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

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Memory Training
Kundalini yoga and meditation
Sponsored by
University of California, Los Angeles
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Mild Cognitive Impairment focused on measuring Memory impairment, Meditation, Yoga, Memory Training, Mild Cognitive Impairment, MCI, Geriatric, fMRI, Alzheimer's disease, Cardiovascular risk

Eligibility Criteria

50 Years - 90 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • UCLA Semel Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Memory Training

Kundalini yoga and meditation

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.
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.

Full Information

First Posted
April 11, 2018
Last Updated
February 25, 2022
Sponsor
University of California, Los Angeles
Collaborators
Alzheimer's Research and Prevention Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03503669
Brief Title
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Official Title
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 8, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, Los Angeles
Collaborators
Alzheimer's Research and Prevention Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment, Alzheimer's Disease
Keywords
Memory impairment, Meditation, Yoga, Memory Training, Mild Cognitive Impairment, MCI, Geriatric, fMRI, Alzheimer's disease, Cardiovascular risk

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Training
Arm Type
Active Comparator
Arm Description
Group memory training will be administered for amnestic mild cognitive impairment (MCI)
Arm Title
Kundalini yoga and meditation
Arm Type
Experimental
Arm Description
Participants will engage in weekly yoga classes and daily 12 minute meditation
Intervention Type
Behavioral
Intervention Name(s)
Memory Training
Intervention Description
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
Intervention Name(s)
Kundalini yoga and meditation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hopkins Verbal Learning Test (HVLT) total recall score
Description
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.
Time Frame
Measured at Baseline and Week 24
Secondary Outcome Measure Information:
Title
Change in Memory Functioning Questionnaire (MFQ) Scale
Description
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.
Time Frame
Measured at Baseline, Week 12, Week 24
Title
Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)
Description
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.
Time Frame
Measured at Baseline, Week 12, Week 24

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5. 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 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helen Lavretsky, MS, MD
Organizational Affiliation
UCLA Semel Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA Semel Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35275541
Citation
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.
Results Reference
derived

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

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