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New treatment option for Alzheimer Disease
Official title Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease
ClinicalTrials.gov ID: NCT05776641
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. Gamma waves are important for memory, and in patients with AD, there are fewer gamma waves in the brain.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 55 to 90. Healthy volunteers may be eligible.
You may be able to join if
- 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...
You likely can't join if
- MRI contraindications, such as presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, metal fragments, or foreign objects in...
- 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 people agreeing to undergo lumbar punctures, history of bleeding disorders or laboratory results indicating low platelet levels are exclusionary...
- Concomitant medications:
- Treatment with NMDA antagonists.
See the full eligibility 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.
- Willing and able to undergo MRI brain and PET brain scans.
- Adequate visual and auditory acuity to allow for neuropsychological testing.
- Able to comply with neuropsychological testing and other study procedures in opinion of site PI.
- Willing and able to complete baseline assessments, and willing to participate in 13-month study protocol.
- Willing to provide blood samples at specified timepoints. Willing to consider contributing CSF samples at specified timepoints, if asked.
- 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 people 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 people undergoing lumbar puncture, current use of warfarin or similar anti-coagulants is exclusionary for the procedure.
- Clinical conditions:
- History of seizure or medical diagnosis of epilepsy.
- Female people who are pregnant or currently breastfeeding.
- History of severe allergic or anaphylactic reactions.
- 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.
- Neurodegenerative disorder associated with cognitive impairment.
- Renal disease.
- 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:
- Severe leukoencephalopathy seen on MRI.
- Relevant structural abnormality (i.e., normal pressure or obstructive hydrocephalus, hypoxic ischemic lesions, hemorrhages, tumors, malformations).
- Cerebral amyloid angiopathy, evidenced by T2\ or other susceptibility weighted-MRI.
- Laboratory findings, if known (study does not perform testing) suggestive of systemic illness such as renal disease.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
- 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 listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 55 years to 90 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States; 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.