NCT07279740

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_2

Timeline
15mo left

Started Jan 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress26%
Jan 2026Oct 2027

First Submitted

Initial submission to the registry

November 25, 2025

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 12, 2025

Completed
20 days until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

1.7 years

First QC Date

November 25, 2025

Last Update Submit

December 11, 2025

Conditions

Alzheimer s DiseaseAlzheimer Dementia (AD)Alzheimer DementiaAlzheimer DiseaseApathyApathy in Dementia

Keywords

apathydementiaAlzheimer's diseasemethylphenidaterTMSiTBSrepetitive transcranial magnetic stimulationintermittent theta burst stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 weeks

Study Arms (2)

Methylphenidate + iTBS

EXPERIMENTAL

Participants are currently receiving methylphenidate and receive iTBS in this study.

Device: intermittent theta burst stimulation (iTBS)Drug: Methylphenidate (MPH)

iTBS only

EXPERIMENTAL

iTBS only, no medication for apathy

Device: intermittent theta burst stimulation (iTBS)

Interventions

intermittent theta burst stimulation (iTBS)DEVICE

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

Methylphenidate + iTBSiTBS only
Methylphenidate (MPH)DRUG

Participants will be on methylphenidate clinically prior to the trial

Methylphenidate + iTBS

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Research Institute

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

MeSH Terms

Conditions

Alzheimer DiseaseLethargyDementia

Interventions

Methylphenidate

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylacetatesAcids, CarbocyclicCarboxylic AcidsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Krista Lanctot, PhD

    Sunnybrook Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 25, 2025

First Posted

December 12, 2025

Study Start

January 1, 2026

Primary Completion (Estimated)

October 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

CA(1)