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| Name | Class |
|---|---|
| Alzheimer's Research and Prevention Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Memory Training | Active Comparator | Group memory training will be administered for amnestic mild cognitive impairment (MCI) |
|
| Kundalini yoga and meditation | Experimental | Participants will engage in weekly yoga classes and daily 12 minute meditation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Measured at Baseline and Week 24 |
| 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. | Measured at Baseline and Week 24 |
| 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. | Measured at Baseline and Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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:
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| Name | Affiliation | Role |
|---|---|---|
| Helen Lavretsky, MS, MD | UCLA Semel Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCLA Semel Institute | Los Angeles | California | 90095 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35275541 | Result | 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. | |
| 38355715 | Derived | Grzenda A, Siddarth P, Milillo MM, Aguilar-Faustino Y, Khalsa DS, Lavretsky H. Cognitive and immunological effects of yoga compared to memory training in older women at risk for alzheimer's disease. Transl Psychiatry. 2024 Feb 14;14(1):96. doi: 10.1038/s41398-024-02807-0. |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Kundalini Yoga and Meditation |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at Baseline and Week 24 |
|
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Food Poisoning | Injury, poisoning and procedural complications | Non-systematic Assessment |
After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Helen Lavretsky, MD | University of California, Los Angeles | (310) 794-4619 | HLavretsky@mednet.ucla.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 9, 2020 | Apr 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2020 | Apr 6, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| D000544 | Alzheimer Disease |
| D008569 | Memory Disorders |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D003704 | Dementia |
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| ID | Term |
|---|---|
| D000091942 | Cognitive Training |
| D019122 | Meditation |
| ID | Term |
|---|---|
| D000066530 | Neurological Rehabilitation |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
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| 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. |
|
| Measured at Baseline and Week 24, change from baseline to week 24 is reported. |
| 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. | Measured at Baseline and Week 24, change from baseline to week 24 is reported. |
| 37482992 | Derived | Kilpatrick LA, Siddarth P, Krause-Sorio B, Milillo MM, Aguilar-Faustino Y, Ercoli L, Narr KL, Khalsa DS, Lavretsky H. Impact of Yoga Versus Memory Enhancement Training on Hippocampal Connectivity in Older Women at Risk for Alzheimer's Disease. J Alzheimers Dis. 2023;95(1):149-159. doi: 10.3233/JAD-221159. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Hopkins Verbal Learning Test (HVLT) | Hopkins Verbal Learning Test (HVLT) is a verbal memory task with 12 words learned over three trials, with the correct words summed for the Total Recall score (range = 0 - 36), with higher scores representing better performance. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. |
|
|
|
| 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. | Posted | Mean | Standard Deviation | z-score | Measured at Baseline and Week 24 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | z-score | Measured at Baseline and Week 24 |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at Baseline and Week 24, change from baseline to week 24 is reported. |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Measured at Baseline and Week 24, change from baseline to week 24 is reported. |
|
|
|
|
| 0 |
| 39 |
| 0 |
| 39 |
| 3 |
| 39 |
| EG001 | 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. | 0 | 40 | 0 | 40 | 3 | 40 |
| Hypertension | Vascular disorders | Non-systematic Assessment |
|
| Vaccine side effect | Immune system disorders | Non-systematic Assessment |
|
| Flu | Immune system disorders | Non-systematic Assessment |
|
| COVID-19 | Immune system disorders | Non-systematic Assessment |
|
| Steroid Injection | Nervous system disorders | Non-systematic Assessment |
|
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| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005791 |
| Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D026443 | Spiritual Therapies |
| D012064 | Relaxation Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| MFQ Factor 3 |
|
| Role Emotional |
|
| Energy |
|
| Emotional Wellbeing |
|
| Social Functioning |
|
| Pain |
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| General Health |
|