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

Phase 2

• Conditions: Alzheimer's Disease; Apathy
• Interventions: Device: Magnetic Stimulator Magstim Rapid 2; Device: Sham Magnetic Stimulator

• Registration Number: NCT01885806
• Lead Sponsor: Federal University of Minas Gerais

Brief Summary

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

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.

Study Timeline

• Status Verified: 2013-06
• Study Start: 2013-06
• Study First Submitted: 2013-06-18
• Study First Submitted QC: 2013-06-24
• Last Update Submitted: 2013-06-24
• Study First Posted: 2013-06-25
• Last Update Posted: 2013-06-25
• Primary Completion: 2014-12
• Study Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Repetitive TMS	Magnetic Stimulator Magstim Rapid 2	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;
Sham TMS	Sham Magnetic Stimulator	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.

Primary Outcome Measures

Name	Time	Method
Change in apathy symptoms	12 weeks	Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.

Secondary Outcome Measures

Name	Time	Method
Change in ADAS-Cog scores	12 weeks	Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.
Change in the Zarit Burden Scale	12 weeks	Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.

Trial Locations

Locations (1)

Federal University of Minas Gerais; 🇧🇷 Belo Horizonte, Outside of U.S., Brazil