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

Alzheimer's Disease Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Apathy

• NCT number: NCT01885806
• Study type: Interventional
• Source: Federal University of Minas Gerais
• Contact: Breno S Diniz, MD, PhD
• Phone: +55 31 97950860
• Email: brenosatler@gmail.com
• Status: Recruiting
• Phase: Phase 2
• Start date: June 2013
• Completion date: December 2015