Health TrialsbyHealthPanel

Combined Brain Stimulation and Methylphenidate Treatment for Apathy in Dementia

ConditionsAlzheimer s DiseaseAlzheimer Dementia (AD)Alzheimer DementiaAlzheimer DiseaseApathyApathy in Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorSunnybrook Health Sciences Centre

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Alzheimer's disease or mixed Alzheimer's disease and vascular disease

MMSE score 10-28 inclusive

Clinically significant apathy

Stable dose of psychotropic medication

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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

Treatment groups

12 Participants
are divided into 2 treatment groups
Group A: Methylphenidate + iTBSExperimental treatment 2 interventions
Group B: iTBS onlyExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
2 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sunnybrook Health Sciences Centre

Lead sponsor

Alzheimer Society of Canada

Collaborator

Sunnybrook Research Institute

Collaborator

Brain Canada

Collaborator

Source ClinicalTrials.gov
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