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

F

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

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

Trial contacts and locations

1

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Central trial contact

Breno S Diniz, MD, PhD

Data sourced from clinicaltrials.gov

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