Trial Outcomes & Findings for Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment (NCT NCT01983930)

Results Overview

Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning. 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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

81 participants

Primary outcome timeframe

At baseline and at 6 months

Results posted on

2018-10-23

Participant Flow

Single site outpatient clinic in the U.S.

168 volunteers were assessed for eligibility, of which 51 declined to participate and 32 did not meet inclusion criteria. Eighty-five volunteers consented to participate, of which 81 passed screening and were enrolled; two of 81 enrolled participants withdrew post-randomization and did not receive the allocated intervention.

Participant milestones

Participant milestones
Measure	Memory Training Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation PArticipants will engage in weekly yoga classes and daily 20 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.
Overall Study STARTED	41	38
Overall Study COMPLETED	32	29
Overall Study NOT COMPLETED	9	9

Reasons for withdrawal

Reasons for withdrawal
Measure	Memory Training Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation PArticipants will engage in weekly yoga classes and daily 20 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.
Overall Study Withdrawal by Subject	9	8
Overall Study Adverse Event	0	1

Baseline Characteristics

Memory Training Versus Yogic Meditation Training in Older Adults With Mild Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memory Training n=41 Participants Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation n=38 Participants Participants will engage in weekly yoga classes and daily 20 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.	Total n=79 Participants Total of all reporting groups
Age, Continuous	68.1 years STANDARD_DEVIATION 8.7 • n=5 Participants	67.6 years STANDARD_DEVIATION 8.0 • n=7 Participants	67.9 years STANDARD_DEVIATION 8.4 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	25 Participants n=7 Participants	52 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	13 Participants n=7 Participants	27 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	30 Participants n=5 Participants	24 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Non-Caucasian	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	38 Participants n=7 Participants	79 Participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline and at 6 months

Primary outcome measures were administered by a cognitive battery of neuropsychological and included memory and executive functioning. 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.

Outcome measures

Outcome measures
Measure	Memory Training n=41 Participants Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation n=38 Participants Participants will engage in weekly yoga classes and daily 20 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.
Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score Baseline	26.02 units on a scale Standard Deviation 5.42	25.76 units on a scale Standard Deviation 6.20
Cognitive Measures - Hopkins Verbal Learning Test (HVLT) Total Recall Score 6 Months	27.96 units on a scale Standard Deviation 5.44	28.81 units on a scale Standard Deviation 6.52

SECONDARY outcome

Timeframe: Baseline, weeks 2, 4, 6, 8, 10, 12, 24

Population: Data were not collected.

The CGI measures severity of illness and global improvement. The CGI is rated on a 7-point scale, with the severity of illness scale using a range of responses from 1 (normal) through to 7 (amongst the most severely ill patients). CGI global improvement scores range from 1 (very much improved) through to 7 (very much worse).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Week 24

Secondary outcomes measures included mood assessments with the GDS, a self-assessment scale often used in geriatric depression trials. The GDS is a 30-item screening tool used to identify depression in older adults. In scoring the Geriatric Depression Scale, each item is scored 0 or 1. The total score on the scale ranges from 0 to 30 with higher scores indicating worse outcome.

Outcome measures

Outcome measures
Measure	Memory Training n=41 Participants Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation n=38 Participants Participants will engage in weekly yoga classes and daily 20 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.
Geriatric Depression Scale (GDS) Baseline	5.7 units on a scale Standard Deviation 5.6	7.5 units on a scale Standard Deviation 5.1
Geriatric Depression Scale (GDS) Week 24	3.2 units on a scale Standard Deviation 2.5	3.9 units on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 12 weeks

FMRI scans will be obtained at baseline and after 12 weeks follow up. Default mode network findings were analyzed and significant effects were identified for yoga and memory enhancement training groups.

Outcome measures

Outcome measures
Measure	Memory Training n=11 Participants Group memory training will be administered for amnestic 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.	Kundalini Yoga and Meditation n=14 Participants Participants will engage in weekly yoga classes and daily 20 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.
Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity pregenual anterior cingulate cortex (ACC) p-value	0.011 p-value	0.001 p-value
Change in Functional Magnetic Resonance Imaging (fMRI) Connectivity frontal medial cortex (FMC) p-value	0.035 p-value	0.001 p-value

Adverse Events

Memory Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Kundalini Yoga and Meditation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Helen Lavretsky, M.D.

UCLA

Phone: 310-794-4619

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place