A Study on Behavioral and Psychological Symptoms of Dementia
The purpose of this observational study is to obtain the current status of patients with Behavioral and Psychological Symptoms of Dementia. This study is also expected to further provide insight into the evolution of behavioral and psychotic symptoms and its relationship with treatment as well as severity of cognitive declines in a naturalistic setting.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study|
- This observational study is to obtain the characteristics, distribution of symptoms, and treatment of patients, including dosages and duration, among subjects with behavioral and psychological symptoms of dementia (BPDS) in a naturalistic setting. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- CGI (Clinical Global Impression) scores in week 4, week 12, versus in Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- MMSE (Minimal Mental Status Examination) scores in week 12 versus in Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- NPI (Neuropsychiatric Inventory) scores in week 4, week 12, versus in Baseline. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||September 2008|
Other: Observational BPSD treatment study
Observational BPSD treatment study
This is an observational, prospective, multi-center study to obtain information about the symptoms and treatment received for patients with behavioral and psychological symptoms of dementia (BPSD). Patients must first meet eligibility criteria and sign informed consent. Patient treatment will be based upon investigator opinion. The following parameters will be assessed: patient's characteristics, Clinical Global Impression (CGI) score, Neuropsychiatric Inventory (NPI), and Minimal Mental Status Examination (MMSE). Each patient will be observed for 12 weeks. Medication dosing regimen will be flexible throughout the study and is based on patient response and investigator judgment. During the study observation period, all patients will attend clinic visits for the subsequent 12 weeks (visit 2 to 3) as is the usual clinical practice. Patients can visit clinics on additional dates as needed or by request. At the pre-planned clinic visits, CGI score, NPI, vital signs, reports of adverse events, drug information, and MMSE score (visit 3) will be recorded. This is an observational study and no study drug is administered.