Alzheimer s DiseasePhase 2PRIMENCT07279740
Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia
A Phase 2 study testing intermittent theta burst stimulation (iTBS) and Methylphenidate (MPH) in people with Alzheimer s Disease and Alzheimer Dementia (AD), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer s Disease, Alzheimer Dementia (AD), Alzheimer Dementia
- What is being tested?
- intermittent theta burst stimulation (iTBS) and Methylphenidate (MPH)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2026to 1 Oct 2027
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Alzheimer's disease or mixed Alzheimer's disease and vascular disease
- MMSE score 10-28 inclusive
- Clinically significant apathy
- Stable dose of psychotropic medication
- Care partner must spend at least 10hrs/week with the participant
Who cannot join
- Major Depressive Episode
- Clinically significant agitation, delusions, hallucinations
- Currently talking a dopaminergic agent other than methylphenidate
- Failure to clear the TMS adult safety scale (e.g. unapproved pacemakers, metallic implants, history of epilepsy)
- Central nervous system abnormalities (other than Alzheimer's disease) deemed clinically significant by study physician or seizures
- Any condition that in the opinion of the study physician, makes it medically unsafe for the patient to enroll in the trial
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Research Institute
Toronto, Ontario, M4N 3M5
Study Coordinator, 416-480-6100 ext. 63185, memoryresearch@sunnybrook.ca
About this study
Official title: Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders
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
- Conditions
- Alzheimer s Disease, Alzheimer Dementia (AD), Alzheimer Dementia, Alzheimer Disease, Apathy, Apathy in Dementia
- Being tested
- intermittent theta burst stimulation (iTBS), Methylphenidate (MPH)
- Keywords
- apathy, dementia, Alzheimer's disease, methylphenidate, rTMS, iTBS, repetitive transcranial magnetic stimulation, intermittent theta burst stimulation
- Medical subject headings
- Alzheimer Disease, Lethargy, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intermittent theta burst stimulation (iTBS)Device
iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.
Methylphenidate (MPH)Drug
Participants will be on methylphenidate clinically prior to the trial
| Study group | Role | What they receive |
|---|---|---|
| Methylphenidate + iTBS | Experimental | Participants are currently receiving methylphenidate and receive iTBS in this study. Receives: Device: intermittent theta burst stimulation (iTBS); Drug: Methylphenidate (MPH) |
| iTBS only | Experimental | iTBS only, no medication for apathy Receives: Device: intermittent theta burst stimulation (iTBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2025
- Study startJan 2026 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer Society of Canada, Sunnybrook Research Institute, Brain Canada
- Responsible party
- Sponsor
- Investigators
- Krista Lanctot, PhD, Principal investigator, Sunnybrook Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07279740
- Sponsor's protocol ID
- SUN-6831
- Acronym
- PRIME
- Status last verified
- Dec 2025
- First submitted
- 25 Nov 2025
- Last updated
- 12 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided