Back to resultsrTMS for Apathy Clinical Trial (REACT)
Primary Purpose
Alzheimer Disease, Apathy in Dementia
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
rTMS
methylphenidate
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease focused on measuring Apathy, Alzheimer's disease
Eligibility Criteria
Inclusion Criteria:
- Alzheimer's disease or mixed Alzheimer's disease/vascular disease
- Apathy for at least 4 weeks
- Stable dose of medication (>4 weeks) that may affect cognition or behaviour
- Care partner who spends at least 10 hours a week with the subject
Exclusion Criteria:
- Current major depressive episode
- Agitation, delusions, hallucination
- Medical contraindications to rTMS
- Currently taking an amphetamine product
- Central nervous system abnormalities, Tourette's syndrome, or motor tics
- Current participation in another clinical trial
Sites / Locations
- Sunnybrook Health Sciences CentreRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
rTMS + methylphenidate
rTMS only
Arm Description
repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
repetitive transcranial magnetic stimulation (rTMS) only
Outcomes
Primary Outcome Measures
Apathy Evaluation Scale
Measure of apathy on a scale from 18 to 72 with a lower score indicating greater apathy
Secondary Outcome Measures
Full Information
NCT ID
NCT05561205
First Posted
September 27, 2022
Last Updated
February 10, 2023
Sponsor
Sunnybrook Health Sciences Centre
1. Study Identification
Unique Protocol Identification Number
NCT05561205
Brief Title
rTMS for Apathy Clinical Trial
Acronym
REACT
Official Title
Repetitive Transcranial Magnetic Stimulation for Apathy Clinical Trial (REACT)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 9, 2023 (Actual)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
September 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sunnybrook Health Sciences Centre
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Apathy is a common, early, and disabling symptom in dementias such as Alzheimer's disease (AD) and is characterized by lack of interest and enthusiasm. Both repetitive transcranial magnetic stimulation (rTMS), a form of non-invasive brain stimulation, and methylphenidate, a medication, have been shown to improve apathy. This pilot study will investigate rTMS as a treatment for apathy in AD in individuals receiving methylphenidate and individuals not receiving medication for apathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Apathy in Dementia
Keywords
Apathy, Alzheimer's disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
8 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
rTMS + methylphenidate
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation (rTMS) and methylphenidate
Arm Title
rTMS only
Arm Type
Experimental
Arm Description
repetitive transcranial magnetic stimulation (rTMS) only
Intervention Type
Device
Intervention Name(s)
rTMS
Intervention Description
repetitive transcranial magnetic stimulation
Intervention Type
Drug
Intervention Name(s)
methylphenidate
Intervention Description
methylphenidate
Primary Outcome Measure Information:
Title
Apathy Evaluation Scale
Description
Measure of apathy on a scale from 18 to 72 with a lower score indicating greater apathy
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Alzheimer's disease or mixed Alzheimer's disease/vascular disease
Apathy for at least 4 weeks
Stable dose of medication (>4 weeks) that may affect cognition or behaviour
Care partner who spends at least 10 hours a week with the subject
Exclusion Criteria:
Current major depressive episode
Agitation, delusions, hallucination
Medical contraindications to rTMS
Currently taking an amphetamine product
Central nervous system abnormalities, Tourette's syndrome, or motor tics
Current participation in another clinical trial
Facility Information:
Facility Name
Sunnybrook Health Sciences Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Krushnaa Sankhe
Phone
416-480-6100
Ext
63095
Email
krushnaa.sankhe@sri.utoronto.ca
First Name & Middle Initial & Last Name & Degree
Krista L Lanctôt, PhD
12. IPD Sharing Statement
Learn more about this trial
rTMS for Apathy Clinical Trial
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