Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

Methylphenidate Primed iTBS for Apathy in Neurocognitive Disorders

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07279740

Acronym

PRIME

Enrollment

Registered

2025-12-12

Start date

2026-01-31

Completion date

2027-10-01

Last updated

2025-12-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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

Brief 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

Interventions

DEVICEintermittent theta burst stimulation (iTBS)

iTBS is a form of repetitive transcranial magnetic simulation (rTMS), a non-invasive form of brain stimulation.

DRUGMethylphenidate (MPH)

Participants will be on methylphenidate clinically prior to the trial

Study design

Allocation

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in Neuropsychiatric Inventory-Apathy (NPI-A) score	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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026