Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2025-12-24 @ 3:33 PM
NCT ID:
NCT03846492
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT03846492
Study Brief:
Protocol Section:
NCT03846492