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Non-invasive Brain Stimulation

TMS for Apathy in Alzheimer's Disease

N/A

Recruiting

Led By Mark Eldaief, MD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Clinical diagnosis of Alzheimer's disease, including atypical variants

Prominent symptoms of apathy reported by their primary caregiver/informant and verified with a score of greater than or equal to 45 on the informant version of the Apathy Evaluation Scale (AES-I)

Must not have

Any contraindication to receiving TMS (e.g., a history of seizures, cochlear implants)

Clinical dependence on psychotropic medications believed to affect dopamine binding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 hour

Summary

This trial will show how non-invasive brain stimulation can affect certain brain circuits in patients with apathy due to neurodegenerative diseases. By changing these circuits, there may be improvements in brain activity

Who is the study for?

This trial is for individuals aged 50-80 with Alzheimer's disease, including atypical variants. They must have mild cognitive impairment (MMSE ≥22) and significant apathy symptoms as reported by a caregiver who will accompany them to visits.

What is being tested?

The study tests Intermittent Theta Burst Stimulation (iTBS), a non-invasive brain stimulation technique, to see if it can improve behavior related to apathy in Alzheimer's patients by affecting specific brain circuits.

What are the potential side effects?

While the description doesn't list side effects, iTBS is generally considered safe but may cause discomfort at the stimulation site, headache, lightheadedness or seizures in very rare cases.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with Alzheimer's disease, including any unusual forms.

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My caregiver reports I show strong signs of apathy, confirmed by a high AES-I score.

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I am between 50 and 80 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I do not have a history of seizures or any implants that would interfere with TMS.

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I rely on medication that affects my brain's dopamine levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 hour

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 hour

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 hour for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Changes in dopamine (DA) availability.

Changes in fMRI activation on an apathy related task

Changes in mood scores

+3 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: Ventral circuit (vmPFC) stimulationExperimental Treatment1 Intervention

This arm will involve stimulation of the ventral apathy-relevant circuit. Specifically, a target will be individually selected based on resting-state functional connectivity with a given subject's ventral striatum.

Group II: Dorsal circuit (DLPFC) stimulationExperimental Treatment1 Intervention

This arm will involve stimulation of the dorsal apathy-relevant circuit. Specifically, a target will be individually selected based on resting-state functional connectivity with a given subject's dorsal striatum.

Group III: Sham stimulationPlacebo Group1 Intervention

This arm will involve sham stimulation to a prefrontal target.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Intermittent Theta Burst Stimulation (iTBS)

2022

N/A

~20

0 / 5Eligibility criteria met