Gamma-frequency music therapy for mild Alzheimer's disease
Gamma-Music Based Intervention for Mild Alzheimer's Disease
This study is testing a new therapy that uses special music and light to see if it can help people with mild Alzheimer's disease feel better and slow down their symptoms.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 50 Years to 95 Years |
| Sex | All |
| Sponsor | Northeastern University Academic / other |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05984524 on ClinicalTrials.gov |
What this trial studies
This study tests a novel brain-stimulation tool that combines gamma-frequency light with self-selected music to create a gamma-music-based intervention for individuals with mild Alzheimer's Disease. The approach aims to influence brain activity, enhance motivation, and identify which patients may benefit most from this intervention. By integrating neurostimulation with music therapy, the project seeks to develop a sustainable method to delay the progression of Alzheimer's Disease and improve cognitive function. The study will evaluate the effectiveness of this combined therapy in promoting healthy neurocognitive aging.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 55-90 with mild Alzheimer's Disease who meet specific cognitive and functional criteria.
Not a fit: Patients with significant cerebrovascular disease, major psychiatric disorders, or those with a history of substance abuse may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could help delay the progression of Alzheimer's Disease and improve cognitive function in affected patients.
How similar studies have performed: While the approach of combining gamma-frequency neurostimulation with music therapy is innovative, preliminary studies in animal models have shown promise, but human applications are still largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Mild AD participants will be ages 55-90, amnestic (single or multiple domain) who perform below an education- adjusted cut-off score on the Logical Memory II subscale delayed paragraph recall of the Wechsler Memory Scale-Revised (WMS-R LM-IIa) (Wechsler 1987) (≥16 years: ≤8; 8-15 years: ≤4; 0-7 years: ≤2), have a CDR global score of 0.5 (with a memory box score of 0.5 or 1), have an MMSE score of 20-24, and have preserved instrumental activities of daily living (ADL) as determined by the Alzheimer's Disease Cooperative Study ADL Prevention Instrument (ADCS ADL-PI). All participants will be medically stable. Participants will not have significant cerebrovascular disease determined by history of stroke, and will have a Modified Hachinski Ischemic score (Rosen et al. 1980) of ≤ 4. Participants will not have significant psychiatric disorders including a Geriatric Depression Scale (long form) (Yesavage et al. 1982) of ≤10, and will not have a history of substance or alcohol abuse. All participants must be on stable doses of any medications with psychotropic effects (including cholinesterase inhibitors, memantine, and antidepressants) for at least 3 months prior to randomization. Participants will be screened to be amyloid positive via plasma test. They must also have no contraindications to MRI scanning, and will have a study partner who is able to provide collateral information about the participant. A pure tone audiogram will be administered to ensure that participants have no more than mild levels of hearing loss (\<40dB). If a subject fails audiometric screening, they will be excluded from the study and provided with a list of audiologists. An Institutional Review Board (IRB) approved telephone screen will be used for demographic information, study inclusion/exclusion criteria and MRI contraindications. Participants will complete an MRI screening questionnaire before each MRI session.
Where this trial is running
Boston, Massachusetts
- Northeastern University — Boston, Massachusetts, United States (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.