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

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.

Study Overview

• Status: Completed
• Conditions: Mild Cognitive Impairment; Alzheimer's Disease
• Intervention / Treatment: Behavioral: Memory Training; Behavioral: Kundalini yoga and meditation

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • UCLA Semel Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Memory Training; Group memory training will be administered for amnestic mild cognitive impairment (MCI)	Behavioral: 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.
Experimental: Kundalini yoga and meditation; Participants will engage in weekly yoga classes and daily 12 minute meditation	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Memory Functioning Questionnaire (MFQ) Scale	Secondary outcome measures included the Memory Functioning Questionnaire (MFQ), a self-assessment scale. The MFQ is a scale that assesses subjective memory complaints. We will use the following MFQ subscales: General Frequency of Forgetting (MFQ factor 1), Seriousness of Forgetting (MFQ factor 2), and Retrospective Functions (MSQ factor 3). Each item is scored from 1 to 7 with higher scores indicating a higher level of perceived memory functioning. MSQ factor 1 (33 items) ranges from 7 to 231, MFQ factor 2 (18 items) ranges from 7-126 and MSQ factor 3 (5 items) ranges from 7 to 35.	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)	Health-Related quality of life will be determined using the Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) which comprises 8 scales: physical functioning, role limitations - physical, role limitations - emotional, energy, emotional well-being, social functioning, pain, and general health. Scales are scored from 0 to 100 with higher scores indicating higher quality of life.	Measured at Baseline and Week 24, change from baseline to week 24 is reported.

Collaborators and Investigators

• Sponsor: University of California, Los Angeles
• Collaborators: Alzheimer's Research and Prevention Foundation (ARPF)
• Investigators: Principal Investigator: Helen Lavretsky, MS, MD, UCLA Semel Institute

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): January 8, 2021
• Study Completion (Actual): February 1, 2021

Study Registration Dates

• First Submitted: April 11, 2018
• First Submitted That Met QC Criteria: April 18, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Yoga; Alzheimer's disease; Mild Cognitive Impairment; MCI; fMRI; Meditation; Cardiovascular risk; Memory impairment; Geriatric; Memory Training
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Cognition Disorders; Alzheimer Disease; Cognitive Dysfunction
• Other Study ID Numbers: 17-001876

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No