No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
55 – 90
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
200 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for people aged 55 to 90 with a family history of Alzheimer's disease. Participants will use a special device at home that uses light and sound to boost brain activity and may help prevent dementia.
Are You a Good Fit for This Trial?
Must not be takingWarfarin
Rules you outSeizure disordersRenal disease
You may be able to join if
I am between 55 and 90 years old.
I have a family history of Alzheimer's disease.
I have a Mini-Mental State Exam score of 27 or greater.
I have a Clinical Dementia Rating score of 0.
I have low serum amyloid levels.
I have elevated fibrillar amyloid on a PET scan.
I am willing to undergo MRI and PET scans.
I can comply with study procedures.
You may not be able to join if
I have certain medical implants that make MRI unsafe.
I have untreated vision problems that affect my ability to participate.
I have a significant illness that affects my health.
I have a history of bleeding disorders.
I have epilepsy or a history of seizures.
I am pregnant or breastfeeding.
I have a history of severe allergic reactions.
I have a neurodegenerative disorder affecting my thinking.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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…
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Between 55 - 90 years of age, inclusive.
2. Immediate family history of Alzheimer's disease.
3. Mini-Mental State Exam (MMSE) score of 27 or greater at baseline or expected score range for cognitively normal adjusted for education level.
4. Clinical Dementia Rating Global Sco…
Inclusion Criteria:
1. Between 55 - 90 years of age, inclusive.
2. Immediate family history of Alzheimer's disease.
3. Mini-Mental State Exam (MMSE) score of 27 or greater at baseline or expected score range for cognitively normal adjusted for education level.
4. Clinical Dementia Rating Global Score of 0 at baseline.
5. 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.
6. Low serum amyloid levels at baseline.
7. Elevated fibrillar amyloid using 11C PiB PET at baseline between 20 - 70 CL.
8. Willing and able to undergo MRI brain and PET brain scans.
9. Adequate visual and auditory acuity to allow for neuropsychological testing.
10. Able to comply with neuropsychological testing and other study procedures in opinion of site PI.
11. Willing and able to complete baseline assessments, and willing to participate in 13-month study protocol.
12. Willing to provide blood samples at specified timepoints. Willing to consider contributing CSF samples at specified timepoints, if asked.
Exclusion Criteria:
1. 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.
2. High myopia \< -7 diopters, or untreated cataracts that affect vision.
3. Any significant systemic illness or unstable medical condition which could lead to difficulty complying with the study protocol.
4. For subjects agreeing to undergo lumbar punctures, history of bleeding disorders or laboratory results indicating low platelet levels are exclusionary for the procedure.
5. Concomitant medications:
1. Treatment with NMDA antagonists.
2. For subjects undergoing lumbar puncture, current use of warfarin or similar anti-coagulants is exclusionary for the procedure.
6. Clinical conditions:
1. History of seizure or medical diagnosis of epilepsy.
2. Female subjects who are pregnant or currently breastfeeding.
3. History of severe allergic or anaphylactic reactions.
4. Longstanding premorbid history (i.e., longer than 10 years) of alcohol or substance abuse with continuous abuse up to and including the time that the symptoms leading to clinical presentation developed.
5. Neurodegenerative disorder associated with cognitive impairment.
6. Renal disease.
7. MR imaging findings such as stroke, tumor, leukoencephalopathy that could preclude meaningful analyses of clinical and imaging data in the opinion of the site PI, such as:
1. Severe leukoencephalopathy seen on MRI.
2. Relevant structural abnormality (i.e., normal pressure or obstructive hydrocephalus, hypoxic ischemic lesions, hemorrhages, tumors, malformations).
3. Cerebral amyloid angiopathy, evidenced by T2\* or other susceptibility weighted-MRI.
8. Laboratory findings, if known (study does not perform testing) suggestive of systemic illness such as renal disease.
9. Site investigator's discretion, if s/he feels the subject cannot complete sufficient key study procedures. Exceptions to these guidelines may be considered on a case-by-case basis at the discretion of the Project Director.
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