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 @ 2:38 PM
Ignite Modification Date:
2025-12-24 @ 2:38 PM
NCT ID:
NCT00641459
Eligibility Criteria:
Inclusion Criteria:
* Patients with the diagnosis of dementia according to DSM-IV (Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) criteria
* Patients meet one of the following types of Dementia: Dementia of the Alzheimer's Type (AD), Vascular Dementia (VaD), Dementia of Lewy Body (DLB), Parkinson's Disease Dementia (PDD)
* Patients have one or more active symptoms of Behavioral and Psychological Symptoms of Dementia (BPSD) on Neuropsychiatric Inventory (NPI) and have not received treatment with antipsychotics, mood stabilizers, or antidepressants within 1 month prior to study entry
* Patients are with caregiver(s) who can give appropriate information about the patients and can assist with the assessment during the study
* Patients (or a legally acceptable representative) have signed the informed consent form
Exclusion Criteria:
* Patients with concurrent other primary major psychiatric disorders (such as Schizophrenia or Bipolar disorder)
* Patients with history of severe allergies or multiple adverse drug reactions
* Patients with history or current symptoms of tardive dyskinesia
* Patients with history of neuroleptic malignant syndrome (NMS)
* Patients who participated in a clinical trial of any investigational drug within 1 month (30 days) prior to study entry
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT00641459
Study Brief:
Protocol Section:
NCT00641459