Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

NCT ID: NCT05904132

Last Updated: 2025-06-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-31
• Study Completion Date: 2026-06-30

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]

Conditions

Alzheimer Disease; Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Healthy Controls

Group Type: PLACEBO_COMPARATOR

tACS device

Intervention Type: 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

MCI Subjects

Group Type: EXPERIMENTAL

tACS device

Intervention Type: 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

Interventions

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

Intervention Type: DEVICE

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)

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Joan A Camprodon, MD MPH PhD

Chief, Division of Neuropsychiatry and Neuromodulation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Joan Camprodon, MD, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

MGH, Division of Neuropsychiatry and Neuromodulation

Locations

Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

DNN Inbox

Role: CONTACT

mghdnn@mgh.harvard.edu

6177265348

Facility Contacts

Joan Camprodon, MD, MPH, PhD

Role: primary

Role: backup

jcamprodon@mgh.harvard.edu

6177265348

Other Identifiers

2023P000785

Identifier Type: -

Identifier Source: org_study_id