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

Primary Purpose

Alzheimer's Disease, Apathy

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Magnetic Stimulator Magstim Rapid 2
Sham Magnetic Stimulator
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Apathy; Alzheimer's disease; Cognition; Burden of Care

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Federal University of Minas GeraisRecruiting
  • Federal University of Minas GeraisRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Repetitive TMS

Sham TMS

Arm Description

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;

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Change in ADAS-Cog scores
Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.
Change in the Zarit Burden Scale
Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.

Full Information

First Posted
June 18, 2013
Last Updated
June 24, 2013
Sponsor
Federal University of Minas Gerais
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1. Study Identification

Unique Protocol Identification Number
NCT01885806
Brief Title
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease
Official Title
Repetitive Transcranial Magnetic Stimulation for Apathy Treatment in Alzheimer's Disease: a Randomised, Double-blind, Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2014 (Anticipated)
Study Completion Date
December 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Apathy
Keywords
Apathy; Alzheimer's disease; Cognition; Burden of Care

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Repetitive TMS
Arm Type
Experimental
Arm Description
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;
Arm Title
Sham TMS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Magnetic Stimulator Magstim Rapid 2
Other Intervention Name(s)
rTMS
Intervention Description
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
Intervention Name(s)
Sham Magnetic Stimulator
Other Intervention Name(s)
Sham
Intervention Description
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
Primary Outcome Measure Information:
Title
Change in apathy symptoms
Description
Reduction of 30% in the Apathy Inventoire scores between baseline and 12 weeks after treatment.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Change in ADAS-Cog scores
Description
Improvement in ADAS-Cog scores between baseline and 12 weeks after treatment.
Time Frame
12 weeks
Title
Change in the Zarit Burden Scale
Description
Reduction in the Zarit Burden Scale between baseline and 12 weeks after treatment.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Safety assessment
Description
Assessment of rTMS safety by the UKU scale.
Time Frame
4th week, 8th week, 12th week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Breno S Diniz, MD, PhD
Phone
+55 31 97950860
Email
brenosatler@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Breno S Diniz, MD, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Outside of U.S.
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco A Romano-Silva, MD, PhD
Phone
+55 31 3409-9758
Email
romanosilva@gmail.com
First Name & Middle Initial & Last Name & Degree
Breno S Diniz, MD, PhD
Facility Name
Federal University of Minas Gerais
City
Belo Horizonte
State/Province
Outside of U.S.
ZIP/Postal Code
30130-100
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco A Romano-Silva, MD, PhD
Phone
+55 31 3409-9785
Email
romanosilva@gmail.com
First Name & Middle Initial & Last Name & Degree
Breno S Diniz, MD, PhD

12. IPD Sharing Statement

Learn more about this trial

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

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