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

• Sponsor: University of California, Los Angeles (Other)
• Overall Status: Completed
• CT.gov ID: NCT03503669
• Collaborator: Alzheimer's Research and Prevention Foundation (Other)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 33.1
• Patients Per Site Per Month: 3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Mild Cognitive Impairment; Alzheimer's Disease	Behavioral: Memory Training; Behavioral: Kundalini yoga and meditation	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Supportive Care
• Official Title: Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Jan 8, 2021
• Actual Study Completion Date: Feb 1, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Change in Hopkins Verbal Learning Test (HVLT) total recall score [Measured at Baseline and Week 24]

   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.

Secondary Outcome Measures

1. Change in Memory Functioning Questionnaire (MFQ) Scale [Measured at Baseline, Week 12, Week 24]

   Secondary outcome measures included the Memory Functioning Questionnaire (MFQ), a self-assessment scale. The MFQ is a scale that assess subjective memory complaints. We will use the following MFQ subscales: General Frequency of Forgetting, Seriousness of Forgetting, and Retrospective Functions. Each item is scored from 1 to 7 with higher scores indicate higher level of perceived memory functioning. General frequency of forgetting (33 items) ranges from 7 to 231, Seriousness of Forgetting (18 items) ranges from 7-126 and Retrospective Functions (5 items) ranges from 7 to 35.

2. Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) [Measured at Baseline, Week 12, Week 24]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 90 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

1. 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)

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UCLA Semel Institute	Los Angeles	California	United States	90095

Sponsors and Collaborators

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

Investigators

• Principal Investigator: Helen Lavretsky, MS, MD, UCLA Semel Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Helen Lavretsky, MD, Professor, University of California, Los Angeles
• ClinicalTrials.gov Identifier: NCT03503669
• Other Study ID Numbers: 17-001876
• First Posted: Apr 20, 2018
• Last Update Posted: Mar 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Helen Lavretsky, MD, Professor, University of California, Los Angeles: Memory impairment; Meditation; Yoga; Memory Training; Mild Cognitive Impairment; MCI; Geriatric; fMRI; Alzheimer's disease; Cardiovascular risk
• Additional relevant MeSH terms: Alzheimer Disease; Cognitive Dysfunction

Study Results

No Results Posted as of Mar 2, 2022