Daily Light and Sound Stimulation to Improve Brain Functions in Alzheimer's Disease

Not Applicable

Active, not recruiting

• Conditions: Alzheimer Disease; Alzheimer Dementia

• Registration Number: NCT04055376
• Lead Sponsor: Massachusetts Institute of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-8-5
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

Inclusion Criteria:<br><br> - Subject is between the ages of 50 - 100.<br><br> - Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE)<br> score of 19 -26.<br><br> - Subject is willing to sign informed consent document.<br><br> - If subject is deemed to not have capacity to sign the informed consent, he/she will<br> need a legally authorized representative to provide surrogate consent.<br><br> - Subjects whose primary residence is within 2 hours of Boston<br><br> - Able to complete the 1st month of at home stimulation at their primary residence; if<br> subjects plan to spend more than 1 week away from their primary residence during the<br> trial, their inclusion must be assessed by the research team.<br><br>Exclusion Criteria:<br><br> - Subjects who do not have healthcare.<br><br> - Subjects who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists<br> (eg. Memantine).<br><br> - Subjects on medications that lower seizure threshold such as wellbutrin,<br> ciprofloxacin, levofloxacin, etc.<br><br> - Subjects with history of seizure or epilepsy within the past 24 months.<br><br> - Subjects with clinically significant suicide risk and/or suicide attempt in the past<br> 12 months.<br><br> - Subjects with behavioral problems such as aggression/agitation/impulsivity that<br> might interfere with their ability to comply with protocol.<br><br> - Active treatment with one or more anti-epileptic agent.<br><br> - Subjects who have had a stroke within the past 24 months.<br><br> - Subjects diagnosed with migraine headache.<br><br> - Active treatment with one or more psychiatric agent (e.g. antidepressants,<br> antipsychotics, etc).<br><br> - Subjects who have an active implantable medical device including but not limited to<br> implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac<br> pacemaker, and/or sacral nerve stimulator.<br><br> - Subjects who have profound hearing or visual impairment.<br><br> - Subjects who have a life expectancy of less than 24 months.<br><br> - Subjects who are pregnant.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Feasibility of at-home light and sound stimulation: amount of time of device usage per day;Safety of daily at-home light and sound stimulation: questionnaire