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Recruiting
NCT05904132
Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
Conditions: Alzheimer Disease, Mild Cognitive Impairment
Sex: All
Ages: 50 Years – 80 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 70
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Charlestown Massachusetts
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)
Source: ClinicalTrials.gov (NCT05904132). StuddyBuddy aggregates publicly available trial information.