NCT05904132 Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease
| NCT ID | NCT05904132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Alzheimer Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 70 participants |
| Start Date | 2025-01-31 |
| Primary Completion | 2027-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 70 participants in total. It began in 2025-01-31 with a primary completion date of 2027-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
Joan Camprodon, MD, PhD, MPH
PRINCIPAL INVESTIGATOR
MGH, Division of Neuropsychiatry and Neuromodulation
Frequently Asked Questions
Who can join the NCT05904132 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 80 Years, studying Alzheimer Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05904132 currently recruiting?
Yes, NCT05904132 is actively recruiting participants. Contact the research team at mghdnn@mgh.harvard.edu for enrollment information.
Where is the NCT05904132 trial being conducted?
This trial is being conducted at Charlestown, United States.
Who is sponsoring the NCT05904132 clinical trial?
NCT05904132 is sponsored by Massachusetts General Hospital. The principal investigator is Joan Camprodon, MD, PhD, MPH at MGH, Division of Neuropsychiatry and Neuromodulation. The trial plans to enroll 70 participants.
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