Trial Outcomes & Findings for Sound and Music for Mild Cognitive Impairment (NCT NCT05064007)

Last Updated: 2025-08-29

Results Overview

The composite episodic memory score is calculated as a Z-score, representing the sum of the Z-scores across three Cogstate computerized assessments: One Card Learning, International Shopping List, and Delayed Recall. For each test, a Z-score is calculated relative to the first baseline assessment of all included subjects, using the formula (score - mean at first baseline assessment) / standard deviation at first baseline assessment. The composite Z-score is then calculated by summing these individual Z-scores. A composite Z-score of 0 corresponds to performance exactly at the study-sample mean at the first baseline assessment. Positive, or higher, composite Z-scores reflect better episodic-memory performance-they show how many standard deviations above the baseline mean the summed score lies. Conversely, negative, or lower, composite Z-scores reflect poorer episodic-memory performance, indicating how many standard deviations below the baseline mean the score falls.

Recruitment status

COMPLETED

Study phase

Target enrollment

52 participants

Primary outcome timeframe

Baseline and 4 weeks

Results posted on

2025-08-29

Participant Flow

Participants were recruited from multiple sources including community recruitment, memory clinics, and online recruitment platforms.

A total of 52 participants were consented. Fifteen participants who withdrew while waiting for randomization or 1st treatment were excluded. 37 participants were randomized.

Participant milestones

Participant milestones
Measure	Sequence 1: This Group Will be Exposed to Condition A First, Then B, and C A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks	Sequence 2: This Group Will be Exposed to Condition B First, Then C, and A A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks	Sequence 3: This Group Will be Exposed to Condition C First, Then A, and B A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
First Intervention (4 Weeks) STARTED	14	10	13
First Intervention (4 Weeks) COMPLETED	14	10	12
First Intervention (4 Weeks) NOT COMPLETED	0	0	1
Washout (10-14 Days) STARTED	11	10	10
Washout (10-14 Days) COMPLETED	9	10	8
Washout (10-14 Days) NOT COMPLETED	2	0	2
Second Intervention (4 Weeks) STARTED	12	10	10
Second Intervention (4 Weeks) COMPLETED	11	10	10
Second Intervention (4 Weeks) NOT COMPLETED	1	0	0
Third Intervention (4 Weeks) STARTED	9	10	8
Third Intervention (4 Weeks) COMPLETED	8	9	8
Third Intervention (4 Weeks) NOT COMPLETED	1	1	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Sound and Music for Mild Cognitive Impairment

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Sequence ABC n=14 Participants this group will be exposed to condition A first, then B, and C A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks	Sequence BCA n=10 Participants this group will be exposed to condition B first, then C, and A A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks	Sequence CAB n=13 Participants This group will be exposed to condition C first, then A, and B A: 40 Hz music: The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks B: 40 Hz sound: The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks C: Preferred music: The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks	Total n=37 Participants Total of all reporting groups
Age, Continuous	68.2 years STANDARD_DEVIATION 7.8 • n=5 Participants	68.7 years STANDARD_DEVIATION 6.3 • n=7 Participants	66.7 years STANDARD_DEVIATION 7.1 • n=5 Participants	67.8 years STANDARD_DEVIATION 7.1 • n=4 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	6 Participants n=5 Participants	23 Participants n=4 Participants
Sex: Female, Male Male	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants	14 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants	23 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline and 4 weeks

Population: Participants with data collected

Outcome measures

Outcome measures
Measure	40 Hz Music n=33 Participants Participants who were assigned to listen to the 40 Hz music playlist one hour each day, 5 days a week, for 4 weeks	40 Hz Sound n=28 Participants The participants were assigned to listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks	Preferred Music n=30 Participants The participants who were assigned to listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Episodic Memory Assessed by the Cogstate Alzheimer's Battery Baseline	-0.0746 z score Standard Deviation 2.5595	0.0700 z score Standard Deviation 2.37813	0.0593 z score Standard Deviation 2.1298
Episodic Memory Assessed by the Cogstate Alzheimer's Battery Post-intervention	0.5137 z score Standard Deviation 2.57731	0.553 z score Standard Deviation 2.50150	0.1614 z score Standard Deviation 2.34475

PRIMARY outcome

Timeframe: Baseline and Immediate after 4-week intervention

Population: Participants with data collected

The composite global cognitive score is expressed as a Z-score obtained by summing the Z-scores from six Cogstate computerized assessments: Identification, Detection, One Card Learning, One Back, International Shopping List-Delayed Recall, and Groton Maze Learning. For each task, an individual Z-score is calculated with reference to the first baseline assessment of all enrolled participants using the formula (individual score - baseline mean) / baseline standard deviation. These task-specific Z-scores are then summed to yield the composite value. A composite Z-score of 0 denotes performance exactly at the study-sample mean at the first baseline assessment. Positive-or higher-composite Z-scores reflect better global cognitive performance because they indicate performance a given number of standard deviations above that first baseline mean, whereas negative-or lower-composite Z-scores reflect poorer performance by indicating the number of standard deviations below the mean.

Outcome measures

Outcome measures
Measure	40 Hz Music n=30 Participants Participants who were assigned to listen to the 40 Hz music playlist one hour each day, 5 days a week, for 4 weeks	40 Hz Sound n=29 Participants The participants were assigned to listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks	Preferred Music n=25 Participants The participants who were assigned to listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Global Cognition Assessed by the Cogstate Alzheimer's Battery Baseline	8.3831 z score Standard Deviation 35.542	5.5993 z score Standard Deviation 28.40206	15.3345 z score Standard Deviation 27.42554
Global Cognition Assessed by the Cogstate Alzheimer's Battery Post-intervention	18.6907 z score Standard Deviation 28.38671	16.2249 z score Standard Deviation 28.2289	10.4428 z score Standard Deviation 29.44993

Adverse Events

40 Hz Music

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

40 Hz Sound

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Preferred Music

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

Dr. Junxin Li

Johns Hopkins University

Phone: 4105022608

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place