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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503669
• Other study ID #: 17-001876
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: February 1, 2021

Study information

• Verified date: February 2024
• Source: University of California, Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2021
• Est. primary completion date: January 8, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	UCLA Semel Institute	Los Angeles	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, Los Angeles	Alzheimer's Research and Prevention Foundation (ARPF)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):56 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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.
Secondary	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.