A Phase 2 interventional study of intermittent theta burst stimulation (iTBS) and Methylphenidate (MPH) in Alzheimer s Disease, Alzheimer Dementia (AD) and Alzheimer Dementia, sponsored by Sunnybrook Health Sciences Centre. Recruiting at 1 site in Canada. Per ClinicalTrials.gov, last updated 2025-12-12.
Sponsored by Sunnybrook Health Sciences Centre · Phase 2, Interventional, and Treatment
Among 16 studies in Alzheimer Disease by Sunnybrook Health Sciences Centre — 8 open to participants now, 8 under way, 1 of them phase 3. Alzheimer Disease · Sunnybrook Health Sciences Centre.
Among the 16 studies in Alzheimer Disease by Sunnybrook Health Sciences Centre, this one is the 11th largest by planned enrollment of the 13 interventional ones that give a count, is one of 2 that started in 2026, is one of 5 in phase 2, and was the 16th registered.
3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.
This study's planned enrollment of 12 is below the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →8 of the 16 studies in Alzheimer Disease by Sunnybrook Health Sciences Centre are open now, in 1 country. Each count lists the studies.
Of the 641 Alzheimer Disease studies recruiting now, 283 (44%) set no upper age limit and 54 (8%) stop at 75 or younger; 34 take children under 18; 283 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 6 · Phase 3 3 · Phase 4 2
First in 2003; this study’s year is marked. 2 started in 2026.
Median enrollment 40 across the 13 interventional studies, 345 across the 3 observational. Of the 7 that completed or were terminated, 0 (0%) have results posted.
Sunnybrook Health Sciences Centre is the lead sponsor of 584 studies on the registry; 135 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.
4 of the studies in Alzheimer Disease by Sunnybrook Health Sciences Centre that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04335994Sunnybrook Health Sciences CentreENhancing Outcomes in Cognitive Impairment Through Use of Home Sleep ApNea Testing | 2026-12 |
| NCT05561205Sunnybrook Health Sciences CentrerTMS for Apathy Clinical Trial | 2026-12-01 |
| NCT06014424Sunnybrook Health Sciences CentreCannabidiol Medication Intervention Trial | 2026-12-29 |
| NCT07279740Sunnybrook Health Sciences CentreCombined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia | 2027-10-01 |
Among the 16 studies in Alzheimer Disease by Sunnybrook Health Sciences Centre, from their registry updates:
This study evaluates whether the combined treatment of methylphenidate and non-invasive brain stimulation, called intermittent theta burst stimulation, can effectively treat apathy in individuals with Alzheimer's disease or mixed AD/vascular dementia
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants are currently receiving methylphenidate and receive iTBS in this study.
Device: intermittent theta burst stimulation (iTBS) · Drug: Methylphenidate (MPH)
iTBS only, no medication for apathy
Device: intermittent theta burst stimulation (iTBS)
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Participants will be on methylphenidate clinically prior to the trial
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score
Assesses apathy total (frequency x severity) using the NPI-A based on scores provided by the care-partner through an interview with the assessor. Scores range from 0-12 with a higher score representing worse apathy.
Time frame: 2 weeks
Plan to share: Undecided
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Oct 2027, 21 months later.
Of 127 non-industry phase 2 interventional studies under Alzheimer Disease, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 37 and three quarters within 69. This study's planned 21 months is below that.
Counting every sponsor, half of 257 studies reached it within 37 months; a quarter within 21 and three quarters within 58.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Methylphenidate
Sunnybrook Health Sciences Centre →