videoconference remote classes for subject who become proficient] and 2 home practices of 30 minute duration per week).
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Drug: Curcumin
Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals
Other Name: Longvida Curcumin (Verdure Sciences, Indianapolis) Behavioral: aerobic yoga Each week, subjects will attend two one hour aerobic yoga classes under the supervision of certified yoga instructors and complete two 30 minute aerobic yoga practice sessions at home. If proficient, subjects will take a live-video conference remote class, HIPAA approved SecureVideo classes. Modification of consent has been approved. |
- Curcumin effects (first six month period) or curcumin and aerobic yoga effects (second six month period) on the changes in the levels of blood biomarkers for Mild Cognitive Impairment relative to baseline or relative to placebo or non-aerobic yoga. [ Time Frame: 0, 6, and 12 months ]Blood samples at baseline & follow-ups are collected & analyzed for changes in biomarkers associated with MCI and/or curcumin: Clusterin, C-reactive protein, N-terminal prohormone of brain natriuretic peptide, Apolipoprotein E, beta-amyloid, vascular cell adhesion molecule protein-1, Brain derived neurotrophic factor, Interleukin-6, Interleukin-1 beta, Interleukin 1 receptor accessory protein-like 2, Tumor necrosis factor alpha, Osteopontin. The investigators will test whether supplements and/or exercise type are associated with a decrease in the biomarkers thought to be associated with MCI
- Changes in 18F-fluorodeoxyglucose (FDG) Positron Emission Tomography (PET) glucose metabolism neuroimaging after supplementation compared to baseline and compared to placebo [ Time Frame: 0 and 6 months ]Functional connectivity multivariate discriminant analysis of neuroimaging changes using 18FDG-PET predicting rapid conversion to Alzheimer will be examined in subjects on supplements compared to those on placebo. Cerebral metabolism of glucose will be assessed for those receiving supplements vs. placebo and vs baseline (first six months).
- Curcumin effects on changes in Neuropsychological parameters compared to baseline and to placebo (first six month period) and in combination with aerobic yoga, compared to baseline and to non-aerobic yoga with curcumin or aerobic yoga with supplement [ Time Frame: 0, 6, 12 months ]Cognitive changes shown to precede Alzheimer's will be assessed using a neuropsychological battery. Behavioral symptoms will be assessed with the Neuropsychiatric Inventory Questionnaire (NPI-Q). Instrumental activities of daily living will be assessed with the Functional Activities Questionnaire. Overall assessment of disease severity will be assessed with the Clinical Dementia Rating Scale Sum of Boxes. subjects on supplements compared to those on placebo. Neuropsychiatric parameters will be assessed for those receiving supplements vs baseline or vs placebo or with those performing aerobic yoga with placebo or non aerobic yoga with curcumin (second six month period).
- Number of Participants with Adverse Events [ Time Frame: 0,3,6,9,12 months ]The investigators will perform routine comprehensive blood panel test to monitor safety and tolerability of Curcumin in subjects at risk for MCI by means of adverse events, vital signs and safety laboratory assessments. [ Time Frame: is at each timepoint in the study, 3, 6, 9 and 12 months].

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Ages Eligible for Study: | 50 Years to 90 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Gender Based Eligibility: | Yes |
Gender Eligibility Description: | Female subjects have the same inclusion and exclusion criteria as men. Although males have increased representation in the veteran population, which is prioritized, we make efforts to recruit females through the LA times. |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- age between 50 and 90 years;
- Mini-Mental Status Exam (MMSE) scores greater than 24;
- subjective cognitive complaints based on subjective cognitive impairment questionaire (Gifford et al. 2015) including non-amnestic or amnestic cognitive deficits MCI (performance 1.5 standard deviation (SD) below normative means on The Consortium to Establish a Registry for Alzheimer's Disease (CERAD) word list learning test);
- essentially intact activities of daily living (FAQ scores < 6);
- Sedentary (exercise < 30 minutes a day, 3 times a week);
- ambulatory, able exercise safely without cardiovascular symptoms, and able to pass a graded treadmill test modified for the elderly;
- able to arrange transportation to the study;
- Willing and intellectually able to understand and to sign an informed consent and to adhere to protocol requirements;
- community dwelling; and
- fluent in written and spoken English
- must screen positive for a Modified abbreviated MCI or SCD screen on phone, before coming in to clinic for extensive testing
Exclusion Criteria:
- diagnosis of dementia,
- concurrent substance abuse disorder,
- psychosis or mood disorder,
- neurological disease affecting motor or cognitive abilities (e.g. Parkinson's disease),or other significant uncontrolled medical problems,
- cannot get up and down from floor
- initiation of any new medications/treatment for cognitive impairment (i.e. cholinesterase inhibitor, memantine) < 6 months prior to study enrollment

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01811381
United States, California | |
VA Greater Los Angeles Healthcare System, West Los Angeles, CA | |
West Los Angeles, California, United States, 90073 |
Principal Investigator: | Sally A Frautschy, PhD | VA Greater Los Angeles Healthcare System, West Los Angeles, CA |
Publications:
Responsible Party: | VA Office of Research and Development |
ClinicalTrials.gov Identifier: | NCT01811381 |
Other Study ID Numbers: |
E0669-I VA_RX00069 ( Other Grant/Funding Number: Veterans Affairs ) |
First Posted: | March 14, 2013 Key Record Dates |
Last Update Posted: | September 17, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Supporting Materials: |
Study Protocol Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | January 1, 2020 is our deadline to published the data. |
Access Criteria: | we will share data in a publication (biomarker data, curcumin pharmacokinetics, cognitive and neuroimaging changes). we may also provide RNAseq data on exosomes. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
Alzheimer Prevention mild cognitive impairment physical exercise synergism curcumin |
dietary supplement anti-inflammatory anti-tau subjective memory complaints without MCI plasma-exosomes plasm- extracellular-derived-vesicles |
Alzheimer Disease Cognitive Dysfunction Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Cognition Disorders Curcumin |
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