Ignite Creation Date:
2025-12-24 @ 2:38 PM
Ignite Modification Date:
2026-02-01 @ 7:54 PM
Study NCT ID:
NCT00641459
Status:
COMPLETED
Last Update Posted:
2014-05-23
First Post:
2008-03-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study on Behavioral and Psychological Symptoms of Dementia
Sponsor:
Johnson & Johnson Taiwan Ltd
Organization:
Study Overview
Official Title:
Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study
Status:
COMPLETED
Status Verified Date:
2014-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: