Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT03503669
Status:
COMPLETED
Last Update Posted:
2024-02-08
First Post:
2018-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D008569', 'term': 'Memory Disorders'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000091942', 'term': 'Cognitive Training'}, {'id': 'D019122', 'term': 'Meditation'}], 'ancestors': [{'id': 'D000066530', 'term': 'Neurological Rehabilitation'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}, {'id': 'D026441', 'term': 'Mind-Body Therapies'}, {'id': 'D000529', 'term': 'Complementary Therapies'}, {'id': 'D026443', 'term': 'Spiritual Therapies'}, {'id': 'D012064', 'term': 'Relaxation Therapy'}, {'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'HLavretsky@mednet.ucla.edu', 'phone': '(310) 794-4619', 'title': 'Helen Lavretsky, MD', 'organization': 'University of California, Los Angeles'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from baseline through study completion, up to six months.', 'description': 'Adverse events were assessed by asking participants whether they experienced any negative side effects', 'eventGroups': [{'id': 'EG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 3, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.', 'otherNumAtRisk': 40, 'deathsNumAtRisk': 40, 'otherNumAffected': 3, 'seriousNumAtRisk': 40, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Food Poisoning', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Vaccine side effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Flu', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Immune system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Steroid Injection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 40, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'OG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.94', 'spread': '5.10', 'groupId': 'OG000'}, {'value': '-1.65', 'spread': '6.90', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Delayed Recall Cognitive Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'OG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02', 'spread': '0.55', 'groupId': 'OG000'}, {'value': '-0.31', 'spread': '0.37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.008', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'description': '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.\n\nRaw 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.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Executive Function Cognitive Domain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'OG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.03', 'spread': '0.70', 'groupId': 'OG000'}, {'value': '-0.04', 'spread': '0.42', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24', 'description': 'Executive Function Cognitive Domain score was constructed from:\n\nTrail Making Test A and B, Stroop Interference \\[Golden version\\] and FAS.\n\nRaw 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.', 'unitOfMeasure': 'z-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Memory Functioning Questionnaire (MFQ) Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'OG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'classes': [{'title': 'MFQ Factor 1', 'categories': [{'measurements': [{'value': '0.29', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '0.54', 'spread': '1.03', 'groupId': 'OG001'}]}]}, {'title': 'MFQ Factor 2', 'categories': [{'measurements': [{'value': '-0.30', 'spread': '1.34', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '1.24', 'groupId': 'OG001'}]}]}, {'title': 'MFQ Factor 3', 'categories': [{'measurements': [{'value': '0.51', 'spread': '1.58', 'groupId': 'OG000'}, {'value': '0.70', 'spread': '1.04', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24, change from baseline to week 24 is reported.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '37', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'OG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'classes': [{'title': 'Physical Functioning', 'categories': [{'measurements': [{'value': '0.60', 'spread': '26.47', 'groupId': 'OG000'}, {'value': '2.70', 'spread': '20.48', 'groupId': 'OG001'}]}]}, {'title': 'Role Physical', 'categories': [{'measurements': [{'value': '-15.90', 'spread': '40.41', 'groupId': 'OG000'}, {'value': '3.12', 'spread': '39.91', 'groupId': 'OG001'}]}]}, {'title': 'Role Emotional', 'categories': [{'measurements': [{'value': '-18.18', 'spread': '44.16', 'groupId': 'OG000'}, {'value': '2.77', 'spread': '46.01', 'groupId': 'OG001'}]}]}, {'title': 'Energy', 'categories': [{'measurements': [{'value': '-2.42', 'spread': '18.96', 'groupId': 'OG000'}, {'value': '0.83', 'spread': '18.80', 'groupId': 'OG001'}]}]}, {'title': 'Emotional Wellbeing', 'categories': [{'measurements': [{'value': '0.72', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '-3.33', 'spread': '19.00', 'groupId': 'OG001'}]}]}, {'title': 'Social Functioning', 'categories': [{'measurements': [{'value': '0', 'spread': '24.60', 'groupId': 'OG000'}, {'value': '-9.89', 'spread': '36.29', 'groupId': 'OG001'}]}]}, {'title': 'Pain', 'categories': [{'measurements': [{'value': '-4.92', 'spread': '17.35', 'groupId': 'OG000'}, {'value': '-7.50', 'spread': '25.31', 'groupId': 'OG001'}]}]}, {'title': 'General Health', 'categories': [{'measurements': [{'value': '1.06', 'spread': '13.33', 'groupId': 'OG000'}, {'value': '-1.45', 'spread': '16.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Measured at Baseline and Week 24, change from baseline to week 24 is reported.', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'FG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '37'}, {'groupId': 'FG001', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '14'}]}]}], 'preAssignmentDetails': '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.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)\n\nMemory 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.'}, {'id': 'BG001', 'title': 'Kundalini Yoga and Meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation\n\nKundalini 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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '67.5', 'spread': '9.3', 'groupId': 'BG000'}, {'value': '65.5', 'spread': '9.1', 'groupId': 'BG001'}, {'value': '66.48', 'spread': '9.20', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '69', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '40', 'groupId': 'BG001'}, {'value': '79', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hopkins Verbal Learning Test (HVLT)', 'classes': [{'categories': [{'measurements': [{'value': '26.66', 'spread': '5.48', 'groupId': 'BG000'}, {'value': '28.02', 'spread': '5.29', 'groupId': 'BG001'}, {'value': '27.34', 'spread': '5.40', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-09', 'size': 1701373, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2022-04-06T16:19', 'hasProtocol': True}, {'date': '2020-03-10', 'size': 583789, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2022-04-06T16:25', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-02-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-06', 'studyFirstSubmitDate': '2018-04-11', 'resultsFirstSubmitDate': '2022-04-26', 'studyFirstSubmitQcDate': '2018-04-18', 'lastUpdatePostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-06', 'studyFirstPostDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score', 'timeFrame': 'Measured at Baseline and Week 24', 'description': '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.'}, {'measure': 'Change in Delayed Recall Cognitive Domain Scores', 'timeFrame': 'Measured at Baseline and Week 24', 'description': '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.\n\nRaw 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.'}, {'measure': 'Change in Executive Function Cognitive Domain Scores', 'timeFrame': 'Measured at Baseline and Week 24', 'description': 'Executive Function Cognitive Domain score was constructed from:\n\nTrail Making Test A and B, Stroop Interference \\[Golden version\\] and FAS.\n\nRaw 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.'}], 'secondaryOutcomes': [{'measure': 'Change in Memory Functioning Questionnaire (MFQ) Scale', 'timeFrame': 'Measured at Baseline and Week 24, change from baseline to week 24 is reported.', 'description': '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.'}, {'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.', 'description': '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.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Memory impairment', 'Meditation', 'Yoga', 'Memory Training', 'Mild Cognitive Impairment', 'MCI', 'Geriatric', 'fMRI', "Alzheimer's disease", 'Cardiovascular risk'], 'conditions': ['Mild Cognitive Impairment', "Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '35275541', 'type': 'RESULT', '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."}, {'pmid': '38355715', 'type': 'DERIVED', 'citation': "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."}, {'pmid': '37482992', 'type': 'DERIVED', 'citation': "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."}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '50 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5.\n2. High cardiovascular risk defined as at least one of the following:\n\n * 7.5 percentile risk or higher using ASCVD risk calculator\n * Myocardial Infarction more than 6 months ago\n * Diabetes\n * Taking medication for blood pressure \\> 140/90 blood pressure\n * Taking medication for lyperlipidemia LDL \\>160\n3. 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)\n4. Capacity to provide informed consent\n\nExclusion Criteria:\n\n1. History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder\n2. Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition\n3. Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)\n4. Insufficient English proficiency to participate in either MET or KK+KY\n5. Diagnosis of dementia\n6. Mini Mental Health Examination score of 23 or below\n7. Currently taking any psychoactive medication\n8. Participation in a psychotherapy that involves cognitive training\n9. Practice of Kundalini Yoga or Kirtan Kriya within the past year\n10. Myocardial Infarction within the past 6 months'}, 'identificationModule': {'nctId': 'NCT03503669', 'briefTitle': "Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training", 'organization': {'class': 'OTHER', 'fullName': 'University of California, Los Angeles'}, 'officialTitle': "Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training", 'orgStudyIdInfo': {'id': '17-001876'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Memory Training', 'description': 'Group memory training will be administered for amnestic mild cognitive impairment (MCI)', 'interventionNames': ['Behavioral: Memory Training']}, {'type': 'EXPERIMENTAL', 'label': 'Kundalini yoga and meditation', 'description': 'Participants will engage in weekly yoga classes and daily 12 minute meditation', 'interventionNames': ['Behavioral: Kundalini yoga and meditation']}], 'interventions': [{'name': 'Memory Training', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Memory Training']}, {'name': 'Kundalini yoga and meditation', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Kundalini yoga and meditation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Semel Institute', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}], 'overallOfficials': [{'name': 'Helen Lavretsky, MS, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UCLA Semel Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Los Angeles', 'class': 'OTHER'}, 'collaborators': [{'name': "Alzheimer's Research and Prevention Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Helen Lavretsky, MD', 'investigatorAffiliation': 'University of California, Los Angeles'}}}}