Status:
RECRUITING
Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS
Lead Sponsor:
Centre for Addiction and Mental Health
Collaborating Sponsors:
BrightFocus Foundation
Conditions:
Alzheimer Disease
Dementia, Mixed
Eligibility:
All Genders
50+ years
Phase:
NA
Brief Summary
Agitation and aggression impose a tremendous burden on the individuals living with dementia, their families, caregivers, and healthcare systems. Neuropsychiatric symptoms of dementia (NPS) affect up t...
Detailed Description
Alzheimer's dementia (AD) and related neurodegenerative diseases are inflicting a global healthcare crisis. Neuropsychiatric symptoms including agitation and aggression affect up to 80% of patients wi...
Eligibility Criteria
Inclusion
- Participants with AD+Agitation
- Inclusion:
- Age 50 years or older.
- Participant or substitute decision maker able and willing to provide informed consent.
- Dementia due to probable or possible AD as defined by NIA-AA criteria.
- Presence of mild to moderate agitation and/or aggression as defined by: Agitation in cognitive disorders. International Psychogeriatric Association Provisional Consensus Clinical and Research Definition.
- Availability of a support person to accompany the participant to study appointments and provide collateral information as needed.
- If taking medication for neuropsychiatric symptoms, the dose should be stable for at least 1 week.
- Exclusion:
- Psychiatric diagnosis other than dementia significantly impacting the presentation.
- Presence of delirium or other acute medical condition significantly contributing to agitation/aggression or making the study participation unsafe for a participant.
- Any contraindication to TMS or tDCS.
- Any other condition that in the opinion of principal investigator will make the study participation unsafe or non-feasible for the participant.
- Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG.
- Participants with AD without aggression
- All the above inclusion/exclusion criteria except meeting the inclusion criterion 4 pertaining to agitation/aggression. Participants with significant agitation/aggression will be excluded from this group.
- Healthy comparator participants
- Inclusion:
- Age 50 years or older.
- Able and willing to provide informed consent.
- Free from any significant neurological disorder.
- Exclusion:
- Lifetime DSM-5 diagnosis other than simple phobias or adjustment disorder.
- Any Contraindication to TMS.
- Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG.
Exclusion
Key Trial Info
Start Date :
April 24 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2025
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT03846492
Start Date
April 24 2019
End Date
June 1 2025
Last Update
February 28 2024
Active Locations (1)
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1
Centre for Addiction and Mental Health
Toronto, Ontario, Canada, M6J 1H4