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

NCT ID: NCT01885806

Last Updated: 2013-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2015-12-31

Brief Summary

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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

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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

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Alzheimer's Disease Apathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Repetitive TMS

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;

Group Type EXPERIMENTAL

Magnetic Stimulator Magstim Rapid 2

Intervention Type DEVICE

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 TMS

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.

Group Type SHAM_COMPARATOR

Sham Magnetic Stimulator

Intervention Type DEVICE

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

Interventions

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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

Intervention Type 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

Intervention Type DEVICE

Other Intervention Names

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rTMS Sham

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role lead

Responsible Party

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Breno Satler de Oliveira Diniz

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Breno S Diniz, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of Minas Gerais

Locations

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Federal University of Minas Gerais

Belo Horizonte, Outside of U.S., Brazil

Site Status RECRUITING

Federal University of Minas Gerais

Belo Horizonte, Outside of U.S., Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Breno S Diniz, MD, PhD

Role: CONTACT

+55 31 97950860

Facility Contacts

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Marco A Romano-Silva, MD, PhD

Role: primary

+55 31 3409-9758

Marco A Romano-Silva, MD, PhD

Role: primary

+55 31 3409-9785

Other Identifiers

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CAAE: 15388913.6.0000.5149

Identifier Type: -

Identifier Source: org_study_id

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