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Recruiting NCT05904132

Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

Trial Parameters

Condition Alzheimer Disease
Sponsor Massachusetts General Hospital
Study Type INTERVENTIONAL
Phase N/A
Enrollment 70
Sex ALL
Min Age 50 Years
Max Age 80 Years
Start Date 2025-01-31
Completion 2026-06
Interventions
tACS device

Brief Summary

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. \[exploratory\]

Eligibility Criteria

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)

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