Mild Cognitive Impairment
Conditions
Brief summary
Emerging studies in humans found that 40 Hz sound induces neural gamma oscillation and enhanced cognitive function in older adults with and without Alzheimer's Disease. We will compare a 40 Hz music intervention to both 40 Hz sound and music alone in a clinical cohort of older adults with mild cognitive impairment.
Interventions
BEHAVIORALA: 40 Hz music
The participant will listen to the 40 Hz music playlist one hour each day, 5 days a week for 4 weeks
BEHAVIORALB: 40 Hz sound
The participant will listen to the 40 Hz sound playlist one hour each day, 5 days a week for 4 weeks
BEHAVIORALC: Preferred music
The participant will listen to the preferred music playlist one hour each day, 5 days a week for 4 weeks
Sponsors
National Institute on Aging (NIA)
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
50 Years to 95 Years
Healthy volunteers
Yes
Inclusion criteria
1. Community-dwelling 2. amnesia mild cognitive impairment 3. Preserved function 4. No dementia
Exclusion criteria
1. known diagnosis of schizophrenia or Parkinson's disease; 2. severe hearing impairment; 3. presence of an acute medical or psychiatric condition which would interfere with the subject's ability to follow the study protocol realistically
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Baseline and 4 weeks | 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. |
| Global Cognition Assessed by the Cogstate Alzheimer's Battery | Baseline and Immediate after 4-week intervention | 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. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited from multiple sources including community recruitment, memory clinics, and online recruitment platforms.
Pre-assignment details
A total of 52 participants were consented. Fifteen participants who withdrew while waiting for randomization or 1st treatment were excluded. 37 participants were randomized.
Participants by arm
| Arm | Count |
|---|---|
| Sequence ABC 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 | 14 |
| Sequence BCA 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 | 10 |
| Sequence CAB 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 | 13 |
| Total | 37 |
Baseline characteristics
| Characteristic | Sequence ABC | Sequence BCA | Sequence CAB | Total |
|---|---|---|---|---|
| Age, Continuous | 68.2 years STANDARD_DEVIATION 7.8 | 68.7 years STANDARD_DEVIATION 6.3 | 66.7 years STANDARD_DEVIATION 7.1 | 67.8 years STANDARD_DEVIATION 7.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 6 Participants | 8 Participants | 23 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 4 Participants | 3 Participants | 5 Participants | 12 Participants |
| Sex: Female, Male Female | 8 Participants | 9 Participants | 6 Participants | 23 Participants |
| Sex: Female, Male Male | 6 Participants | 1 Participants | 7 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 34 | 0 / 30 | 0 / 32 |
| other Total, other adverse events | 0 / 34 | 0 / 30 | 0 / 32 |
| serious Total, serious adverse events | 0 / 34 | 0 / 30 | 0 / 32 |
Outcome results
Primary
Episodic Memory Assessed by the Cogstate Alzheimer's Battery
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.
Time frame: Baseline and 4 weeks
Population: Participants with data collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 Hz Music | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Baseline | -0.0746 z score | Standard Deviation 2.5595 |
| 40 Hz Music | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 0.5137 z score | Standard Deviation 2.57731 |
| 40 Hz Sound | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Baseline | 0.0700 z score | Standard Deviation 2.37813 |
| 40 Hz Sound | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 0.553 z score | Standard Deviation 2.5015 |
| Preferred Music | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Baseline | 0.0593 z score | Standard Deviation 2.1298 |
| Preferred Music | Episodic Memory Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 0.1614 z score | Standard Deviation 2.34475 |
Primary
Global Cognition Assessed by the Cogstate Alzheimer's Battery
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.
Time frame: Baseline and Immediate after 4-week intervention
Population: Participants with data collected
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 40 Hz Music | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Baseline | 8.3831 z score | Standard Deviation 35.542 |
| 40 Hz Music | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 18.6907 z score | Standard Deviation 28.38671 |
| 40 Hz Sound | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Baseline | 5.5993 z score | Standard Deviation 28.40206 |
| 40 Hz Sound | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 16.2249 z score | Standard Deviation 28.2289 |
| Preferred Music | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Baseline | 15.3345 z score | Standard Deviation 27.42554 |
| Preferred Music | Global Cognition Assessed by the Cogstate Alzheimer's Battery | Post-intervention | 10.4428 z score | Standard Deviation 29.44993 |