A Study on Behavioral and Psychological Symptoms of Dementia

May 22, 2014 updated by: Johnson & Johnson Taiwan Ltd

Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

359

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
001
Other: Observational BPSD treatment study
Observational BPSD treatment study

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
12 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
CGI (Clinical Global Impression) scores in week 4, week 12, versus in Baseline.
Time Frame: 12 weeks
12 weeks
MMSE (Minimal Mental Status Examination) scores in week 12 versus in Baseline.
Time Frame: 12 weeks
12 weeks
NPI (Neuropsychiatric Inventory) scores in week 4, week 12, versus in Baseline.
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Taiwan Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (ACTUAL)

September 1, 2008

Study Completion (ACTUAL)

September 1, 2008

Study Registration Dates

First Submitted

March 17, 2008

First Submitted That Met QC Criteria

March 17, 2008

First Posted (ESTIMATE)

March 24, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 23, 2014

Last Update Submitted That Met QC Criteria

May 22, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR014665

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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