Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's TypePhase 3NCT00160147
Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
A Phase 3 study testing bifeprunox in people with Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type, run by Solvay Pharmaceuticals at 51 sites in 5 countries.
Trial summary
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type. Read more about this study
- Who is it for?
- Ages 65 to 90 years
- Conditions the study is for
- Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
- What is being tested?
- bifeprunox
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 51 sitesin 5 countries
- Study dates
- Dec 2005to Jan 2008
- 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 65 to 90 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Diagnosis of dementia of the Alzheimer's type
Who cannot join
- History of seizure disorder
- Clinically significant electrocardiogram (ECG)
- Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma
Trial locations and contacts
51 sites in 5 countries.
51 sites in 5 countries
United States35 sites
Site 934
Atlanta, Georgia
Site 936
Austin, Texas
Site 919
Bedford, Massachusetts
Site 917
Blue Ridge, Georgia
Site 923
Boston, Massachusetts
Site 902
Carson, California
Site 909
Cincinnati, Ohio
Site 928
Dallas, Texas
Site 942
Flowood, Mississippi
Site 929
Hamden, Connecticut
Site 932
Humboldt, Tennessee
Site 903
Long Beach, California
Site 901
Miami, Florida
Site 914
New Britain, Connecticut
Site 904
New Orleans, Louisiana
Site 925
Newnan, Georgia
Site 907
North Miami, Florida
Site 931
Norwalk, Connecticut
Site 908
Oklahoma City, Oklahoma
Site 916
Oklahoma City, Oklahoma
Site 941
Olean, New York
Site 933
Orange City, Florida
Site 911
Pasadena, California
Site 935
Philadelphia, Pennsylvania
Site 912
Phoenix, Arizona
Site 922
San Marino, California
Site 910
Santa Ana, California
Site 905
Shreveport, Louisiana
Site 906
Shreveport, Louisiana
Site 927
St Louis, Missouri
Site 930
St Louis, Missouri
Site 940
St Louis, Missouri
Site 921
Staten Island, New York
Site 918
Waukesha, Wisconsin
Site 913
Williamsburg, Virginia
Israel6 sites
Site 812
Bat Yam
Site 808
Beer Yaakov
Site 811
Hadera
Site 816
Pardes Hana
Site 810
Rehovot
Site 809
Tirat HaCarmel
Czechia5 sites
Site 803
Litoměřice
Site 802
Lnáře
Site 804
Prague
Site 805
Škvorec
Site 801
Tábor
About this study
Official title: A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.
- Being tested
- bifeprunox, Placebo
- Medical subject headings
- Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bifeprunoxDrug
One week titration with dose adjustments
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: bifeprunox |
| 2 | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brief Psychiatric Rating Scale (BPRS) Total Score
Measured: 10 weeks
Secondary outcomes (1)
Adverse events
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2005
- Primary completionJan 2008
- Study completionJan 2008
Why it stopped: The study was discontinued prematurely on 25 February 2008 due to slow enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's TypeStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160147
- Sponsor's protocol ID
- S154.3.016
- Other IDs
- 2005-003475-20, 2005
- Status last verified
- Jun 2009
- First submitted
- 8 Sep 2005
- Last updated
- 9 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-controlled, Efficacy, Safety, and Tolerability Study of Bifeprunox in the Treatment of Elderly Subjects With Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00160147
- Acronym / sponsor ID
- S154.3.016
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was discontinued prematurely on 25 February 2008 due to slow enrollment
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2005
- Primary completion
- Jan 2008 (actual)
- Study completion
- Jan 2008 (actual)
- First posted
- 12 Sep 2005 (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.
This is a 10-week study with bifeprunox and placebo in elderly subjects with psychosis and behavioral disturbances associated with dementia of the alzheimer's type.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: bifeprunox |
| 2 | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 65 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Diagnosis of dementia of the Alzheimer's type
Key exclusion criteria (3 listed)
- History of seizure disorder
- Clinically significant electrocardiogram (ECG)
- Clinical or radiological evidence of stroke, vascular dementia or dementia due to substance abuse, or head trauma
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 |
|---|---|---|
| bifeprunoxOne week titration with dose adjustments | Drug | 1 |
| PlaceboPlacebo | Drug | 2 |
Primary outcome
Brief Psychiatric Rating Scale (BPRS) Total Score
Time frame: 10 weeks
1 secondary outcome
Adverse events
Time frame: 10 weeks
Results and safety
The study was stopped early (reason given: The study was discontinued prematurely on 25 February 2008 due to slow enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2015.
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.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
51 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bifeprunox in people with Psychosis and Behavioral Disturbances Associated With Dementia of the Alzheimer's Type, run by Solvay Pharmaceuticals at 51 sites in 5 countries.
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 1 inclusion and 3 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: stopped early, as of the sponsor's last update on 9 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 51 sites in United States, Israel, Czechia, Poland, Estonia. 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. Some participants in this study may receive a placebo. 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 was stopped early (reason given: The study was discontinued prematurely on 25 February 2008 due to slow enrollment). Results are not available in the source record.
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?
Brief Psychiatric Rating Scale (BPRS) Total Score (time frame: 10 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 9 Feb 2015.