NCT03846492 · ACTIVE NOT RECRUITING

Targeting Brain Physiology to Treat Neuropsychiatric Symptoms of Dementia Using TMS-EEG and tDCS

This trial is testing whether a non-invasive brain stimulation technique called tDCS (which delivers a mild electrical current through the scalp) can reduce agitation and aggression in people living with Alzheimer's dementia. A separate brain-mapping method, TMS-EEG, is used to study why agitation happens in the first place. This is a Phase NA (exploratory) study — it is investigating mechanisms and early effectiveness, not a proven or approved treatment.

Eligibility criteria

Participants with AD+Agitation
Inclusion:
1. Age 50 years or older.
2. Participant or substitute decision maker able and willing to provide informed consent.
3. Dementia due to probable or possible AD as defined by NIA-AA criteria.
4. 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.
5. Availability of a support person to accompany the participant to study appointments and provide collateral information as needed.
6. If taking medication for neuropsychiatric symptoms, the dose should be stable for at least 1 week.
Exclusion:
1. Psychiatric diagnosis other than dementia significantly impacting the presentation.
2. Presence of delirium or other acute medical condition significantly contributing to agitation/aggression or making the study participation unsafe for a participant.
3. Any contraindication to TMS or tDCS.
4. Any other condition that in the opinion of principal investigator will make the study participation unsafe or non-feasible for the participant.
5. 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:
1. Age 50 years or older.
2. Able and willing to provide informed consent.
3. Free from any significant neurological disorder.
Exclusion:
1. Lifetime DSM-5 diagnosis other than simple phobias or adjustment disorder.
2. Any Contraindication to TMS.
3. Currently taking anticonvulsants or benzodiazepines at a dose sufficient to cause interference with TMS-EEG.

The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.

Eligibility criteria as of 2026-04-13

View full record on ClinicalTrials.gov

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