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 @ 7:04 PM
Ignite Modification Date:
2025-12-24 @ 7:04 PM
NCT ID:
NCT02792257
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of Dementia due to AD
2. Presence of Agit-AD as defined by the provisional criteria from the International Psychogeriatric Association (IPA). The definition requires the presence of cognitive impairment, evidence of emotional distress, one of three observable types of behavior (excessive motor activity, verbal aggression, physical aggression), requires that the behavior cause excess disability, and notes that the behaviors cannot be solely attributable to another disorder such as psychiatric illness, medical illness, or effects of substance use.
3. Clinically significant severity of agitation defined by NPI-C Agitation or NPI-C Aggression \> 4.
4. Able to give informed consent, or deemed to lack such capacity by clinical team and legally authorized representative consents.
5. Must be fluent in English and/or Spanish (includes reading, writing, and speech)
6. Must be admitted to clinical sites associated with McLean Hospital, Johns Hopkins University, and Miami Jewish Health Services as an inpatient/long term care resident during the study duration (3 weeks) OR be able to travel to these locations to enroll as an outpatient.
7. Must be 60-95 years old
8. Must begin enrollment in study within one week of being determined eligible
Exclusion Criteria:
1. Serious or unstable medical illness, including cardiovascular, hepatic, renal, respiratory, endocrine, neurologic or hematologic disease, which might confound assessment of safety outcomes.
2. Seizure disorder
3. Baseline delirium as determined by Confusion Assessment Method (CAM) and Diagnostic and Statistical Manual of Mental Disorders (DSM) -5 criteria
4. Current use of lithium
5. Inability to swallow a pill
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
60 Years
Maximum Age:
95 Years
Study:
NCT02792257
Study Brief:
Protocol Section:
NCT02792257