Recruiting

rTMS with Methylphenidate

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT05561205

Conditions

Alzheimer Disease

Apathy in Dementia

Dementia

Mild Behavioural Impairment

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

rTMS

methylphenidate

Study Details

Brief summary:

Apathy is a common, early, and disabling symptom in dementias and mild behavioural impairment 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 neurocognitive disorders and mild behavioural impairment in individuals receiving methylphenidate and individuals not receiving medication for apathy.

Conditions

Alzheimer Disease

Apathy in Dementia

Dementia

Mild Behavioural Impairment

Mild Cognitive Impairment

Study ID

NCT05561205

Start date

Feb 9, 2023

Status verified date

Apr, 2026

Completion date

Dec 1, 2026

Anticipated

Primary completion date

Dec 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • mild or major neurocognitive disorder OR mild behavioural impairment
  • 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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: rTMS + methylphenidate

repetitive transcranial magnetic stimulation (rTMS) and methylphenidate

experimental: rTMS only

repetitive transcranial magnetic stimulation (rTMS) only

Interventions

rTMS

repetitive transcranial magnetic stimulation

methylphenidate

methylphenidate

Primary outcome measure

  • Neuropsychiatric Inventory-apathy [ Time Frame: 2 weeks ]

Central Contacts and Locations

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Carla Zucchero-Sarracini

416-480-6100memoryresearch@sunnybrook.ca

Principal Investigator:

Krista L Lanctôt, PhD

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Apr 13, 2026

Last verified

Apr, 2026

Keywords

  • Apathy
  • Alzheimer's disease
  • Neurocognitive disorder
  • Mild behavioural impairment

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2026-04-13.