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 @ 12:37 AM
Ignite Modification Date:
2025-12-25 @ 12:37 AM
NCT ID:
NCT00401167
Eligibility Criteria:
Inclusion Criteria:
* Signed informed consent obtained from a legally acceptable representative
* Male or female \> 65 years of age, residing in long-term care
* Diagnosis and Statistical Manual of Mental Disorders (DSM-IV-TR) diagnosis of Dementia of the Alzheimer's type (code 290.1)
* Mini Mental State Examination total score ≤ 15
* Neuropsychiatric Inventory-Nursing Home Version total score \> 10, and a score \> 1 on the agitation/aggression subscale
* A current order for any prescription medication for behavioral and psychological symptoms of dementia (e.g. benzodiazepine, antipsychotic, trazodone), with at least 1 dose used in the prior 3 months
* Patients with a current order for any regularly administered psychotropic (example, selective serotonin reuptake inhibitors, serotonin-norepinephrine reuptake inhibitors, trazodone, atypical antipsychotics, typical antipsychotics or cholinesterase inhibitors) must have been on a stable dose for 3 months prior to entry
Exclusion Criteria:
* Current evidence of any uncontrolled medical illness that would interfere with the subject's participation in the study
* Dementia due to any etiology other than Alzheimer's Disease
* Subjects experiencing significant difficulties ingesting oral medications
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
65 Years
Study:
NCT00401167
Study Brief:
Protocol Section:
NCT00401167