Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
NCT03503669, Not applicable, Completed, University of California, Los Angeles; results first posted 2024-02-08
Trial 12
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training | ClinicalTrials.gov |
| NCT number | NCT03503669 | ClinicalTrials.gov |
| Status | Completed | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 100 participants, actual | ClinicalTrials.gov |
| Lead sponsor | University of California, Los Angeles | ClinicalTrials.gov |
| Conditions | Mild Cognitive Impairment, Alzheimer's Disease | ClinicalTrials.gov |
| Interventions | Memory Training, Kundalini yoga and meditation | ClinicalTrials.gov |
| First posted | 2018-04-20 | ClinicalTrials.gov |
| Last updated | 2024-02-08 | ClinicalTrials.gov |
| Results first posted | 2024-02-08 | ClinicalTrials.gov |
| Limitations and caveats | After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person. | ClinicalTrials.gov |
Registered outcomes 5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Primary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
| Secondary | 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. | ClinicalTrials.gov |
Outcomes 5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|---|---|---|---|---|---|
| PRIMARY | Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score | Measured at Baseline and Week 24 | units on a scale | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Delayed Recall Cognitive Domain Scores | Measured at Baseline and Week 24 | z-score | MEAN | ClinicalTrials.gov | |
| PRIMARY | Change in Executive Function Cognitive Domain Scores | Measured at Baseline and Week 24 | z-score | MEAN | ClinicalTrials.gov | |
| SECONDARY | Change in Memory Functioning Questionnaire (MFQ) Scale | Measured at Baseline and Week 24, change from baseline to week 24 is reported. | units on a scale | MEAN | ClinicalTrials.gov | |
| SECONDARY | 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. | units on a scale | MEAN | ClinicalTrials.gov |
Results by group 28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|---|---|---|---|---|---|
| Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score | Memory Training | -0.94 | Standard Deviation 5.10 | units on a scale | ClinicalTrials.gov | |
| Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score | Kundalini Yoga and Meditation | -1.65 | Standard Deviation 6.90 | units on a scale | ClinicalTrials.gov | |
| Change in Delayed Recall Cognitive Domain Scores | Memory Training | 0.02 | Standard Deviation 0.55 | z-score | ClinicalTrials.gov | |
| Change in Delayed Recall Cognitive Domain Scores | Kundalini Yoga and Meditation | -0.31 | Standard Deviation 0.37 | z-score | ClinicalTrials.gov | |
| Change in Executive Function Cognitive Domain Scores | Memory Training | -0.03 | Standard Deviation 0.70 | z-score | ClinicalTrials.gov | |
| Change in Executive Function Cognitive Domain Scores | Kundalini Yoga and Meditation | -0.04 | Standard Deviation 0.42 | z-score | ClinicalTrials.gov | |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Memory Training | MFQ Factor 1 | 0.29 | Standard Deviation 0.75 | units on a scale | ClinicalTrials.gov |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Kundalini Yoga and Meditation | MFQ Factor 1 | 0.54 | Standard Deviation 1.03 | units on a scale | ClinicalTrials.gov |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Memory Training | MFQ Factor 2 | -0.30 | Standard Deviation 1.34 | units on a scale | ClinicalTrials.gov |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Kundalini Yoga and Meditation | MFQ Factor 2 | 0.64 | Standard Deviation 1.24 | units on a scale | ClinicalTrials.gov |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Memory Training | MFQ Factor 3 | 0.51 | Standard Deviation 1.58 | units on a scale | ClinicalTrials.gov |
| Change in Memory Functioning Questionnaire (MFQ) Scale | Kundalini Yoga and Meditation | MFQ Factor 3 | 0.70 | Standard Deviation 1.04 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Memory Training | Physical Functioning | 0.60 | Standard Deviation 26.47 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Kundalini Yoga and Meditation | Physical Functioning | 2.70 | Standard Deviation 20.48 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Memory Training | Role Physical | -15.90 | Standard Deviation 40.41 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Kundalini Yoga and Meditation | Role Physical | 3.12 | Standard Deviation 39.91 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Memory Training | Role Emotional | -18.18 | Standard Deviation 44.16 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Kundalini Yoga and Meditation | Role Emotional | 2.77 | Standard Deviation 46.01 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Memory Training | Energy | -2.42 | Standard Deviation 18.96 | units on a scale | ClinicalTrials.gov |
| Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) | Kundalini Yoga and Meditation | Energy | 0.83 | Standard Deviation 18.80 | units on a scale | ClinicalTrials.gov |
Participant flow 6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|---|---|---|---|---|
| Overall Study | STARTED | Memory Training | 39 | ClinicalTrials.gov | |
| Overall Study | STARTED | Kundalini Yoga and Meditation | 40 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Memory Training | 37 | ClinicalTrials.gov | |
| Overall Study | COMPLETED | Kundalini Yoga and Meditation | 26 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Memory Training | 2 | ClinicalTrials.gov | |
| Overall Study | NOT COMPLETED | Kundalini Yoga and Meditation | 14 | ClinicalTrials.gov |
Adverse events 12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|---|---|---|---|---|---|---|
| other | Food Poisoning | Injury, poisoning and procedural complications | Memory Training | 0 | 39 | 0 | ClinicalTrials.gov |
| other | Food Poisoning | Injury, poisoning and procedural complications | Kundalini Yoga and Meditation | 1 | 40 | 1 | ClinicalTrials.gov |
| other | Hypertension | Vascular disorders | Memory Training | 1 | 39 | 1 | ClinicalTrials.gov |
| other | Hypertension | Vascular disorders | Kundalini Yoga and Meditation | 0 | 40 | 0 | ClinicalTrials.gov |
| other | Vaccine side effect | Immune system disorders | Memory Training | 0 | 39 | 0 | ClinicalTrials.gov |
| other | Vaccine side effect | Immune system disorders | Kundalini Yoga and Meditation | 1 | 40 | 1 | ClinicalTrials.gov |
| other | Flu | Immune system disorders | Memory Training | 0 | 39 | 0 | ClinicalTrials.gov |
| other | Flu | Immune system disorders | Kundalini Yoga and Meditation | 1 | 40 | 1 | ClinicalTrials.gov |
| other | COVID-19 | Immune system disorders | Memory Training | 1 | 39 | 1 | ClinicalTrials.gov |
| other | COVID-19 | Immune system disorders | Kundalini Yoga and Meditation | 0 | 40 | 0 | ClinicalTrials.gov |
| other | Steroid Injection | Nervous system disorders | Memory Training | 1 | 39 | 1 | ClinicalTrials.gov |
| other | Steroid Injection | Nervous system disorders | Kundalini Yoga and Meditation | 0 | 40 | 0 | ClinicalTrials.gov |
Adverse event totals 6
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|---|---|---|---|
| Total, all-cause mortality | Memory Training | 0 | 39 | ClinicalTrials.gov |
| Total, all-cause mortality | Kundalini Yoga and Meditation | 0 | 40 | ClinicalTrials.gov |
| Total, other adverse events | Memory Training | 3 | 39 | ClinicalTrials.gov |
| Total, other adverse events | Kundalini Yoga and Meditation | 3 | 40 | ClinicalTrials.gov |
| Total, serious adverse events | Memory Training | 0 | 39 | ClinicalTrials.gov |
| Total, serious adverse events | Kundalini Yoga and Meditation | 0 | 40 | ClinicalTrials.gov |
Papers 3
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Memory Training vs Kundalini Yoga and Meditation: deaths from any cause | Trial comparisons |
| Memory Training vs Kundalini Yoga and Meditation: serious adverse events | Trial comparisons |
Tests 6
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Complex Figure Copy and Recall | Primary outcome | ConductCognition |
| Short Story Recall | Primary outcome | ConductCognition |
| Stroop Color-Word Test | Primary outcome | ConductCognition |
| Trail Making Test A | Primary outcome | ConductCognition |
| Trail Making Test B | Primary outcome | ConductCognition |
| Verbal Learning | Primary outcome | ConductCognition |
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)