Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

Not Applicable

Not yet recruiting

• Conditions: Mild Cognitive Impairment; Alzheimer Disease
• Interventions: Device: tACS device

• Registration Number: NCT05904132
• Lead Sponsor: Massachusetts General Hospital

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. \[exploratory\]

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-22
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-20
• Last Update Posted: 2024-03-22
• Study Start: 2024-07
• Primary Completion: 2025-05
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 70

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Healthy Controls	tACS device	-
MCI Subjects	tACS device	-

Primary Outcome Measures

Name	Time	Method
Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.	After a single stimulation session (30 minutes).	Measured using closed loop 40 Hertz tACS device
Changes in cognitive performance in patients with AD-MCI.	After a single stimulation session (30 minutes).	Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome
Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory]	After a single stimulation session (30 minutes).	Measured using Rey Auditory Verbal Learning Task (RAVLT) which is broken into 6 blocks with each block including a list of 15 words and higher word remembrance in each block indicates a better outcomes, and Face-Name Association Task (FNAT) task where a higher score of matching face to name (out of 60 trials) indicates a better outcome, any MRI/PET scans provided prior to study involvement, and changes in gamma power using closed loop 40 Hertz tACS device

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Charlestown, Massachusetts, United States