Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Al… (NCT05776641) | Clinical Trial Compass
RecruitingNot Applicable
Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease
United States200 participantsStarted 2024-06-21
Plain-language summary
Alzheimer's disease (AD) is characterized by significant memory loss, toxic protein deposits (amyloid and tau) in the brain, and changes in the gamma frequency band on EEG. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain. The Tsai lab found that boosting gamma waves in AD mouse models using light and sound stimulation at 40Hz not only reduced amyloid and tau in the brain, but also improved memory. A light and sound device was developed for humans that stimulates the brain at 40Hz that can be used safely at home. The goal of this study is to see if using this device can prevent dementia in people who are at risk for developing Alzheimer's disease.
Who can participate
Age range
55 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Between 55 - 90 years of age, inclusive.
. Immediate family history of Alzheimer's disease.
. Mini-Mental State Exam (MMSE) score of 27 or greater at baseline or expected score range for cognitively normal adjusted for education level.
. Clinical Dementia Rating Global Score of 0 at baseline.
. Delayed Recall score on the Logical Memory IIa subtest of 8 to 15 at baseline or expected score range for cognitively normal adjusted for education level.
. Low serum amyloid levels at baseline.
. Elevated fibrillar amyloid using 11C PiB PET at baseline between 20 - 70 CL.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial uses gamma frequency light and sound stimulation to try to slow amyloid buildup in the brain — since this is listed as Phase NA and not a traditional drug trial, what is currently known about whether this type of stimulation is safe for long-term use, and are there any side effects I should be aware of before considering it?
2The trial is measuring changes in amyloid deposits using PiB PET scans — what does that actually involve, how often would I need to get those scans, and could the radiation exposure from repeated PET scans be a concern for me personally?
3Since this study is enrolling people who are cognitively normal but at risk for Alzheimer's — based on my own family history and risk factors, do you think I would even be a realistic candidate to discuss with the research team?
4Because this is an experimental intervention rather than an established treatment, is there anything I might be missing out on by participating in this study instead of focusing on other proven lifestyle strategies or monitoring approaches you'd recommend for someone in my situation?
5The trial is currently recruiting, which means the approach is still being evaluated — given that we don't yet have results showing whether this actually slows dementia progression, how would you weigh the potential benefit against the time commitment of participating for me specifically?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Changes in brain amyloid deposition over the study period, as measured by PiB PET.
. Willing and able to undergo MRI brain and PET brain scans.
Exclusion criteria
. MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in the eyes, skin, or body.
. High myopia \< -7 diopters, or untreated cataracts that affect vision.
. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
. For subjects agreeing to undergo lumbar punctures, history of bleeding disorders or laboratory results indicating low platelet levels are exclusionary for the procedure.
. Concomitant medications:
. Treatment with NMDA antagonists.
. For subjects undergoing lumbar puncture, current use of warfarin or similar anti-coagulants is exclusionary for the procedure.