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New treatment option for Alzheimer Disease
Official title Chronic Treatment of Alzheimer's Disease by Gamma Light and Sound Therapy
ClinicalTrials.gov ID: NCT05655195
What this study is testing
- What it's testing
- 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. The investigator's 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.
- Time commitment: about 6 months
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 65 to 100. Healthy volunteers may be eligible.
You may be able to join if
- people may be enrolled into the study if they meet all of the following criteria:
- Subject is between the ages of 65 - 100.
- Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26.
- Subject is willing to sign informed consent document.
- If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate...
You likely can't join if
- people who meet any of the following conditions will not be enrolled in the study:
- people who do not have healthcare.
- people who are currently taking amyloid reducing therapy.
- people who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
- Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose...
- people who are actively diagnosed with cancer and undergoing cancer-related treatments
See the full eligibility criteria
- people may be enrolled into the study if they meet all of the following criteria:
- Subject is between the ages of 65 - 100.
- Subject must have mild Alzheimer's disease with a Mini Mental State Exam (MMSE) score of 19-26.
- Subject is willing to sign informed consent document.
- If subject is deemed to not have capacity to sign the informed consent, he/she will need a legally authorized representative to provide surrogate consent.
- Able to complete the 1st month of at home stimulation at their primary residence. If people plan to spend more than 1 week away from their primary residence during the trial, their inclusion must be assessed by the...
- people who meet any of the following conditions will not be enrolled in the study:
- people who do not have healthcare.
- people who are currently taking amyloid reducing therapy.
- people who have \> 4 cerebral microbleeds or 1 macrobleed in their brain
- Active treatment on a dosage of one or more psychiatric agents (e.g. antidepressants, antipsychotics, etc) for LESS THAN three months (a stable dose for greater than or equal to three months is ok).
- people who are actively diagnosed with cancer and undergoing cancer-related treatments
- people who are being treated with N-methyl-D-aspartate (NMDA) receptor antagonists (eg. Memantine).
- people on medications that lower seizure threshold such as wellbutrin, ciprofloxacin, levofloxacin, etc.
- people with history of seizure or epilepsy
- people with clinically significant suicide risk and/or suicide attempt in the past 1 year.
- people with behavioral problems such as aggression/agitation/impulsivity that might interfere with their ability to comply with protocol.
- people with untreated or unstable depression
- Active treatment with one or more anti-epileptic agent.
- people who have had a stroke within the past 24 months.
- people who have had eye surgery in the last 3 months or are scheduled to have eye surgery in the next 6 months (during the study)
- people diagnosed with migraine headache.
- people who have an active implantable medical device including but not limited to implantable cardioverter defibrillator (ICD), deep brain stimulator (DBS), cardiac pacemaker, and/or sacral nerve stimulator.
- people who have profound hearing or visual impairment.
- people who have a life expectancy of less than 2 years.
- people who are pregnant.
- Current or past history of any neurological disorder other than dementia, such as epilepsy, stroke, progressive neurologic disease (e.g. multiple sclerosis) or intracranial brain lesions; and history of previous...
The study team makes the final eligibility decision.
Where it's taking place
- Cambridge, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 6 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 65 years to 100 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cambridge, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.