Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease

Study Overview
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Brief Summary
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We aim to evaluate the safety and efficacy of repetitive transcranial magnetic stimulation (rTMS) for apathy treatment in patients with Alzheimer's disease (AD). We hypothesize that rTMS will be superior to placebo to reduce apathy symptoms and severity in patients with AD.

Detailed Description
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This study aims to enroll 40 patients with mild and moderate Alzheimer's disease with apathy symptoms that will be randomized to receive rTMS or sham procedure. Subjects will be randomized in two arms (rTMS or sham procedure) in 1:1 proportion. Eligibility criteria: Diagnosis of Alzheimer's disease, mild and moderate stage (MMSE range from 10 to 20); Diagnosis of apathy; age between 60 and 85 years-old; On stable doses of cholinesterase inhibitors (donepezil, rivastigmine, galantamine) or memantine for at least 6 months prior to enrollment; The primary outcome measures is the Apathy Inventoire. Secondary outcome measures are the NPI score, ADAS-cog scores and the Zarit Burden Scale scores.

Official Title
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Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study

Conditions
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Alzheimer's Disease, Apathy

Intervention / Treatment
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* Device: Magnetic Stimulator Magstim Rapid 2
* Device: Sham Magnetic Stimulator


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 60 to 85 years-old Mild or moderate Alzheimer's disease (MMSE scores between 10 and 20) Apathy diagnosis On stable doses of cholinesterase inhibitors (donepezil, galantamine, rivastigmine) and/or memantine for at least 6 months prior to enrollment Exclusion Criteria: history of epilepsy or convulsions History of migraine or headaches episodes twice per week or more History of neurodegenerative diseases other than Alzheimer's disease Current use of first generation antipsychotics, clozapine, tricyclic drugs or anticonvulsants History of cerebral ischemic episode

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Repetitive TMS<br>Patients will receive 10 consecutive sessions of repetitive transcranial magnetic stimulation with the following protocol: Frequency: 10 Hz Intensity: 90% motor limiar Session duration: 16 minutes (20 sequencies of 6 seconds of stimulation followed by intervals of 30 seconds); Localization: Left pre-frontal dorsolateral cortex; | Device: Magnetic Stimulator Magstim Rapid 2<br>* All procedures will use the Magnetic Stimulator Magstim Rapid 2. Total of session: 10 rTMS protocol: Freqüency: 10 Hz Intensity: 90% limiar motor Session duration: 16 minutes (20 TMS sequences of 6 second with intervals of 30 seconds between each sequence) Location: Left dorsolateral pre-frontal cortex<br>* Other names: rTMS;|
| Sham Comparator: Sham TMS<br>Patients will receive 10 consecutive sessions of sham transcranial magnetic stimulation following the same protocol as the intervention arm, but with no magnetic stimulation of the brain. | Device: Sham Magnetic Stimulator<br>* This intervention will follow the same protocol of the rTMS except that subjects will not receive magnetic stimulation of the brain. Total of session: 10<br>* Other names: Sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in apathy symptoms | Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in ADAS-Cog scores | Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment. | 12 weeks | 
| Change in the Zarit Burden Scale | Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apathy; Alzheimer's disease; Cognition; Burden of Care