Status:
RECRUITING
Gamma-Music Based Intervention for Mild Alzheimer's Disease
Lead Sponsor:
Northeastern University
Conditions:
Alzheimer Disease
Eligibility:
All Genders
50-95 years
Phase:
NA
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 ...
Detailed Description
Alzheimer's Disease (AD) is characterized by cognitive deficits such as memory loss, as well as deficits in the motivation that drives daily activities. These cognitive and motivational deficits are l...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
July 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT05984524
Start Date
July 1 2022
End Date
June 30 2027
Last Update
October 6 2023
Active Locations (1)
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1
Northeastern University
Boston, Massachusetts, United States, 02115