DementiaNCT00641459
A Study on Behavioral and Psychological Symptoms of Dementia
An observational study of Dementia, run by Johnson & Johnson Taiwan Ltd.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia
- What is being tested?
- Observational BPSD treatment study
- How many people
- 359 participants
- Where
- No sites listed yet
- Study dates
- Sep 2007to Sep 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Males or females with diagnosis of dementia according to DSM-IV criteria
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
Read the 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
- Dementia
- Being tested
- Observational BPSD treatment study
- Keywords
- Behavioral and Psychological Symptoms of Dementia, BPSD, NPI, CGI, MMSE
- Medical subject headings
- Dementia, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational BPSD treatment studyOther
Observational BPSD treatment study
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Other: Observational BPSD treatment study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (3)
CGI (Clinical Global Impression) scores in week 4, week 12, versus in Baseline.
Measured: 12 weeks
MMSE (Minimal Mental Status Examination) scores in week 12 versus in Baseline.
Measured: 12 weeks
NPI (Neuropsychiatric Inventory) scores in week 4, week 12, versus in Baseline.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startSep 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 359 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Taiwan Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Johnson & Johnson Taiwan, Ltd. Clinical Trial, Study director, Johnson & Johnson Taiwan Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641459
- Sponsor's protocol ID
- CR014665
- Status last verified
- May 2014
- First submitted
- 17 Mar 2008
- Last updated
- 23 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behavioral and Psychological Symptoms of Dementia (BPSD) in Taiwan - An Observational Study
- ClinicalTrials.gov ID
- NCT00641459
- Acronym / sponsor ID
- CR014665
- Conditions
- Dementia
- Keywords
- Behavioral and Psychological Symptoms of Dementia, BPSD, NPI, CGI, MMSE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 359 participants (actual)
- Lead sponsor
- Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
- Study start
- Sep 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Other: Observational BPSD treatment study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Males or females with diagnosis of dementia according to DSM-IV criteria
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Observational BPSD treatment studyObservational BPSD treatment study | Other | 001 |
Primary outcome
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
3 secondary outcomes
CGI (Clinical Global Impression) scores in week 4, week 12, versus in Baseline.
Time frame: 12 weeks
MMSE (Minimal Mental Status Examination) scores in week 12 versus in Baseline.
Time frame: 12 weeks
NPI (Neuropsychiatric Inventory) scores in week 4, week 12, versus in Baseline.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johnson & Johnson Taiwan, Ltd. Clinical Trial study director
Johnson & Johnson Taiwan Ltd
Questions about this trial
What is this clinical trial studying?
An observational study of Dementia, run by Johnson & Johnson Taiwan Ltd.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2014.