Trials / Completed
CompletedNCT00641459
A Study on Behavioral and Psychological Symptoms of Dementia
Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 359 (actual)
- Sponsor
- Johnson & Johnson Taiwan Ltd · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Observational BPSD treatment study | Observational BPSD treatment study |
Timeline
- Start date
- 2007-09-01
- Primary completion
- 2008-09-01
- Completion
- 2008-09-01
- First posted
- 2008-03-24
- Last updated
- 2014-05-23
Source: ClinicalTrials.gov record NCT00641459. Inclusion in this directory is not an endorsement.