RECRUITINGINTERVENTIONAL

Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

About This Trial

The project is a placebo-controlled study that aims to use closed-loop transcranial alternating current stimulation (tACS) to study patients with symptoms of mild cognitive impairment which is likely due to Alzheimer's disease or another form of dementia (AD-MCI). Patients will undergo an EEG and complete some questionnaires and computer tasks during each study visit. The project has the following aims and hypotheses: 1.) To determine the impact of closed-loop 40 Hz tACS on the entrainment of natural gamma rhythms in patients with AD-MCI, 2.) To determine the impact of closed-loop 40 Hz tACS on cognitive performance in patients with AD-MCI, and 3.) To assess the relationship between baseline neurodegenerative burden and impact of tACS. \[exploratory\]

Who May Be Eligible (Plain English)

Who May Qualify: - Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported) - 50-80 years of age - English native speakers Who Should NOT Join This Trial: - Known presence of a structural brain lesion (e.g., tumor, cortical infarct) - Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure - Active hematological, renal, pulmonary, endocrine or hepatic disorders - 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 - tACS contraindications (lesions in the scalp, history of seizures) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported) * 50-80 years of age * English native speakers Exclusion Criteria: * Known presence of a structural brain lesion (e.g., tumor, cortical infarct) * Acute or decompensated active medical conditions, including cancer, cardiovascular disease, stroke, congestive heart failure * Active hematological, renal, pulmonary, endocrine or hepatic disorders * 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 * tACS contraindications (lesions in the scalp, history of seizures)

Treatments Being Tested

DEVICE

tACS device

you will receive one of four treatment conditions that include active and sham tACS. The four conditions are the following: (1) closed-loop-tACS (peak-locked), (2) closed-loop-tACS (trough-locked), (3) open-loop tACS, and (4) sham tACS. Although each subject will undergo all four treatments in four separate study visits, the order of the treatments will be randomized

Locations (1)

Massachusetts General Hospital

Charlestown, Massachusetts, United States