Music for Alzheimer's Disease Prevention

(iSTEP+ Trial)

Recruiting at 1 trial location

Overseen By Study Team

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: Emory University

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

Disqualifiers: Neurological disorder, Cancer treatment, Stroke, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether listening to beat-accented music during exercise can encourage older adults with memory concerns to be more active and improve their quality of life. Participants will perform strength and aerobic exercises, with some listening to music that matches their movements. The study seeks individuals aged 65 and older who have noticed memory problems, are not currently very active, and can walk without assistance. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance daily life for older adults.

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 prior data suggests that beat-accented music stimulation is safe for older adults with subjective memory complaints?

Research has shown that beat-accented music stimulation (BMS) is generally safe. An initial study with rhythmic sound stimulation, similar to BMS, found that participants with brain injuries did not report negative effects, suggesting BMS is likely safe.

Additionally, studies have found that listening to music during exercise can enhance positive feelings and make workouts feel easier. This indicates that BMS might not only be safe but also enjoyable for participants.

Overall, current evidence supports the safety of BMS, making it a promising option for those interested in trials focused on music and exercise. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using beat-accented music stimulation (BMS) for Alzheimer's prevention because it represents a fresh approach that combines music with physical exercise. Unlike traditional treatments for Alzheimer's, which often focus on medications to manage symptoms, this method aims to engage the brain through rhythm and movement. By syncing exercise with personalized music playlists, BMS may enhance cognitive function and improve physical health simultaneously. This innovative blend of music and exercise could potentially offer a non-pharmaceutical option for reducing the risk of Alzheimer's in a fun and engaging way.

What evidence suggests that beat-accented music stimulation is effective for Alzheimer's disease prevention?

Research shows that music with strong beats, known as beat-accented music stimulation (BMS), can increase activity levels during exercise. Studies have found that this type of music encourages more exercise compared to music without strong beats and helps individuals maintain their exercise routines. Additionally, training with music has been linked to improved learning, memory, and attention. In this trial, one group of participants will exercise with BMS, while another group will exercise without music. Although direct evidence of BMS specifically aiding Alzheimer's disease is limited, these findings suggest it could improve physical activity and brain function in older adults with memory issues. ^{1 6 7 8 9}

Who Is on the Research Team?

Kyoung Shin Park, PhD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

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.

Known exercise contraindications

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Beat-accented music stimulation (BMS)

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.

How Is the Trial Designed?

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+

Alzheimer's Association

Collaborator

Trials

103

Recruited

44,300+

University of North Carolina, Greensboro

Collaborator

Trials

33

Recruited

16,700+

Published Research Related to This Trial

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]

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]

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 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]

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]

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]

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]

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]

Active music-making can serve as an effective therapy for Alzheimer's patients, helping to maintain cognitive functions and improve quality of life through social interaction and self-expression.

Music therapy may reduce the need for tranquilizers and hypnotics, promoting mood improvement and enhancing mental processes, suggesting it could be a valuable part of rehabilitation strategies for Alzheimer's patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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

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]

Citations

1. withpower.com withpower.com/trial/phase-alzheimer-disease-4-2024-27676

Music for Alzheimer's Disease Prevention (iSTEP+ Trial) In a study involving 28 late-stage dementia patients, rhythmic auditory stimulation (with or without music) did not show statistically significant improvements ...

2. medrxiv.org medrxiv.org/content/10.1101/2023.04.30.23289323v1.full-text

Feasibility of multicomponent exercise training with beat- ... Beat-accented music stimulation can be combined with exercise training to manipulate exercise tempo, which may be associated with good adherence ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10475546/

Music-based multicomponent exercise training for community ... These findings suggest that the distinctive combination of music with accented beats can dramatically increase PA above and beyond beat-unaccented music.

4. researchgate.net researchgate.net/publication/370553899_Feasibility_of_multicomponent_exercise_training_with_beat-accentuated_music_among_community-dwelling_older_adults_with_mild-to-moderate_cognitive_decline

Feasibility of multicomponent exercise training with beat- ... As a form of rhythmic auditory stimulation, beat-accentuated music can be combined with exercise training to manipulate exercise tempo and may provide a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11057238/

Effects of movement training based on rhythmic auditory ... Ronnie Gardner's rhythm and music (RGRM) training have been shown to improve learning and episodic memory, speed, attention, visuospatial ...

6. reporter.nih.gov reporter.nih.gov/project-details/11384062

Project Details Interestingly, listening to music during acute bouts of AE and ST increases positive affect and reduces perceived exertion. However, for these benefits to ...

7. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2023.1224728/full

Music-based multicomponent exercise training for ... This study explored the feasibility and preliminary efficacy of a music-based, multicomponent exercise intervention among community-dwelling older adults

8. medrxiv.org medrxiv.org/content/10.1101/2023.04.30.23289323v1.full.pdf

Feasibility of multicomponent exercise training with beat- ... We further demonstrated increased positive affect and reduced RPE by exercising with Beat-accentuated Music Stimulation (BMS) in an acute phase ...

9. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/69/NCT05309369/Prot_SAP_001.pdf

Musical Engagement of brain LObes in Alzheimer's ... Data safety and ... well as lack of significant risk of listening to music intervention, no Data Safety Monitoring Board is required.