A Study on Behavioral and Psychological Symptoms of Dementia

NCT00641459 | Completed

• 1 other identifier: CR014665
• Study Type: observational
• Target: 359
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Dementia

Keywords

Behavioral and Psychological Symptoms of Dementia; BPSD; NPI; CGI; MMSE

Outcome Measures

Primary Outcomes (1)

• 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.

  12 weeks

Secondary Outcomes (3)

• CGI (Clinical Global Impression) scores in week 4, week 12, versus in Baseline.

  12 weeks

• MMSE (Minimal Mental Status Examination) scores in week 12 versus in Baseline.

  12 weeks

• NPI (Neuropsychiatric Inventory) scores in week 4, week 12, versus in Baseline.

  12 weeks

Study Arms (1)

001

Other: Observational BPSD treatment study

Interventions

Observational BPSD treatment study OTHER

Observational BPSD treatment study

001

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Taiwan Ltd: lead

MeSH Terms

Conditions

Dementia; Behavior

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Johnson & Johnson Taiwan, Ltd. Clinical Trial

  Johnson & Johnson Taiwan Ltd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: September 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: May 23, 2014

Record last verified: 2014-05