RECRUITING

Gamma Light and Sound Stimulation to Prevent Dementia in Cognitively Normal People at Risk for Alzheimer's Disease

Conditions

Alzheimer Disease Family Members Cognitively normal Alzheimer's disease Gamma Amyloid

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Prevention of Alzheimer's Disease Using Gamma Entrainment

Quick Facts

Study Start:2024-01-10

Study Completion:2026-05

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05776641

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:55 Years to 90 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

MJ Quay, MA

CONTACT

617-807-0856

mquay@mgb.org

Gabrielle de Weck, BS

CONTACT

617-258-7723

gdeweck@mit.edu

Principal Investigator

Diane Chan, MD PhD

PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Study Locations (Sites)

Massachusetts General Hospital

Boston, Massachusetts, 02114

United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

Diane Chan, MD PhD, PRINCIPAL_INVESTIGATOR, Massachusetts General Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-01-10

Study Completion Date2026-05

Study Record Updates

Study Start Date2024-01-10

Study Completion Date2026-05

Terms related to this study

Keywords Provided by Researchers

Cognitively normal
Alzheimer's disease
Gamma
Amyloid

Additional Relevant MeSH Terms

Alzheimer Disease
Family Members