Clinical trial NCT03503669: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Keywords: Memory impairment
Meditation
Yoga
Memory Training
Mild Cognitive Impairment
MCI
Geriatric
fMRI
Alzheimer's disease
Cardiovascular risk
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
Collaborators: name: Alzheimer's Research and Prevention Foundation
First posted: 2018-04-20
Enrollment: 100
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score
timeFrame: Measured at Baseline and Week 24
measure: Change in Delayed Recall Cognitive Domain Scores
timeFrame: Measured at Baseline and Week 24
measure: Change in Executive Function Cognitive Domain Scores
timeFrame: Measured at Baseline and Week 24
Secondary outcomes:
measure: Change in Memory Functioning Questionnaire (MFQ) Scale
timeFrame: Measured at Baseline and Week 24, change from baseline to week 24 is reported.
measure: Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)
timeFrame: Measured at Baseline and Week 24, change from baseline to week 24 is reported.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Semel Institute
state: California
Study officials:
affiliation: UCLA Semel Institute
name: Helen Lavretsky, MS, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.