Alzheimer DiseasePhase 3NCT00036114
Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
A Phase 3 study testing aripiprazole in people with Alzheimer Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 41 sites in United States.
Trial summary
The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type. Read more about this study
- Who is it for?
- Ages 55 to 95 years
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- aripiprazole
- How many people
- Not given
- Where
- 41 sitesUnited States
- Study dates
- Mar 2000to Aug 2003
- 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 55 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Institutionalized patients with Alzheimer's
Who cannot join
None listed.
Trial locations and contacts
41 sites in 1 country.
41 sites in 1 country
United States41 sites
Local Institution
Albany, New York
Local Institution
Atlanta, Georgia
Local Institution
Augusta, Georgia
Local Institution
Austin, Texas
Local Institution
Baltimore, Maryland
Local Institution
Beachwood, Ohio
Local Institution
Bennington, Vermont
Local Institution
Cerritos, California
Local Institution
Charlottesville, Virginia
Local Institution
Dallas, Texas
Local Institution
Denver, Colorado
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Granada Hills, California
Local Institution
Hamden, Connecticut
Local Institution
Hershey, Pennsylvania
Local Institution
Honolulu, Hawaii
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Lawrence, New York
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Los Angeles, California
Local Institution
Lyons, New Jersey
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Macon, Georgia
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Miami, Florida
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Montrose, New York
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New Orleans, Louisiana
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Newton Center, Massachusetts
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North Chicago, Illinois
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North Miami Beach, Florida
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Northport, New York
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Portland, Oregon
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Raleigh, North Carolina
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San Antonio, Texas
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San Diego, California
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Scottsdale, Arizona
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Seattle, Washington
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Shreveport, Louisiana
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Springfield, Illinois
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Springfield, Massachusetts
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Torrance, California
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Tuscaloosa, Alabama
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Wellesley Hills, Massachusetts
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West Palm Beach, Florida
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White Plains, New York
Local Institution
Wichita Falls, Texas
About this study
The purpose of this study is to learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.
- Conditions
- Alzheimer Disease
- Being tested
- aripiprazole
- Keywords
- Psychosis associated with dementia of the Alzheimer's type
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aripiprazoleDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2002 (estimated)
- Study startMar 2000
- Primary completionAug 2003
- Study completionAug 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- More trials run by Otsuka Pharmaceutical Development & Commercialization, Inc.The sponsor's other registered studies.
- 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
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00036114
- Sponsor's protocol ID
- CN138-004
- Status last verified
- Apr 2011
- First submitted
- 7 May 2002
- Last updated
- 11 Nov 2013
- Results posted
- No
Publications
Muhlbauer V, Mohler R, Dichter MN, Zuidema SU, Kopke S, Luijendijk HJ. Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.
PubMed 34918337
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Aripiprazole in the Treatment of Patients With Psychosis Associated With Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00036114
- Acronym / sponsor ID
- CN138-004
- Conditions
- Alzheimer Disease
- Keywords
- Psychosis associated with dementia of the Alzheimer's type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Otsuka Pharmaceutical Development & Commercialization, Inc.Industry (pharma, biotech, devices)
- Study start
- Mar 2000
- Primary completion
- Aug 2003 (actual)
- Study completion
- Aug 2003 (actual)
- First posted
- 9 May 2002 (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 learn if aripiprazole is safe and effective in the treatment of psychosis associated with dementia of the Alzheimer's type.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 55 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Institutionalized patients with Alzheimer's
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| aripiprazole | Drug | – |
Primary outcome
Not reported in the source record.
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 11 Nov 2013.
- Derived from this study: PubMed 34918337Muhlbauer V, Mohler R, Dichter MN, Zuidema SU, Kopke S, Luijendijk HJ. Antipsychotics for agitation and psychosis in people with Alzheimer's disease and vascular dementia. Cochrane Database Syst Rev. 2021 Dec 17;12(12):CD013304. doi: 10.1002/14651858.CD013304.pub2.
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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.
The record lists no contact. Use the official record to reach the sponsor.
41 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing aripiprazole in people with Alzheimer Disease, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 41 sites 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 1 inclusion and 0 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 11 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00036114, which also lists 1 linked publication.
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 11 Nov 2013.