NCT05984524 Gamma-Music Based Intervention for Mild Alzheimer's Disease
| NCT ID | NCT05984524 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Northeastern University |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-07-01 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-07-01 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The study will test and refine a novel brain-stimulation tool using gamma-frequency lights coupled with self-selected music for a gamma-music-based intervention for participants with mild Alzheimer's Disease. Results will yield a gamma-stimulation protocol that reliably influences brain activity (Aim 1), is adaptive, motivating and rewarding to use (Aim 2), and will generate predictions as to who might benefit the most from gamma-MBI (Aim 3). By bridging the gap between neurostimulation and behavioral intervention by combining music therapy with gamma- band neurostimulation, the present project aims to find a sustainable intervention that delays the progression of AD.
Eligibility 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.
Frequently Asked Questions
Who can join the NCT05984524 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 95 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05984524 currently recruiting?
Yes, NCT05984524 is actively recruiting participants. Visit ClinicalTrials.gov or contact Northeastern University to inquire about joining.
Where is the NCT05984524 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT05984524 clinical trial?
NCT05984524 is sponsored by Northeastern University. The trial plans to enroll 60 participants.
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