Curcumin and Yoga Therapy for Those at Risk for Alzheimer's Disease

NCT ID: NCT01811381

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-20
• Study Completion Date: 2020-12-31

Brief Summary

Physical exercise has proven to improve memory including in the elderly. Drugs developed to stop the underlying disease processes that cause Alzheimer's disease may succeed only with multimodal efforts to stimulate brain function. One purpose of the study is to test the clinical benefits of curcumin, a safe and effective compound isolated from the turmeric root (a component of Indian curry spices), which has been found to inhibit several potential disease pathways in Alzheimer's disease. Another purpose of this study is to determine how the addition of a physical exercise program in individuals with early memory problems may affect memory function or brain imaging and blood-based markers associated with Alzheimer's disease.

Detailed Description

Subjects with Mild cognitive impairment (MCI) or Subjective Cognitive Impairment (SCD) are eligible for this study. MCI often represents the earliest stages of Alzheimer's disease (AD), as individuals meeting criteria for MCI are subsequently diagnosed with AD at much higher rates than their cognitively normal elderly peers. Subjects with MCI are at risk of developing AD, within 6 years. Subjects with SCD may be at risk to develop MCI. The study is stratified according to whether subjects have SCD or MCI. The goal of the current study is to determine whether dietary supplementation with a novel formulation of curcumin (a component of the curry spice turmeric), which is better absorbed and more efficiently transported into the brain, can alter biological and clinical markers associated with AD risk, and to determine whether the potential beneficial effects of curcumin supplementation are synergistic with aerobic exercise. The investigators will recruit 80 elderly participants meeting criteria for MCI. Over the second 6 months of the study, the curcumin and placebo groups will be further divided into groups receiving training in either aerobic or non-aerobic yoga to determine the synergism between curcumin supplementation and aerobic exercise. The effectiveness of these interventions will be measured using plasma samples (for expression of Alzheimer-related biomarkers), and neuropsychological, functional, and behavioral assessments (i.e. clinical measures) collected at baseline, 6 months, and 12 months after initiation of treatments, with a subset of participants receiving brain imaging at baseline and 6 months. Dosage is titered up two weeks prior to study start (1 capsule BID, first five days, then 2 capsules BID for five days, then 6 capsules BID for five days, then 8 capsules BID- study dosage). Over the first 6 months of the study, participants will be randomized into equal groups receiving dietary supplementation with either curcumin or placebo. Patients are stratified according to whether they have only subjective memory complaints without MCI versus those that have MCI. Over the second 6 months of the study, participants will be further randomized into equal groups receiving dietary supplementation with either curcumin or placebo.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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).

Group Type: EXPERIMENTAL

Curcumin

Intervention Type: DRUG

Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals

aerobic yoga

Intervention Type: BEHAVIORAL

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 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).

Group Type: PLACEBO_COMPARATOR

non aerobic yoga

Intervention Type: BEHAVIORAL

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.

Placebo

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take 4 capsules x BID of placebo

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).

Group Type: ACTIVE_COMPARATOR

aerobic yoga

Intervention Type: BEHAVIORAL

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

Intervention Type: DIETARY_SUPPLEMENT

Subjects will take 4 capsules x BID of placebo

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).

Group Type: ACTIVE_COMPARATOR

Curcumin

Intervention Type: DRUG

Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals

aerobic yoga

Intervention Type: BEHAVIORAL

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.

Interventions

Curcumin

Subjects will take 800 mg of curcumin in 4 capsules BID per day prior to meals

Intervention Type: DRUG

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Placebo

Subjects will take 4 capsules x BID of placebo

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Longvida Curcumin (Verdure Sciences, Indianapolis)

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sally A Frautschy, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

Locations

VA Greater Los Angeles Healthcare System, West Los Angeles, CA

West Los Angeles, California, United States

Countries

United States

References

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Other Identifiers

VA_RX00069

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E0669-I

Identifier Type: -

Identifier Source: org_study_id