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NCT Number: NCT05904132

Individual Closed-Loop Neuromodulation Therapy for Alzheimer's Disease

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]

Recruiting

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Dementia Mental Disorders Mild Cognitive Impairment Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location status: Recruiting

Location contact

Joan Camprodon, MD, MPH, PhD

CONTACT

CONTACT

[email protected]

6177265348

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

tACS device

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

Primary outcomes

  1. Changes in the power of entrainment of natural gamma rhythms in patients with AD-MCI.

    Time frame: After a single stimulation session (30 minutes).

    Measured using closed loop 40 Hertz tACS device

  2. Changes in cognitive performance in patients with AD-MCI.

    Time frame: 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

  3. Changes in gamma power on cognition in patients with AD-MCI including the effect of baseline neurodegenerative burden/biomarkers. [exploratory]

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

DNN Inbox

CONTACT

[email protected]

6177265348

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 15, 2023
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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