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Completed

NCT Number: NCT03503669

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.

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Key information

Conditions

Mild Cognitive Impairment Alzheimer Disease Alzheimer's Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Memory Disorders Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurodegenerative Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Tauopathies

Age range

50 year–90 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

UCLA Semel Institute

Los Angeles, California, 90095, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: 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.

  2. Change in Delayed Recall Cognitive Domain Scores

    Time frame: Measured at Baseline and Week 24

    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.

  3. Change in Executive Function Cognitive Domain Scores

    Time frame: Measured at Baseline and Week 24

    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.

Secondary outcomes

  1. Change in Memory Functioning Questionnaire (MFQ) Scale

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

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

University of California, Los Angeles

Other

Collaborators

  • Alzheimer's Research and Prevention Foundation

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2018
Registry last updated
Feb 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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