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

Must not have

Active treatment with one or more anti-epileptic agent

Subjects with history of seizure or epilepsy within the past 24 months

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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently taking medication for epilepsy.

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I have not had a seizure or been diagnosed with epilepsy in the last 2 years.

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I have had a stroke in the last 2 years.

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I am currently taking medication for a mental health condition.

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I have been diagnosed with migraine headaches.

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I am currently taking medication that affects NMDA receptors.

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I have severe hearing or vision loss.

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.