REACT: rTMS for Apathy Clinical Trial

• Sponsor: Sunnybrook Health Sciences Centre (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05561205
• Collaborator: (none)
• Enrollment: 8
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 23
• Patients Per Site Per Month: 0.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Alzheimer Disease; Apathy in Dementia	Device: rTMS; Drug: methylphenidate	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 8 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Repetitive Transcranial Magnetic Stimulation for Apathy Clinical Trial (REACT)
• Anticipated Study Start Date: Oct 1, 2022
• Anticipated Primary Completion Date: May 1, 2024
• Anticipated Study Completion Date: Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: rTMS + methylphenidate repetitive transcranial magnetic stimulation (rTMS) and methylphenidate	Device: rTMS; repetitive transcranial magnetic stimulation; Drug: methylphenidate; methylphenidate
Experimental: rTMS only repetitive transcranial magnetic stimulation (rTMS) only	Device: rTMS; repetitive transcranial magnetic stimulation

Outcome Measures

Primary Outcome Measures

1. Apathy Evaluation Scale [2 weeks]

   Measure of apathy on a scale from 18 to 72 with a lower score indicating greater apathy

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sunnybrook Health Sciences Centre	Toronto	Ontario	Canada	M4N 3M5

Sponsors and Collaborators

• Sunnybrook Health Sciences Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sunnybrook Health Sciences Centre
• ClinicalTrials.gov Identifier: NCT05561205
• Other Study ID Numbers: SUN-5342
• First Posted: Sep 30, 2022
• Last Update Posted: Oct 3, 2022
• Last Verified: Sep 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sunnybrook Health Sciences Centre: Apathy; Alzheimer's disease
• Additional relevant MeSH terms: Alzheimer Disease; Methylphenidate

Study Results

No Results Posted as of Oct 3, 2022