NCT01885806

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Federal University of Minas Gerais · Academic / Other
• Sex: All
• Age: 60 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alzheimer's Disease
• Apathy

Interventions

Type	Name	Description
DEVICE	Magnetic Stimulator Magstim Rapid 2	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
DEVICE	Sham Magnetic Stimulator	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

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-12-01
• Completion: 2015-12-01
• First posted: 2013-06-25
• Last updated: 2013-06-25

Locations

2 sites across 1 country: Brazil