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
- Are there results?
- Not yet: the study is under way
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.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- 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
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders
- ClinicalTrials.gov ID
- NCT07279740
- Acronym / sponsor ID
- PRIME / SUN-6831
- Conditions
- Alzheimer s Disease, Alzheimer Dementia (AD), Alzheimer Dementia, Alzheimer Disease, Apathy, Apathy in Dementia
- Keywords
- apathy, dementia, Alzheimer's disease, methylphenidate, rTMS, iTBS, repetitive transcranial magnetic stimulation, intermittent theta burst stimulation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Alzheimer Society of Canada, Sunnybrook Research Institute, Brain Canada
- Study start
- Jan 2026 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 12 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methylphenidate + iTBS | Experimental | Device: intermittent theta burst stimulation (iTBS), Drug: Methylphenidate (MPH)Participants are currently receiving methylphenidate and receive iTBS in this study. |
| iTBS only | Experimental | Device: intermittent theta burst stimulation (iTBS)iTBS only, no medication for apathy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intermittent theta burst stimulation (iTBS)iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation. | Device | Methylphenidate + iTBS, iTBS only |
| Methylphenidate (MPH)Participants will be on methylphenidate clinically prior to the trial | Drug | Methylphenidate + iTBS |
Primary outcome
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score
Time frame: 2 weeks
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Krista Lanctot, PhD principal investigator
Sunnybrook Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2025.