← Trials/Trial dossier/NCT07279740

PRIME

RecruitingPhase 2

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders

Lead sponsor

Sunnybrook Health Sciences Centre

Asset

Methylphenidate

Listed sites

Recruiting sites

Enrollment

estimated

Study population

Alzheimer’s disease, Vascular cognitive impairment / dementia, Mixed / unspecified dementia

Key I/E criteria

•Multiple dementia etiologies•MMSE 10-28

Primary endpoint

•Neuropsychiatric Inventory (NPI)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT07279740

Org study IDSUN-6831

Timeline

Milestones

Study first posted2025-12-12actual

Last update posted2025-12-12actual

Study start2026-01estimated (month precision)

Primary completion2027-10-01estimated

Study completion2027-10-01estimated

Assets

Drug assets

Methylphenidate

Study populations

Who this study enrolls

Alzheimer’s diseaseVascular cognitive impairment / dementiaMixed / unspecified dementia

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•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

Exclusion criteria

•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

Endpoints (1)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Behavior / neuropsychiatric

1 endpoint

Primary/protocol endpoint

Change in Neuropsychiatric Inventory-Apathy (NPI-A) score

Time frame:2 weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.