A Study on Behavioral and Psychological Symptoms of Dementia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier:
NCT00641459
First received: March 17, 2008
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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.


Condition Intervention Phase
Dementia
Other: Observational BPSD treatment study
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Taiwan Ltd:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 359
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
001 Other: Observational BPSD treatment study
Observational BPSD treatment study

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Males or females with diagnosis of dementia according to DSM-IV criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641459

Sponsors and Collaborators
Johnson & Johnson Taiwan Ltd
Investigators
Study Director: Johnson & Johnson Taiwan, Ltd. Clinical Trial Johnson & Johnson Taiwan Ltd
  More Information

No publications provided

Responsible Party: Johnson & Johnson Taiwan Ltd
ClinicalTrials.gov Identifier: NCT00641459     History of Changes
Other Study ID Numbers: CR014665
Study First Received: March 17, 2008
Last Updated: May 22, 2014
Health Authority: Taiwan: Department of Health

Keywords provided by Johnson & Johnson Taiwan Ltd:
Behavioral and Psychological Symptoms of Dementia
BPSD
NPI
CGI
MMSE

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 01, 2014