Trial Outcomes & Findings for Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training (NCT NCT03503669)
NCT ID: NCT03503669
Last Updated: 2024-02-08
Results Overview
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.
COMPLETED
NA
100 participants
Measured at Baseline and Week 24
2024-02-08
Participant Flow
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.
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
39
|
40
|
|
Overall Study
COMPLETED
|
37
|
26
|
|
Overall Study
NOT COMPLETED
|
2
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Baseline characteristics by cohort
| Measure |
Memory Training
n=39 Participants
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.
|
Kundalini Yoga and Meditation
n=40 Participants
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.
|
Total
n=79 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
67.5 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
65.5 years
STANDARD_DEVIATION 9.1 • n=7 Participants
|
66.48 years
STANDARD_DEVIATION 9.20 • n=5 Participants
|
|
Sex: Female, Male
Female
|
39 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
79 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
36 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
39 participants
n=5 Participants
|
40 participants
n=7 Participants
|
79 participants
n=5 Participants
|
|
Hopkins Verbal Learning Test (HVLT)
|
26.66 units on a scale
STANDARD_DEVIATION 5.48 • n=5 Participants
|
28.02 units on a scale
STANDARD_DEVIATION 5.29 • n=7 Participants
|
27.34 units on a scale
STANDARD_DEVIATION 5.40 • n=5 Participants
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 24Verbal 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.
Outcome measures
| Measure |
Memory Training
n=37 Participants
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.
|
Kundalini Yoga and Meditation
n=26 Participants
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.
|
|---|---|---|
|
Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score
|
-0.94 units on a scale
Standard Deviation 5.10
|
-1.65 units on a scale
Standard Deviation 6.90
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 24Delayed 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.
Outcome measures
| Measure |
Memory Training
n=37 Participants
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.
|
Kundalini Yoga and Meditation
n=26 Participants
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.
|
|---|---|---|
|
Change in Delayed Recall Cognitive Domain Scores
|
0.02 z-score
Standard Deviation 0.55
|
-0.31 z-score
Standard Deviation 0.37
|
PRIMARY outcome
Timeframe: Measured at Baseline and Week 24Executive 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.
Outcome measures
| Measure |
Memory Training
n=37 Participants
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.
|
Kundalini Yoga and Meditation
n=26 Participants
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.
|
|---|---|---|
|
Change in Executive Function Cognitive Domain Scores
|
-0.03 z-score
Standard Deviation 0.70
|
-0.04 z-score
Standard Deviation 0.42
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Memory Training
n=37 Participants
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.
|
Kundalini Yoga and Meditation
n=26 Participants
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.
|
|---|---|---|
|
Change in Memory Functioning Questionnaire (MFQ) Scale
MFQ Factor 1
|
0.29 units on a scale
Standard Deviation 0.75
|
0.54 units on a scale
Standard Deviation 1.03
|
|
Change in Memory Functioning Questionnaire (MFQ) Scale
MFQ Factor 2
|
-0.30 units on a scale
Standard Deviation 1.34
|
0.64 units on a scale
Standard Deviation 1.24
|
|
Change in Memory Functioning Questionnaire (MFQ) Scale
MFQ Factor 3
|
0.51 units on a scale
Standard Deviation 1.58
|
0.70 units on a scale
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Memory Training
n=37 Participants
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.
|
Kundalini Yoga and Meditation
n=26 Participants
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.
|
|---|---|---|
|
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
|
2.70 units on a scale
Standard Deviation 20.48
|
|
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
|
3.12 units on a scale
Standard Deviation 39.91
|
|
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
|
2.77 units on a scale
Standard Deviation 46.01
|
|
Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)
Energy
|
-2.42 units on a scale
Standard Deviation 18.96
|
0.83 units on a scale
Standard Deviation 18.80
|
|
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
|
-3.33 units on a scale
Standard Deviation 19.00
|
|
Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)
Social Functioning
|
0 units on a scale
Standard Deviation 24.60
|
-9.89 units on a scale
Standard Deviation 36.29
|
|
Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)
Pain
|
-4.92 units on a scale
Standard Deviation 17.35
|
-7.50 units on a scale
Standard Deviation 25.31
|
|
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
|
-1.45 units on a scale
Standard Deviation 16.18
|
Adverse Events
Memory Training
Kundalini Yoga and Meditation
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Memory Training
n=39 participants at risk
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.
|
Kundalini Yoga and Meditation
n=40 participants at risk
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.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Food Poisoning
|
0.00%
0/39 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
|
Vascular disorders
Hypertension
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
0.00%
0/40 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
|
Immune system disorders
Vaccine side effect
|
0.00%
0/39 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
|
Immune system disorders
Flu
|
0.00%
0/39 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
2.5%
1/40 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
|
Immune system disorders
COVID-19
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
0.00%
0/40 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
|
Nervous system disorders
Steroid Injection
|
2.6%
1/39 • Number of events 1 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
0.00%
0/40 • Adverse event data were collected from baseline through study completion, up to six months.
Adverse events were assessed by asking participants whether they experienced any negative side effects
|
Additional Information
Helen Lavretsky, MD
University of California, Los Angeles
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place