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Behavioural Intervention

Light and Sound Stimulation for Alzheimer's Disease

N/A

Waitlist Available

Led By Emery Brown, MD, PhD

Research Sponsored by Massachusetts Institute of Technology

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19 -26

Subject is between the ages of 50 - 100

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, month 1, month 3, month 6, and either month 7 or month 12 and month 13. covid-19 amendment:baseline, month 1, month 3, month 9, and either month 10 or month 18 and month 19.

Awards & highlights

Study Summary

This trial is studying the safety and effect of daily exposure to light and sound stimulation on people with mild Alzheimer's Disease. Due to the ongoing suspension of in-person research because of COVID-19, all enrolled participants who have not completed their 6-month visit will have their visit postponed to 9 months with a follow up at 18 months.

Who is the study for?

This trial is for people aged 50-100 with mild Alzheimer's Disease, scoring 19-26 on the MMSE. They must live within two hours of Boston and be able to do a month of home stimulation. Excluded are those at suicide risk, recent stroke survivors, life expectancy under 24 months, without healthcare, taking certain medications like NMDA antagonists or seizure threshold lowering drugs, with active implants (e.g., pacemakers), pregnant women, those on anti-epileptic or psychiatric meds, and individuals with severe hearing/vision loss or behavioral issues.Check my eligibility

What is being tested?

The GENUS device is being tested for its safety and effectiveness in improving brain functions in mild Alzheimer's patients through daily light and sound stimulation. Participants will use either the active settings of the device or sham (inactive) settings as a comparison over an extended period due to COVID-19 adjustments.See study design

What are the potential side effects?

While not explicitly listed in the provided information, potential side effects may include discomfort from light/sound exposure such as headaches or sensory overload. Since it's non-invasive stimulation therapy using light and sound only; no significant side effects are expected.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My Alzheimer's is mild, with an MMSE score between 19 and 26.

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I am between 50 and 100 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, month 1, month 3, month 6, and either month 7 or month 12 and month 13. covid-19 amendment:baseline, month 1, month 3, month 9, and either month 10 or month 18 and month 19.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, month 1, month 3, month 6, and either month 7 or month 12 and month 13. covid-19 amendment:baseline, month 1, month 3, month 9, and either month 10 or month 18 and month 19.

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, month 1, month 3, month 6, and either month 7 or month 12 and month 13. covid-19 amendment:baseline, month 1, month 3, month 9, and either month 10 or month 18 and month 19. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Other outcome measures

Change in Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) score

Change in Clinical Dementia Rating Scale - Sum of Boxes (CDR-SB)

Change in Functional Assessment Scale (FAS)

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Daily exposure to active stimulationExperimental Treatment1 Intervention

Subjects in this arm will receive daily exposure to active stimulation

Group II: Daily exposure to control stimulationPlacebo Group1 Intervention

Subjects in this arm will receive daily exposure to control stimulation

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts Institute of TechnologyLead Sponsor

97 Previous Clinical Trials

12,729,972 Total Patients Enrolled

Emery Brown, MD, PhDPrincipal InvestigatorMassachusetts Institute of Technology

Li-Huei Tsai, PhDPrincipal InvestigatorMassachusetts Institute of Technology

3 Previous Clinical Trials

180 Total Patients Enrolled

Media Library

GENUS device (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04055376 — N/A

Alzheimer's Disease Research Study Groups: Daily exposure to control stimulation, Daily exposure to active stimulation

Alzheimer's Disease Clinical Trial 2023: GENUS device Highlights & Side Effects. Trial Name: NCT04055376 — N/A

GENUS device (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04055376 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who is the most suitable demographic for involvement in this experiment?

"This clinical trial seeks 15 elderly patients with Alzheimer's disease between the ages of 50 and 100. To be eligible, applicants must have a Mini Mental State Exam score ranging from 19 to 26, as well as demonstrate their ability to complete one month of home stimulation at their primary residence (if they plan on leaving for longer than seven days during the study, approval from the research team is required). Furthermore, candidates should live within two hours' drive of Boston."

Answered by AI

Are there opportunities for patients to participate in this trial?

"As evidenced on clinicaltrials.gov, this research that began in August 2019 is now closed to new participants. Though its recruitment window has ended, there are an abundance of other studies enrolling patients at present."

Answered by AI