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

NCT03503669 | Completed Results

• 1 other identifier: 17-001876
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Cognitive Impairment; Alzheimer's Disease

Keywords

Memory impairment; Meditation; Yoga; Memory Training; Mild Cognitive Impairment; MCI; Geriatric; fMRI; Alzheimer's disease; Cardiovascular risk

Outcome Measures

Primary Outcomes (3)

• Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score

  Verbal memory was measured with the Hopkins Verbal Learning Test (HVLT) total recall scores. The HVLT form contains 12 nouns, four words each from one of three semantic categories (e.g., precious gems, articles of clothing, vegetables, etc.), to be learned over the course of three learning trials. When scoring the HVLT, the three learning trials are combined to calculate a total recall score. Total scores range from 0-36 with higher scores indicating better outcome.

  Measured at Baseline and Week 24

• Change in Delayed Recall Cognitive Domain Scores

  Delayed Recall Cognitive Domain score was constructed from: HVLT Delayed Recall, Rey-Osterrieth Complex Figure Test \[30-minute Delayed Recall\], WMS-IV Logical Memory II Delayed Recall. Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. A z-score of 0 represents the sample mean. These z-scores were then averaged to produce a Delayed Recall Cognitive Domain score. Higher Delayed Recall Cognitive Domain scores are indicative of better performance.

  Measured at Baseline and Week 24

• Change in Executive Function Cognitive Domain Scores

  Executive Function Cognitive Domain score was constructed from: Trail Making Test A and B, Stroop Interference \[Golden version\] and FAS. Raw scores were transformed to z-scores (with a mean of 0 and standard deviation of 1) for each test score of interest across all participants. A z-score of 0 represents the sample mean. These z-scores were then averaged to produce an Executive Function Cognitive Domain score. Higher Executive Function Cognitive Domain scores are indicative of better performance.

  Measured at Baseline and Week 24

Secondary Outcomes (2)

• Change in Memory Functioning Questionnaire (MFQ) Scale

  Measured at Baseline and Week 24, change from baseline to week 24 is reported.

• Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)

  Measured at Baseline and Week 24, change from baseline to week 24 is reported.

Study Arms (2)

Memory Training

ACTIVE COMPARATOR

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

Behavioral: Memory Training

Kundalini yoga and meditation

EXPERIMENTAL

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

Behavioral: Kundalini yoga and meditation

Interventions

Memory Training 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.

Memory Training

Kundalini yoga and meditation 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.

Kundalini yoga and meditation

Eligibility Criteria

• Age: 50 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5.
• High cardiovascular risk defined as at least one of the following:
• 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
• 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)
• Capacity to provide informed consent

You may not qualify if:

• History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder
• Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition
• Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)
• Insufficient English proficiency to participate in either MET or KK+KY
• Diagnosis of dementia
• Mini Mental Health Examination score of 23 or below
• Currently taking any psychoactive medication
• Participation in a psychotherapy that involves cognitive training
• Practice of Kundalini Yoga or Kirtan Kriya within the past year
• Myocardial Infarction within the past 6 months

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Alzheimer's Research and Prevention Foundation: collaborator

Study Sites (1)

UCLA Semel Institute

Los Angeles, California, 90095, United States

Location

Related Publications (3)

• 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.

  PMID: 35275541 RESULT

• 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.

  PMID: 38355715 DERIVED

• 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.

  PMID: 37482992 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Memory Disorders

Interventions

Cognitive Training; Meditation

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Mind-Body Therapies; Complementary Therapies; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Limitations and Caveats

After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.

Results Point of Contact

• Title: Helen Lavretsky, MD
• Organization: University of California, Los Angeles

HLavretsky@mednet.ucla.edu

(310) 794-4619

Study Officials

• Helen Lavretsky, MS, MD

  UCLA Semel Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 11, 2018
• First Posted: April 20, 2018
• Study Start: May 1, 2018
• Primary Completion: January 8, 2021
• Study Completion: February 1, 2021
• Last Updated: February 8, 2024
• Results First Posted: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)