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NCT03503669

Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training

Completed NA Results posted Last updated 8 February 2024
What this trial tests

NA trial testing Memory Training in Mild Cognitive Impairment in 100 participants. Completed in 1 February 2021.

Timeline
1 May 2018
Primary endpoint
8 January 2021
1 February 2021

Quick facts

Lead sponsorUniversity of California, Los Angeles
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingnone
Primary purposesupportive care
Enrollment100
Start date1 May 2018
Primary completion8 January 2021
Estimated completion1 February 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

University of California, Los Angeles

Who can join

Adults 50 to 90, female only, with Mild Cognitive Impairment or Alzheimer's Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score Primary · 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.

GroupValue95% CI
Memory Training-0.94± 5.10
Kundalini Yoga and Meditation-1.65± 6.90
Change in Delayed Recall Cognitive Domain Scores Primary · 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.

GroupValue95% CI
Memory Training0.02± 0.55
Kundalini Yoga and Meditation-0.31± 0.37
Change in Executive Function Cognitive Domain Scores Primary · 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.

GroupValue95% CI
Memory Training-0.03± 0.70
Kundalini Yoga and Meditation-0.04± 0.42
Change in Memory Functioning Questionnaire (MFQ) Scale Secondary · 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.

MFQ Factor 1
GroupValue95% CI
Memory Training0.29± 0.75
Kundalini Yoga and Meditation0.54± 1.03
MFQ Factor 2
GroupValue95% CI
Memory Training-0.30± 1.34
Kundalini Yoga and Meditation0.64± 1.24
MFQ Factor 3
GroupValue95% CI
Memory Training0.51± 1.58
Kundalini Yoga and Meditation0.70± 1.04
Change in Medical Outcomes Study Short Form 36-Item Health Survey (SF-36) Secondary · 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.

Physical Functioning
GroupValue95% CI
Memory Training0.60± 26.47
Kundalini Yoga and Meditation2.70± 20.48
Role Physical
GroupValue95% CI
Memory Training-15.90± 40.41
Kundalini Yoga and Meditation3.12± 39.91
Role Emotional
GroupValue95% CI
Memory Training-18.18± 44.16
Kundalini Yoga and Meditation2.77± 46.01
Energy
GroupValue95% CI
Memory Training-2.42± 18.96
Kundalini Yoga and Meditation0.83± 18.80
Emotional Wellbeing
GroupValue95% CI
Memory Training0.72± 14.01
Kundalini Yoga and Meditation-3.33± 19.00
Social Functioning
GroupValue95% CI
Memory Training0± 24.60
Kundalini Yoga and Meditation-9.89± 36.29
Pain
GroupValue95% CI
Memory Training-4.92± 17.35
Kundalini Yoga and Meditation-7.50± 25.31
General Health
GroupValue95% CI
Memory Training1.06± 13.33
Kundalini Yoga and Meditation-1.45± 16.18

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data were collected from baseline through study completion, up to six months.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Memory Training
Serious: 0/39 (0%)
Deaths: 0/39
Kundalini Yoga and Meditation
Serious: 0/40 (0%)
Deaths: 0/40
Other adverse events (6 terms — click to expand)

ReactionSystemMemory TrainingKundalini Yoga and Meditat…
Food PoisoningInjury, poisoning and procedural complications
HypertensionVascular disorders
Vaccine side effectImmune system disorders
FluImmune system disorders
COVID-19Immune system disorders
Steroid InjectionNervous system disorders

Data from ClinicalTrials.gov NCT03503669 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Yoga Prevents Gray Matter Atrophy in Women at Risk for Alzheimer's Disease: A Randomized Controlled Trial.
    Krause-Sorio B, Siddarth P, Kilpatrick L, Milillo MM, et al · · 2022 · cited 34× · PMID 35275541 · DOI 10.3233/jad-215563
  2. Cognitive and immunological effects of yoga compared to memory training in older women at risk for alzheimer's disease.
    Grzenda A, Siddarth P, Milillo MM, Aguilar-Faustino Y, et al · · 2024 · cited 19× · PMID 38355715 · DOI 10.1038/s41398-024-02807-0
  3. Women who breastfeed exhibit cognitive benefits after age 50.
    Fox M, Siddarth P, Oughli HA, Nguyen SA, et al · · 2021 · cited 10× · PMID 34754453 · DOI 10.1093/emph/eoab027
  4. Impact of Yoga Versus Memory Enhancement Training on Hippocampal Connectivity in Older Women at Risk for Alzheimer's Disease.
    Kilpatrick LA, Siddarth P, Krause-Sorio B, Milillo MM, et al · · 2023 · cited 9× · PMID 37482992 · DOI 10.3233/jad-221159
  5. The Effect of Cumulative Lifetime Estrogen Exposure on Cognition in Depressed Versus Non-Depressed Older Women.
    Oughli HA, Nguyen SA, Siddarth P, Fox M, et al · · 2022 · cited 5× · PMID 35410535 · DOI 10.1177/08919887221090216
  6. Peripheral Alzheimer's Disease Biomarkers Are Related to Change in Subjective Memory in Older Women with Cardiovascular Risk Factors in a Trial of Yoga vs. Memory Training: Lien établi entre les biomarqueurs périphériques de la maladie d'Alzheimer et l'amélioration de la mémoire
    Ajam Oughli H, Siddarth P, Lum M, Tang L, et al · · 2026 · cited 1× · PMID 40448323 · DOI 10.1177/07067437251343291
  7. 2024 International Congress on Integrative Medicine & Health Abstracts
    · 2024
  8. ACNP 61<sup>st</sup> Annual Meeting: Poster Abstracts P1 - P270.
    · 2022 · PMID 36456693 · DOI 10.1038/s41386-022-01484-1

Verify or expand the search:

Other trials of Memory Training

Trials testing the same drug.

Other recruiting trials for Mild Cognitive Impairment

Currently open trials in the same condition.

Other University of California, Los Angeles trials

Trials by the same sponsor.

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