Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Alzheimer's Disease
- Sponsor
- Federal University of Minas Gerais
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change in apathy symptoms
- Last Updated
- 12 years ago
Overview
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.
Investigators
Breno Satler de Oliveira Diniz
Assistant Professor
Federal University of Minas Gerais
Eligibility Criteria
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
Outcomes
Primary Outcomes
Change in apathy symptoms
Time Frame: 12 weeks
Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.
Secondary Outcomes
- Change in ADAS-Cog scores(12 weeks)
- Change in the Zarit Burden Scale(12 weeks)