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

Sponsor
Federal University of Minas Gerais (Other)
Overall Status
Unknown status
CT.gov ID
NCT01885806
Collaborator
(none)
40
Enrollment
2
Locations
2
Arms
30
Duration (Months)
20
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Magnetic Stimulator Magstim Rapid 2
  • Device: Sham Magnetic Stimulator
 Phase 2

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
Study Start Date :
Jun 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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;

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
Other Names:
  • rTMS

    		•
    Sham Comparator: 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.

    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
    Other Names:
  • Sham

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in apathy symptoms [12 weeks]

      Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.

    Secondary Outcome Measures

    1. Change in ADAS-Cog scores [12 weeks]

      Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.

    2. Change in the Zarit Burden Scale [12 weeks]

      Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.

    Other Outcome Measures

    1. Safety assessment [4th week, 8th week, 12th week]

      Assessment of rTMS safety by the UKU scale.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    60 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Federal University of Minas Gerais Belo Horizonte Outside of U.S. Brazil 30130-100
    2 Federal University of Minas Gerais Belo Horizonte Outside of U.S. Brazil 30130-100

    Sponsors and Collaborators

    • Federal University of Minas Gerais

    Investigators

    • Principal Investigator: Breno S Diniz, MD, PhD, Federal University of Minas Gerais

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Breno Satler de Oliveira Diniz, Assistant Professor, Federal University of Minas Gerais
    ClinicalTrials.gov Identifier:
    NCT01885806
    Other Study ID Numbers:
    • CAAE: 15388913.6.0000.5149
    First Posted:
    Jun 25, 2013
    Last Update Posted:
    Jun 25, 2013
    Last Verified:
    Jun 1, 2013
    Keywords provided by Breno Satler de Oliveira Diniz, Assistant Professor, Federal University of Minas Gerais
    Apathy; Alzheimer's disease; Cognition; Burden of Care
    Additional relevant MeSH terms:
    Alzheimer Disease

    Study Results

    No Results Posted as of Jun 25, 2013