Alzheimer's DiseasePhase 2NCT00809510
A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study
A Phase 2 study testing ABT-089 in people with Alzheimer's Disease, run by Abbott at 22 sites in United States.
Trial summary
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- ABT-089
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 22 sitesUnited States
- Study dates
- Jan 2009to Jun 2009
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The subject was randomized into Study M06-876 and completed the study.
- The subject must remain on the same dose of AChEI that was used during the M06-876 study.
- The subject is in general good health, as judged by the investigator
Who cannot join
- The subject is currently, or plans to participate in another experimental study during the course of this trial.
- The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Site Reference ID/Investigator# 16509
Bennington, Vermont, 05201
Site Reference ID/Investigator# 16516
Brooksville, Florida, 34601
Site Reference ID/Investigator# 16525
Centerville, Ohio, 45459
Site Reference ID/Investigator# 16510
Deerfield Beach, Florida, 33064
Site Reference ID/Investigator# 16508
Delray Beach, Florida, 33445
Site Reference ID/Investigator# 16527
Eatontown, New Jersey, 07724
Site Reference ID/Investigator# 16524
Fresno, California, 93720
Site Reference ID/Investigator# 16533
Hamden, Connecticut, 06518
Site Reference ID/Investigator# 16526
Indianapolis, Indiana, 46260
Site Reference ID/Investigator# 16515
Miami, Florida, 33180
Site Reference ID/Investigator# 16532
New York, New York, 10021
Site Reference ID/Investigator# 16545
Palm Beach Gardens, Florida, 33418
Site Reference ID/Investigator# 16543
Phoenix, Arizona, 85006
Site Reference ID/Investigator# 16523
Ridgewood, New Jersey, 07450
Site Reference ID/Investigator# 16520
San Diego, California, 92108
Site Reference ID/Investigator# 16521
Santa Monica, California, 90404
Site Reference ID/Investigator# 16528
Sun City, Arizona, 85351
Site Reference ID/Investigator# 16541
Sunrise, Florida, 33351
Site Reference ID/Investigator# 16542
Tampa, Florida, 33613
Site Reference ID/Investigator# 16529
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 16507
Wichita Falls, Texas, 76309
Site Reference ID/Investigator# 16519
Winston-Salem, North Carolina, 27103
About this study
The purpose of this study is to evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-089
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-089Drug
20 mg ABT-089 taken once-daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: ABT-089 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Measured: Month 1, 2, 4, 6
Secondary outcomes (1)
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Measured: Month 1, 2, 4, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Lenz, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00809510
- Sponsor's protocol ID
- M10-745
- Status last verified
- Sep 2011
- First submitted
- 15 Dec 2008
- Last updated
- 2 Sep 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Long-term Safety of ABT-089 for Subjects With Mild-to-moderate Alzheimer's Disease Who Participated in the M06-876 Study
- ClinicalTrials.gov ID
- NCT00809510
- Acronym / sponsor ID
- M10-745
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 63 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Jun 2009 (actual)
- First posted
- 17 Dec 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 evaluate the long-term safety and tolerability of ABT-089 in adults with mild-to-moderate Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: ABT-089 |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The subject was randomized into Study M06-876 and completed the study.
- The subject must remain on the same dose of AChEI that was used during the M06-876 study.
- The subject is in general good health, as judged by the investigator
Key exclusion criteria (2 listed)
- The subject is currently, or plans to participate in another experimental study during the course of this trial.
- The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
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 |
|---|---|---|
| ABT-08920 mg ABT-089 taken once-daily for 6 months | Drug | 1 |
Primary outcome
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time frame: Month 1, 2, 4, 6
1 secondary outcome
ADAS-Cog, CIBIC-plus, MMSE, QoL-AD
Time frame: Month 1, 2, 4, 6
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2011.
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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.
Robert Lenz study director
Abbott
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-089 in people with Alzheimer's Disease, run by Abbott at 22 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 3 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: stopped early, as of the sponsor's last update on 2 Sep 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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. 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?
Safety Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations) (time frame: Month 1, 2, 4, 6). 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 2 Sep 2011.