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:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2025-12-25 @ 12:16 AM
NCT ID:
NCT00073658
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Alzheimer's type dementia and/or meet criteria for probable or possible Alzheimer's disease
* Inpatient admittance to Western Psychiatric Institute and Clinic
* Written informed consent from participant's legally authorized representative with the participant's assent
* Psychosis or behavioral problems severe enough to be a danger to the participant's health, well-being, or safety
* Score of 3 to 6 (moderate to severe) on at least one of the Neurobehavioral Rating Scale (NBRS) agitation or psychosis items
* Ability to participate in study evaluation and ingest oral medication
Exclusion Criteria:
* Diagnosis of an unstable medical illness within the last 12 months
* Kidney or liver dysfunction
* Diagnosis of delirium, substance-induced persisting dementia, or vascular dementia
* Score of 12 or higher on the Cornell Scale for Depression in Dementia, and a score greater than 3 on the depression item of the NBRS
* Diagnosis of Parkinson's disease or any neurological illness which may affect cognitive function
* History of schizophrenia, schizoaffective disorder, delusional disorder, psychotic disorders not otherwise specified, or bipolar affective disorder
* Alcohol or substance abuse or dependence
* Receiving monoamine oxidase inhibitors within 15 days of study
* Display behaviors which could endanger the participant's life or the lives of others
* Received fluoxetine within 4 weeks of screening
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00073658
Study Brief:
Protocol Section:
NCT00073658