Music for Alzheimer's Disease Prevention

(iSTEP+ Trial)

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Kyoung Shin Park, PhD

Age: 65+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Emory University

Must not be taking: Alzheimer's medications, Anxiety, Depression

Disqualifiers: Neurological disorder, Cancer treatment, Stroke, others

No Placebo Group

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to test the benefits of beat-accented music stimulation (BMS) for behavioral changes of physical activity (PA) in older adults with subjective memory complaints. Specific Aims are to determine (1) whether BMS beneficially influences PA behaviors and psychological responses to PA in older adults for 6 months, and (2) whether exercising with BMS differently influences physical and cognitive functioning as well as quality of life in older adults.To test the effects of BMS on PA, participants will be randomly assigned to an exercise intervention that either includes BMS or does not include BMS. Participants will attend a supervised group strength training (ST) (30 min/day) and and aerobic exercise (AE) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both AE and ST on other days), and independently for the final 2 months (always with a goal of performing \>150min/week AE and 3 days/week of ST for 30 min/day).

Do I need to stop taking my current medications to join the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot participate if you are using medication for Alzheimer's disease or if you've changed the dosage of medications for anxiety or depression in the last 6 months.

What data supports the idea that Music for Alzheimer's Disease Prevention is an effective treatment?

The available research shows mixed results for the effectiveness of Music for Alzheimer's Disease Prevention. One study found that listening to Mozart improved spatial-temporal reasoning in a person with Alzheimer's, suggesting music might help with certain cognitive tasks. Another study noted that music-based interventions could improve quality of life and mood, though they had limited effects on cognition. Additionally, rhythmic auditory stimulation seemed to reduce the burden on caregivers during walking exercises, even if it didn't significantly change walking characteristics. Overall, while music shows some promise, more research is needed to fully understand its benefits compared to other treatments. ^{1 2 3 4 5}

What safety data exists for music-based treatments for Alzheimer's prevention?

The pilot study on Rhythmic Auditory Stimulation (RAS) with traumatic brain injury patients reported no adverse events, suggesting a favorable safety profile. However, specific safety data for music-based treatments in Alzheimer's prevention is not directly available in the provided research. Further studies are needed to confirm safety in this specific context. ^{6 7 8 9 10}

Is Beat-accented music stimulation (BMS) a promising treatment for Alzheimer's disease prevention?

Yes, Beat-accented music stimulation (BMS) is a promising treatment for Alzheimer's disease prevention. Research suggests that music can improve memory, mood, and cognitive functions in people with Alzheimer's. Music therapy can enhance quality of life, reduce medication needs, and help with mood and self-expression. It also shows potential in maintaining cognitive abilities and improving mood in dementia patients. ^{3 4 5 9 11}

Research Team

Kyoung Shin Park, PhD

Principal Investigator

Emory University

Eligibility Criteria

This trial is for older adults with memory complaints who are able to participate in regular physical activity. They should be willing to exercise with or without beat-accented music as part of the study and commit to a structured exercise program for 6 months.

Inclusion Criteria

Physically low-active by doing < 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months

Having self-perceived memory complaints

I am 65 years old or older.

Exclusion Criteria

I have not had a stroke or brain injury in the last 6 months.

I have been diagnosed with a neurological or spinal cord disorder.

Known exercise contraindications

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a supervised group strength training and aerobic exercise program with or without beat-accented music stimulation for 6 months

6 months

3 visits/week for the first 2 months, 1 visit/week for the next 2 months, independent for the final 2 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Post-test assessments within 4 weeks after the intervention

Treatment Details

Interventions

• Beat-accented music stimulation (BMS) (Behavioural Intervention)

Trial Overview The trial is testing if exercising while listening to beat-accented music can improve physical activity, cognitive function, and quality of life in seniors. Participants will do strength training and aerobic exercises either with or without music.

Participant Groups

Group I: Exercise and music Experimental Treatment 1 Intervention

The strength training (ST) program incorporates single-leg exercises for balance training and training with resistance bands and body weight. During the ST, participants will be asked to synchronize their concentric and eccentric muscle contractions in time with the tempo of BMS playlists at a specific music tempo. For aerobic exercise (AE), participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week. Participants will be trained to walk in synchrony with the beats. Participants will receive individualized music playlists to match individual walking cadence and music preference.

Group II: Exercise Active Control 1 Intervention

The ST program incorporates single-leg exercises for balance training and training with resistance bands and body weight. For AE, participants will be instructed to walk at moderate intensity with duration increasing up to an ultimate goal of 150 min/week.

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Dr. R. Donald Harvey

Emory University

Chief Medical Officer

MD from Emory University School of Medicine

Dr. George Painter

Emory University

Chief Executive Officer since 2013

PhD in Synthetic Organic Chemistry from Emory University

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

Dr. Joanne Pike

Alzheimer's Association

Chief Executive Officer since 2023

DrPH in Public Health Leadership from the University of North Carolina at Chapel Hill

Dr. Maria C. Carrillo

Alzheimer's Association

Chief Medical Officer

PhD in Neuroscience

University of North Carolina, Greensboro

Collaborator

Trials

33

Recruited

16,700+

Findings from Research

In a study involving 28 late-stage dementia patients, rhythmic auditory stimulation (with or without music) did not show statistically significant improvements in gait characteristics like cadence, velocity, or stride length compared to no auditory stimulus.

However, observations suggested that using rhythmic auditory stimulation may reduce the assistive burden on caregivers, indicating potential benefits for both patients and caregivers that warrant further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of rhythmic auditory stimulation (RAS) on gait characteristics of cadence, velocity, and stride length in persons with late stage dementia. Clair, AA., O'Konski, M.[2022]

In a study involving 11 patients with Alzheimer's disease, response-related music stimulation led to higher levels of positive participation, such as singing and smiling, in 6 out of the 11 patients compared to general music stimulation.

The findings suggest that incorporating active music response activities could be beneficial in daily programs for patients with Alzheimer's, particularly for enhancing engagement and emotional responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of response-related music stimulation versus general music stimulation on positive participation of patients with Alzheimer's disease. Lancioni, GE., Bosco, A., De Caro, MF., et al.[2018]

In a study involving twins discordant for Alzheimer's disease, the twin with AD showed significant improvement in spatial-temporal task scores after listening to a Mozart piano sonata, indicating a potential cognitive benefit from music.

No improvement was observed in the AD twin's scores after control conditions of silence or listening to 1930s popular tunes, suggesting that specific types of music may enhance cognitive function in individuals with Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancement of spatial-temporal reasoning after a Mozart listening condition in Alzheimer's disease: a case study. Johnson, JK., Cotman, CW., Tasaki, CS., et al.[2019]

In a study involving 105 older adults, including those with mild cognitive impairment (MCI), Alzheimer's disease (AD), and healthy controls, it was found that individuals with MCI maintained better functional connectivity between auditory and reward systems compared to those with AD.

The preserved connectivity in MCI suggests that music-based interventions could be particularly beneficial for this group, as they may still engage the brain's reward pathways effectively, motivating further research into MBIs for early-stage neurodegeneration.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Resting-State Connectivity of Auditory and Reward Systems in Alzheimer's Disease and Mild Cognitive Impairment. Wang, D., Belden, A., Hanser, SB., et al.[2020]

In a year-long study involving three case studies, gamma stimulation using 40 Hz auditory sound significantly helped maintain cognitive function and improve mood in participants with Alzheimer's disease or mild cognitive impairment.

The therapy was administered through a vibroacoustic chair for 30 minutes, five times a week, suggesting a structured approach that may be beneficial, but further research is needed to fully integrate this intervention into dementia care strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. Clements-Cortes, A., Bartel, L.[2023]

This pilot study involving 10 participants with traumatic brain injury (TBI) explored the feasibility and potential benefits of rhythmic auditory stimulation (RAS) over a 2-week treatment period, showing improvements in gait parameters without any adverse events.

After the RAS intervention, 50% of participants improved their Functional Gait Assessment scores, indicating they were no longer at high risk of falling, highlighting the potential efficacy of RAS in enhancing mobility in TBI patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study. Thompson, S., Hays, K., Weintraub, A., et al.[2021]

Continuous verbal cueing during music activities significantly increased participation in exercise among clients with Alzheimer's disease, suggesting that easier tasks and ongoing guidance can enhance engagement.

Instrumental music during exercise led to greater participation compared to vocal music, indicating that the type of music can influence the effectiveness of physical activities for individuals with Alzheimer's.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. Cevasco, AM., Grant, RE.[2019]

A pilot study involving 15 mildly anxious participants showed that listening to binaural beat tapes for 4 weeks significantly reduced daily anxiety scores, suggesting a potential therapeutic benefit.

Participants showed a preference for one specific tape with pronounced binaural beats, indicating that the characteristics of the audio may influence its effectiveness in reducing anxiety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. Le Scouarnec, RP., Poirier, RM., Owens, JE., et al.[2007]

Music exposure may improve memory and emotional function in individuals with Alzheimer's disease, highlighting its potential as a non-pharmacological intervention.

The review discusses possible neural mechanisms, including the dopaminergic system, autonomic nervous system, and default network, that could explain how music enhances cognitive function in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Music and Memory in Alzheimer's Disease and The Potential Underlying Mechanisms. Peck, KJ., Girard, TA., Russo, FA., et al.[2022]

Auditory beat stimulation (ABS), particularly binaural beats, shows potential for influencing cognitive processes and mood states, suggesting it could be a useful tool in therapeutic settings.

The review highlights the importance of stimulation parameters in ABS, as variations can lead to contradictory findings in research outcomes, indicating that careful design of stimulation protocols is crucial for effective results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auditory beat stimulation and its effects on cognition and mood States. Chaieb, L., Wilpert, EC., Reber, TP., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

The effect of rhythmic auditory stimulation (RAS) on gait characteristics of cadence, velocity, and stride length in persons with late stage dementia. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effects of response-related music stimulation versus general music stimulation on positive participation of patients with Alzheimer's disease. [2018]

3. England pubmed.ncbi.nlm.nih.gov

Enhancement of spatial-temporal reasoning after a Mozart listening condition in Alzheimer's disease: a case study. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Resting-State Connectivity of Auditory and Reward Systems in Alzheimer's Disease and Mild Cognitive Impairment. [2020]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Long-Term Multi-Sensory Gamma Stimulation of Dementia Patients: A Case Series Report. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Rhythmic Auditory Stimulation and Gait Training in Traumatic Brain Injury: A Pilot Study. [2021]

7. England pubmed.ncbi.nlm.nih.gov

Comparison of different methods for eliciting exercise-to-music for clients with Alzheimer's disease. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Use of binaural beat tapes for treatment of anxiety: a pilot study of tape preference and outcomes. [2007]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Music and Memory in Alzheimer's Disease and The Potential Underlying Mechanisms. [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Auditory beat stimulation and its effects on cognition and mood States. [2022]

11. France pubmed.ncbi.nlm.nih.gov

Alzheimer's disease: rhythm, timing and music as therapy. [2022]