Alzheimer's Disease, Mild Cognitive Impairment
Conditions
Keywords
Memory impairment, Meditation, Yoga, Memory Training, Mild Cognitive Impairment, MCI, Geriatric, fMRI, Alzheimer's disease, Cardiovascular risk
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.
Interventions
BEHAVIORALMemory 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.
BEHAVIORALKundalini 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.
Sponsors
Alzheimer's Research and Prevention Foundation
University of California, Los Angeles
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to 90 Years
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Change in Delayed Recall Cognitive Domain Scores | 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. |
| Change in Executive Function Cognitive Domain Scores | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Memory Functioning Questionnaire (MFQ) Scale | 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. |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | 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. |
Countries
United States
Participant flow
Pre-assignment details
100 participants were consented and completed screen visit while 79 participants completed baseline and were randomized to either group. 10 individuals were screen fails and 11 dropped out before randomization.
Participants by arm
| Arm | Count |
|---|---|
| Memory Training Group memory training will be administered for amnestic mild cognitive impairment (MCI)
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. | 39 |
| Kundalini Yoga and Meditation Participants will engage in weekly yoga classes and daily 12 minute meditation
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. | 40 |
| Total | 79 |
Baseline characteristics
| Characteristic | Memory Training | Kundalini Yoga and Meditation | Total |
|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 9.3 | 65.5 years STANDARD_DEVIATION 9.1 | 66.48 years STANDARD_DEVIATION 9.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 5 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 36 Participants | 33 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Hopkins Verbal Learning Test (HVLT) | 26.66 units on a scale STANDARD_DEVIATION 5.48 | 28.02 units on a scale STANDARD_DEVIATION 5.29 | 27.34 units on a scale STANDARD_DEVIATION 5.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants | 2 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 4 Participants | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) White | 27 Participants | 32 Participants | 59 Participants |
| Region of Enrollment United States | 39 participants | 40 participants | 79 participants |
| Sex: Female, Male Female | 39 Participants | 40 Participants | 79 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 39 | 0 / 40 |
| other Total, other adverse events | 3 / 39 | 3 / 40 |
| serious Total, serious adverse events | 0 / 39 | 0 / 40 |
Outcome results
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.
Time frame: Measured at Baseline and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory Training | Change in Delayed Recall Cognitive Domain Scores | 0.02 z-score | Standard Deviation 0.55 |
| Kundalini Yoga and Meditation | Change in Delayed Recall Cognitive Domain Scores | -0.31 z-score | Standard Deviation 0.37 |
p-value: 0.008Mixed Models Analysis
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.
Time frame: Measured at Baseline and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory Training | Change in Executive Function Cognitive Domain Scores | -0.03 z-score | Standard Deviation 0.7 |
| Kundalini Yoga and Meditation | Change in Executive Function Cognitive Domain Scores | -0.04 z-score | Standard Deviation 0.42 |
p-value: >0.05Mixed Models Analysis
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.
Time frame: Measured at Baseline and Week 24
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Memory Training | Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score | -0.94 units on a scale | Standard Deviation 5.1 |
| Kundalini Yoga and Meditation | Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score | -1.65 units on a scale | Standard Deviation 6.9 |
p-value: >0.05Mixed Models Analysis
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.
Time frame: Measured at Baseline and Week 24, change from baseline to week 24 is reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Physical Functioning | 0.60 units on a scale | Standard Deviation 26.47 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Role Physical | -15.90 units on a scale | Standard Deviation 40.41 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Role Emotional | -18.18 units on a scale | Standard Deviation 44.16 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Energy | -2.42 units on a scale | Standard Deviation 18.96 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Emotional Wellbeing | 0.72 units on a scale | Standard Deviation 14.01 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Social Functioning | 0 units on a scale | Standard Deviation 24.6 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Pain | -4.92 units on a scale | Standard Deviation 17.35 |
| Memory Training | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | General Health | 1.06 units on a scale | Standard Deviation 13.33 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | General Health | -1.45 units on a scale | Standard Deviation 16.18 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Physical Functioning | 2.70 units on a scale | Standard Deviation 20.48 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Emotional Wellbeing | -3.33 units on a scale | Standard Deviation 19 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Role Physical | 3.12 units on a scale | Standard Deviation 39.91 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Pain | -7.50 units on a scale | Standard Deviation 25.31 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Role Emotional | 2.77 units on a scale | Standard Deviation 46.01 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Social Functioning | -9.89 units on a scale | Standard Deviation 36.29 |
| Kundalini Yoga and Meditation | Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Energy | 0.83 units on a scale | Standard Deviation 18.8 |
p-value: >0.05Mixed Models Analysis
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.
Time frame: Measured at Baseline and Week 24, change from baseline to week 24 is reported.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Memory Training | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 1 | 0.29 units on a scale | Standard Deviation 0.75 |
| Memory Training | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 2 | -0.30 units on a scale | Standard Deviation 1.34 |
| Memory Training | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 3 | 0.51 units on a scale | Standard Deviation 1.58 |
| Kundalini Yoga and Meditation | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 1 | 0.54 units on a scale | Standard Deviation 1.03 |
| Kundalini Yoga and Meditation | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 2 | 0.64 units on a scale | Standard Deviation 1.24 |
| Kundalini Yoga and Meditation | Change in Memory Functioning Questionnaire (MFQ) Scale | MFQ Factor 3 | 0.70 units on a scale | Standard Deviation 1.04 |
p-value: >0.05Mixed Models Analysis