Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training

NCT ID: NCT03503669

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2021-02-01

Brief Summary

The purpose of this pilot study will be to test whether Kundalini yoga (KY) and Kirtan Kriya (KK) yogic meditation is superior to Memory Enhancement Training (MET) for improving cognitive functioning, health (including cardiovascular factors), and mood in women with high AD risk.

Detailed Description

Overall, the investigators anticipate recruiting 100 women (50 or older) with MCI and high Alzheimer's disease risk. Subjects will either receive: (1) MET class for 60 minutes per week; or (2) Kundalini yoga and "Kirtan Kriya" meditation class for 60 minutes per week. Assessments will be completed immediately after the interventions at 6 and 12 weeks and follow-up visits at week 24 and 48 to monitor the overall benefit of the intervention.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Memory Training

Group memory training will be administered for amnestic mild cognitive impairment (MCI)

Group Type: ACTIVE_COMPARATOR

Memory Training

Intervention Type: BEHAVIORAL

Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.

Kundalini yoga and meditation

Participants will engage in weekly yoga classes and daily 12 minute meditation

Group Type: EXPERIMENTAL

Kundalini yoga and meditation

Intervention Type: BEHAVIORAL

Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.

Interventions

Memory Training

Participants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.

Intervention Type: BEHAVIORAL

Kundalini yoga and meditation

Participants will participate in a 60 minute yoga and meditation session weekly for 12 weeks and will be assigned a daily Kirtan Kriya meditation (12 minute duration) for 12 weeks.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5.

2. High cardiovascular risk defined as at least one of the following:

• 7.5 percentile risk or higher using ASCVD risk calculator
• Myocardial Infarction more than 6 months ago
• Diabetes
• Taking medication for blood pressure > 140/90 blood pressure
• Taking medication for lyperlipidemia LDL >160

3. Sufficient English proficiency and the 8th grade or higher reading level as determined by the word reading subtest of the Wide Range Achievement Test-IV (this criterion is necessary in order to ensure ability to participate in MET, which involves reading and writing and has a Flesch-Kinkaid school equivalency of 7th grade)

4. Capacity to provide informed consent

Exclusion Criteria

1. History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder

2. Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition

3. Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)

4. Insufficient English proficiency to participate in either MET or KK+KY

5. Diagnosis of dementia

6. Mini Mental Health Examination score of 23 or below

7. Currently taking any psychoactive medication

8. Participation in a psychotherapy that involves cognitive training

9. Practice of Kundalini Yoga or Kirtan Kriya within the past year

10. Myocardial Infarction within the past 6 months

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

Sponsors

Alzheimer's Research and Prevention Foundation

OTHER

Sponsor Role: collaborator

University of California, Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

Helen Lavretsky, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Helen Lavretsky, MS, MD

Role: PRINCIPAL_INVESTIGATOR

UCLA Semel Institute

Locations

UCLA Semel Institute

Los Angeles, California, United States

Countries

United States

References

Krause-Sorio B, Siddarth P, Kilpatrick L, Milillo MM, Aguilar-Faustino Y, Ercoli L, Narr KL, Khalsa DS, Lavretsky H. Yoga Prevents Gray Matter Atrophy in Women at Risk for Alzheimer's Disease: A Randomized Controlled Trial. J Alzheimers Dis. 2022;87(2):569-581. doi: 10.3233/JAD-215563.

Reference Type: RESULT

PMID: 35275541 (View on PubMed)

Grzenda A, Siddarth P, Milillo MM, Aguilar-Faustino Y, Khalsa DS, Lavretsky H. Cognitive and immunological effects of yoga compared to memory training in older women at risk for alzheimer's disease. Transl Psychiatry. 2024 Feb 14;14(1):96. doi: 10.1038/s41398-024-02807-0.

Reference Type: DERIVED

PMID: 38355715 (View on PubMed)

Kilpatrick LA, Siddarth P, Krause-Sorio B, Milillo MM, Aguilar-Faustino Y, Ercoli L, Narr KL, Khalsa DS, Lavretsky H. Impact of Yoga Versus Memory Enhancement Training on Hippocampal Connectivity in Older Women at Risk for Alzheimer's Disease. J Alzheimers Dis. 2023;95(1):149-159. doi: 10.3233/JAD-221159.

Reference Type: DERIVED

PMID: 37482992 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

17-001876

Identifier Type: -

Identifier Source: org_study_id