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

Federal University of Minas Gerais

Status and phase: Unknown; Phase 2

Conditions: Apathy; Alzheimer's Disease

Treatments: Device: Sham Magnetic Stimulator; Device: Magnetic Stimulator Magstim Rapid 2

Study type: Interventional

Funder types: Other

Identifiers

NCT01885806

CAAE: 15388913.6.0000.5149

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 60 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Triple Blind

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40 participants in 2 patient groups

Repetitive TMS

Experimental group

Description:

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;

Treatment:

Device: Magnetic Stimulator Magstim Rapid 2

Sham TMS

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Magnetic Stimulator