Mild Cognitive ImpairmentNCT03503669

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

A study testing Memory Training and Kundalini yoga and meditation in people with Mild Cognitive Impairment and Alzheimer's Disease, run by University of California, Los Angeles at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 50 to 90 years, women only
Conditions the study is for: Mild Cognitive Impairment, Alzheimer's Disease
What is being tested?: Memory Training and Kundalini yoga and meditation
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteUnited States
Study dates: 1 May 2018to 1 Feb 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 50 to 90 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Amnestic MCI, as defined by a Clinical Dementia Rating Scale score of .5.
High cardiovascular risk defined as at least one of the following:
7.5 percentile risk or higher using ASCVD risk calculator
Myocardial Infarction more than 6 months ago
Diabetes
Taking medication for blood pressure > 140/90 blood pressure

Show all 9Show fewer

Taking medication for lyperlipidemia LDL >160
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

Who cannot join

History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder
Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition
Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)
Insufficient English proficiency to participate in either MET or KK+KY
Diagnosis of dementia
Mini Mental Health Examination score of 23 or below

Show all 10Show fewer

Currently taking any psychoactive medication
Participation in a psychotherapy that involves cognitive training
Practice of Kundalini Yoga or Kirtan Kriya within the past year
Myocardial Infarction within the past 6 months

Trial locations and contacts

1 site in 1 country.

United States1 site

UCLA Semel Institute
Los Angeles, California, 90095

Other trials in United States

About this study

Read the detailed description

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.

Conditions: Mild Cognitive Impairment, Alzheimer's Disease
Being tested: Memory Training, Kundalini yoga and meditation
Keywords: Memory impairment, Meditation, Yoga, Memory Training, Mild Cognitive Impairment, MCI, Geriatric, fMRI, Alzheimer's disease, Cardiovascular risk
Medical subject headings: Cognitive Dysfunction, Alzheimer Disease, Memory Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Memory TrainingBehavioural
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 meditationBehavioural
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.

Study groups in NCT03503669
Study group	Role	What they receive
Memory Training	Active comparator	Group memory training will be administered for amnestic mild cognitive impairment (MCI) Receives: Behavioral: Memory Training
Kundalini yoga and meditation	Experimental	Participants will engage in weekly yoga classes and daily 12 minute meditation Receives: Behavioral: Kundalini yoga and meditation

What is being measured

The primary outcome is the main question the study is designed to answer.

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: 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: 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: Measured at Baseline and Week 24

Secondary outcomes (2)

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.
Measured: 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: Measured at Baseline and Week 24, change from baseline to week 24 is reported.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 20181 Feb 2021

First posted20 Apr 2018
Study start1 May 2018
Primary completion8 Jan 2021
Study completion1 Feb 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
More trials run by University of California, Los AngelesThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03503669
Sponsor's protocol ID: 17-001876
Status last verified: Feb 2024
First submitted: 11 Apr 2018
Last updated: 8 Feb 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 35275541
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.
PubMed 38355715
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.
PubMed 37482992

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Reducing Risk for Alzheimer's Disease in High-Risk Women Through Yogic Meditation Training
ClinicalTrials.gov ID: NCT03503669
Acronym / sponsor ID: 17-001876
Conditions: Mild Cognitive Impairment, Alzheimer's Disease
Keywords: Memory impairment, Meditation, Yoga, Memory Training, Mild Cognitive Impairment, MCI, Geriatric, fMRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: University of California, Los AngelesUniversity, hospital or other
Collaborators: Alzheimer's Research and Prevention Foundation
Study start: 1 May 2018 (actual)
Primary completion: 8 Jan 2021 (actual)
Study completion: 1 Feb 2021 (actual)
First posted: 20 Apr 2018 (actual)
Results: Posted 8 Feb 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Memory Training	Active comparator	Behavioral: Memory TrainingGroup memory training will be administered for amnestic mild cognitive impairment (MCI)
Kundalini yoga and meditation	Experimental	Behavioral: Kundalini yoga and meditationParticipants will engage in weekly yoga classes and daily 12 minute meditation

Who may qualify

Ages: 50 to 90 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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

Key exclusion criteria (10 listed)

History of psychosis, bipolar disorder, alcohol/ drug dependence, or neurological disorder
Recent (within three months) surgery, anticipated surgery within next year, or unstable medical condition
Any disability preventing participation in MET or KK+KY (e.g., severe visual or hearing impairment)
Insufficient English proficiency to participate in either MET or KK+KY
Diagnosis of dementia

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Memory TrainingParticipants will attend a weekly memory training class for 12 weeks as well as receive daily memory homework (12 minute duration) for the 12 weeks.	Behavioural	Memory Training
Kundalini yoga and meditationParticipants 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.	Behavioural	Kundalini yoga and meditation

Primary outcome

Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score
Time frame: 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.
Change in Delayed Recall Cognitive Domain Scores
Time frame: 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.
Change in Executive Function Cognitive Domain Scores
Time frame: 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.

2 secondary outcomes

Change in Memory Functioning Questionnaire (MFQ) Scale
Time frame: 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)
Time frame: Measured at Baseline and Week 24, change from baseline to week 24 is reported.

Results and safety

Results posted to the registry on 8 Feb 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Memory Training	39	37
Kundalini Yoga and Meditation	40	26

Primary outcome: Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score

Time frame: Measured at Baseline and Week 24. Mean (Standard Deviation). Unit: units on a scale

Measure	Memory Training n = 37	Kundalini Yoga and Meditation n = 26
Value	-0.94 (5.10)	-1.65 (6.90)

Memory Training vs Kundalini Yoga and Meditation: p >0.05, Mixed Models Analysis

Primary outcome: Change in Delayed Recall Cognitive Domain Scores

Time frame: Measured at Baseline and Week 24. Mean (Standard Deviation). Unit: z-score

Measure	Memory Training n = 37	Kundalini Yoga and Meditation n = 26
Value	0.02 (0.55)	-0.31 (0.37)

Memory Training vs Kundalini Yoga and Meditation: p = 0.008, Mixed Models Analysis

Primary outcome: Change in Executive Function Cognitive Domain Scores

Time frame: Measured at Baseline and Week 24. Mean (Standard Deviation). Unit: z-score

Measure	Memory Training n = 37	Kundalini Yoga and Meditation n = 26
Value	-0.03 (0.70)	-0.04 (0.42)

Memory Training vs Kundalini Yoga and Meditation: p >0.05, Mixed Models Analysis

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected from baseline through study completion, up to six months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Memory Training	0 of 39 (0%)	3 of 39 (7.7%)	0 of 39
Kundalini Yoga and Meditation	0 of 40 (0%)	3 of 40 (7.5%)	0 of 40

Limitations and caveats (from the sponsor): After March 18th, 2020, all assessments were completed remotely due to COVID-19 until restrictions were lifted for eligible participants to come in-person.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 35275541Krause-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.
Derived from this study: PubMed 38355715Grzenda 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.
Derived from this study: PubMed 37482992Kilpatrick 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Helen Lavretsky, MS, MD principal investigator

UCLA Semel Institute

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Hopkins Verbal Learning Test (HVLT) Total Recall Score (time frame: Measured at Baseline and Week 24). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03503669, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2024.