DementiaPhase 3PAVeDNCT00622128
Preventing Aggressive Behavior in Demented Patients
A Phase 3 study testing Preventing Aggressive Behavior in Demented Patients in people with Dementia and Aggression, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dementia, Aggression
- What is being tested?
- Preventing Aggressive Behavior in Demented Patients
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Oct 2010
- Phase
- Phase 3
- 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
Who may be able to join
- diagnosis of dementia,
- caregiver
Who cannot join
- history of aggression,
- residence of nursing homes
Trial locations and contacts
1 site in 1 country.
United States1 site
Michael E DeBakey VA Medical Center
Houston, Texas, 77030
About this study
The purpose of this study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia.
Read the detailed description
An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed to prevent the incidence of aggression. The investigators have created a manual based on prior work and expert input. Recruitment for pilot patients is now ready to begin. The purpose of the pilot will be to further adapt the intervention, assess feasibility, and examine recruitment options.
- Conditions
- Dementia, Aggression
- Being tested
- Preventing Aggressive Behavior in Demented Patients
- Keywords
- Behavioral Research, Dementia, Aggression
- Medical subject headings
- Dementia, Aggression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Preventing Aggressive Behavior in Demented PatientsBehavioural
Preventing Aggressive Behavior in Demented Patients
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Pilot study. Developing intervention Receives: Behavioral: Preventing Aggressive Behavior in Demented Patients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aggression prevention
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2008 (estimated)
- Study startJun 2009
- Primary completionOct 2010
- Study completionOct 2010
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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- Mark E. Kunik, MD MPH, Principal investigator, Michael E. DeBakey VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00622128
- Sponsor's protocol ID
- MIRECC003
- Acronym
- PAVeD
- Status last verified
- Oct 2010
- First submitted
- 5 Feb 2008
- Last updated
- 18 Oct 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preventing Aggressive Behavior in Demented Patients
- ClinicalTrials.gov ID
- NCT00622128
- Acronym / sponsor ID
- PAVeD / MIRECC003
- Conditions
- Dementia, Aggression
- Keywords
- Behavioral Research, Dementia, Aggression
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jun 2009
- Primary completion
- Oct 2010 (actual)
- Study completion
- Oct 2010 (actual)
- First posted
- 22 Feb 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 study is to develop and pilot test and non-pharmacological intervention designed to prevent the occurence of aggression in persons with dementia.
Detailed description
An expert panel has met to review the investigators' prior work and literature to help create a non-pharmacological intervention designed to prevent the incidence of aggression. The investigators have created a manual based on prior work and expert input. Recruitment for pilot patients is now ready to begin. The purpose of the pilot will be to further adapt the intervention, assess feasibility, and examine recruitment options.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Preventing Aggressive Behavior in Demented PatientsPilot study. Developing intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- diagnosis of dementia,
- caregiver
Key exclusion criteria (2 listed)
- history of aggression,
- residence of nursing homes
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 |
|---|---|---|
| Preventing Aggressive Behavior in Demented PatientsPreventing Aggressive Behavior in Demented Patients | Behavioural | 1 |
Primary outcome
Aggression prevention
Time frame: one year
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 18 Oct 2010.
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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.
Mark E. Kunik, MD MPH principal investigator
Michael E. DeBakey VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Preventing Aggressive Behavior in Demented Patients in people with Dementia and Aggression, run by US Department of Veterans Affairs at 1 site in United States.
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 2 inclusion and 2 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 18 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Aggression prevention (time frame: one year). 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 18 Oct 2010.