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 @ 11:59 PM
Ignite Modification Date:
2025-12-24 @ 11:59 PM
NCT ID:
NCT00249158
Eligibility Criteria:
Inclusion Criteria:
* Dementia of the Alzheimer's type with behavioral disturbance, vascular dementia with behavioral disturbance, or mixed dementia, as classified by DSM-IV (the Diagnostic and Statistical Manual of Mental Diseases, 4th edition)
* a score \>=4 on the FAST (Functional Assessment Staging, a diagnosis tool for determining the stage of dementia) and a score \<=23 on the MMSE (Mini-Mental State Examination, a clinical measure used to evaluate cognition)
* a BEHAVE-AD (Behavior Pathology in Alzheimer's Disease Rating Scale) total score \>=8, and a BEHAVE-AD global rating \>=1
* patient must be living in an nursing home for \>=1 month. Exclusion Criteria:
* Patients with other medical or neurological conditions other than dementia in which cognition is diminished (for example, severe anemia, severe liver, heart, lung, and kidney malfunctions, Parkinson's disease)
* diagnosis of depression within the 6 months before study entry, schizophrenia, bipolar affective disorder, or schizoaffective disorder
* history of or moderate to severe tardive dyskinesia, (a condition of uncontrollable movements of the tongue, lips, face, trunk, hands and feet that is seen in patients receiving long-term medication with certain types of antipsychotic drugs)
* abnormal clinical laboratory test findings.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
55 Years
Study:
NCT00249158
Study Brief:
Protocol Section:
NCT00249158