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 @ 9:08 PM
Ignite Modification Date:
2025-12-24 @ 9:08 PM
NCT ID:
NCT00009204
Eligibility Criteria:
Inclusion Criteria:
* Meets DSM-IV criteria for diagnosis of dementia of the Alzheimer's type (AD), Vascular dementia (VD), mixed (AD and VD) or dementia NOS (Not Otherwise Specified)
* Presents with psychosis or behavioral problems severe enough to endanger the patient's health, well-being or safety, as evidenced by a score of at least 3 (moderate) on one of the Neurobehavioral Rating Scale (NBRS) agitation items (8,11,14) or psychosis items (16,18,20) and are not secondary to physical illness nor amenable to environmental optimization
* Able to participate in study evaluations and ingest oral medication
* Has next of kin or a guardian available to consent to patient's participation.
Exclusion Criteria:
* Has an unstable medical illness including significant cardiac (specifically bradycardia with ventricular rate below 50), renal, hepatic, or neurological illness (especially Parkinson's disease) other than dementia
* Meets DSM-IV criteria for Delirium upon admission to Western Psychiatric Institute and Clinic
* Has been medicated within 4 weeks of protocol admission with fluoxetine or 2 weeks with a monoamine oxidase inhibitor (patients will undergo a monitored psychotropic drug washout prior to entering the protocol)
* Is currently being treated with cognitive enhancing drugs (Tacrine or Aricept) or any experimental drug
* Has a concurrent diagnosis of schizophrenia, bipolar disorder, or major depression
* Has preexisting orthostatic hypotension (with \> 20 mmHg change from sitting to standing pressure)
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00009204
Study Brief:
Protocol Section:
NCT00009204