Actively Recruiting

Phase Not Applicable
Age: 50Years - 80Years
All Genders
Healthy Volunteers
NCT05904132

Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

Led by Massachusetts General Hospital · Updated on 2025-06-12

70

Participants Needed

1

Research Sites

69 weeks

Total Duration

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AI-Summary

What this Trial Is About

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. \[exploratory\]

CONDITIONS

Official Title

Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

Who Can Participate

Age: 50Years - 80Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Overall cognitive functional status consistent with amnesic MCI (CDR 0.5) likely due to AD (AD biomarker supported)
  • Age between 50 and 80 years
  • Native English speakers
Not Eligible

You will not qualify if you...

  • 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 of alcohol or substance abuse lasting more than 10 years with continuous abuse until symptom onset
  • Contraindications to tACS including scalp lesions or history of seizures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Massachusetts General Hospital

Charlestown, Massachusetts, United States, 02129

Actively Recruiting

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Research Team

D

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CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease | DecenTrialz