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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01885806
• Other study ID #: CAAE: 15388913.6.0000.5149
• Status: Recruiting
• Phase: Phase 2
• First received: June 18, 2013
• Last updated: June 24, 2013
• Start date: June 2013
• Est. completion date: December 2015

Study information

• Verified date: June 2013
• Source: Federal University of Minas Gerais
• Contact: Breno S Diniz, MD, PhD
• Phone: +55 31 97950860
• Email: brenosatler[@]gmail.com
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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

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

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Federal University of Minas Gerais	Belo Horizonte	Outside of U.S.
Brazil	Federal University of Minas Gerais	Belo Horizonte	Outside of U.S.

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Safety assessment	Assessment of rTMS safety by the UKU scale.	4th week, 8th week, 12th week	Yes
Primary	Change in apathy symptoms	Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.	12 weeks	No
Secondary	Change in ADAS-Cog scores	Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.	12 weeks	No
Secondary	Change in the Zarit Burden Scale	Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.	12 weeks	No