Alzheimer's DiseasePhase 2NCT00555204
Safety and Efficacy Study of ABT-089 in Adults With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing ABT-089 in people with Alzheimer's Disease, run by Abbott at 42 sites in United States.
Trial summary
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 337 participants
- Where
- 42 sitesUnited States
- Study dates
- Nov 2007to 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
- Patient has mild to moderate Alzheimer's disease
- Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
- Patient has a MMSE score between 12 and 26
- Patient has a MHIS score of less than or equal to 4
- Females must be postmenopausal for at least two years or surgically sterile
- Patient has an identified, reliable, caregiver who will support him/her to ensure compliance with treatment and will accompany them to each outpatient visit
Who cannot join
- Patient is living in a nursing home
- Patient has a history of any significant neurologic disease other than Alzheimer's disease
- Patient has any uncontrolled medical illness
- Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
Trial locations and contacts
42 sites in 1 country.
42 sites in 1 country
United States42 sites
Study site
Albany, New York, 12208
Study site
Bennington, Vermont, 05201
Study site
Brooksville, Florida, 34613
Study site
Centerville, Ohio, 45459
Study site
Cleveland, Ohio, 44106
Study site
Delray Beach, Florida, 33445
Study site
Fort Myers, Florida, 33901
Study site
Fresno, California, 93720
Study site
Grand Rapids, Michigan, 49503
Study site
Hallendale, Florida, 33009
Study site
Hamden, Connecticut, 06518
Study site
Hialeah, Florida, 33016
Study site
Hickory, North Carolina, 28601
Study site
Indianapolis, Indiana, 46260
Study site
Jenkintown, Pennsylvania, 19046
Study site
Largo, Florida, 33770
Study site
Long Branch, New Jersey, 07740
Study site
Miami, Florida, 33180
Study site
New Haven, Connecticut, 06510
Study site
New York, New York, 10021
Study site
Norristown, Pennsylvania, 19401
Study site
Nutley, New Jersey, 07110
Study site
Paducah, Kentucky, 42003
Study site
Palm Beach Gardens, Florida, 33418
Study site
Phoenix, Arizona, 85006
Study site
Pittsfield, Massachusetts, 01201
Study site
Princeton, New Jersey, 08540
Study site
Ridgewood, New Jersey, 07450
Study site
San Antonio, Texas, 78229
Study site
San Diego, California, 92108
Study site
Santa Ana, California, 92705
Study site
Santa Monica, California, 90404
Study site
St Louis, Missouri, 63141
Study site
Staten Island, New York, 10312
Study site
Sun City, Arizona, 85351
Study site
Sunrise, Florida, 33351
Study site
Tampa, Florida, 33613
Study site
The Bronx, New York, 10454
Study site
West Palm Beach, Florida, 33407
Study site
West Palm Beach, Florida, 33409
Study site
Wichita Falls, Texas, 76309
Study site
Winston-Salem, North Carolina, 27104
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
The purpose of this study is to test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-089, placebo
- Keywords
- mild to moderate Alzheimer's disease, memory, cognition, dementia
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABT-089Drug
10 mg - capsules once daily for 12 weeks
ABT-089Drug
5 mg - capsules once daily for 12 weeks
ABT-089Drug
15 mg - capsules once daily for 12 weeks
ABT-089Drug
20 mg - capsules once daily for 12 weeks
ABT-089Drug
30 mg - capsules once daily for 12 weeks
ABT-089Drug
35 mg - capsules once daily for 12 weeks
placeboDrug
placebo - capsules once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | Not described Receives: Drug: ABT-089 |
| B | Experimental | Not described Receives: Drug: ABT-089 |
| C | Experimental | Not described Receives: Drug: ABT-089 |
| D | Experimental | Not described Receives: Drug: ABT-089 |
| E | Experimental | Not described Receives: Drug: ABT-089 |
| F | Experimental | Not described Receives: Drug: ABT-089 |
| G | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and Tolerability
Measured: Baseline to Final Evaluation
Secondary outcomes (2)
Pharmacokinetics (how the body handles the study drug)
Measured: Baseline to Final Evaluation
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)
Measured: Baseline to Final Evaluation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2007 (estimated)
- Study startNov 2007
- Primary completionJun 2009
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'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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 337 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Robert Lenz, MD, PhD, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555204
- Sponsor's protocol ID
- M06-876
- Status last verified
- Aug 2011
- First submitted
- 7 Nov 2007
- Last updated
- 23 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.
PubMed 25973909
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Study Using a Bayesian Adaptive Design to Evaluate the Efficacy and Safety of ABT-089 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
- ClinicalTrials.gov ID
- NCT00555204
- Acronym / sponsor ID
- M06-876
- Conditions
- Alzheimer's Disease
- Keywords
- mild to moderate Alzheimer's disease, memory, cognition, dementia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 337 participants (actual)
- Lead sponsor
- AbbottIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Primary completion
- Jun 2009 (actual)
- First posted
- 8 Nov 2007 (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 test if the investigational medication ABT-089 is a safe and effective treatment for Alzheimer's disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: ABT-089 |
| B | Experimental | Drug: ABT-089 |
| C | Experimental | Drug: ABT-089 |
| D | Experimental | Drug: ABT-089 |
| E | Experimental | Drug: ABT-089 |
| F | Experimental | Drug: ABT-089 |
| G | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient has mild to moderate Alzheimer's disease
- Patient has been receiving a stable dose of an acetylcholinesterase inhibitor
- Patient has a MMSE score between 12 and 26
- Patient has a MHIS score of less than or equal to 4
- Females must be postmenopausal for at least two years or surgically sterile
Key exclusion criteria (4 listed)
- Patient is living in a nursing home
- Patient has a history of any significant neurologic disease other than Alzheimer's disease
- Patient has any uncontrolled medical illness
- Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence
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-08910 mg - capsules once daily for 12 weeks | Drug | B |
| ABT-0895 mg - capsules once daily for 12 weeks | Drug | A |
| ABT-08915 mg - capsules once daily for 12 weeks | Drug | C |
| ABT-08920 mg - capsules once daily for 12 weeks | Drug | D |
| ABT-08930 mg - capsules once daily for 12 weeks | Drug | E |
| ABT-08935 mg - capsules once daily for 12 weeks | Drug | F |
| placeboplacebo - capsules once daily for 12 weeks | Drug | G |
Primary outcome
Safety and Tolerability
Time frame: Baseline to Final Evaluation
2 secondary outcomes
Pharmacokinetics (how the body handles the study drug)
Time frame: Baseline to Final Evaluation
Pharmacodynamic (how the study drug affects cognitive functions such as thinking and memory)
Time frame: Baseline to Final Evaluation
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 23 Aug 2011.
- Derived from this study: PubMed 25973909Lenz RA, Pritchett YL, Berry SM, Llano DA, Han S, Berry DA, Sadowsky CH, Abi-Saab WM, Saltarelli MD. Adaptive, dose-finding phase 2 trial evaluating the safety and efficacy of ABT-089 in mild to moderate Alzheimer disease. Alzheimer Dis Assoc Disord. 2015 Jul-Sep;29(3):192-9. doi: 10.1097/WAD.0000000000000093.
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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, MD, PhD study director
Abbott
42 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 42 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 6 inclusion and 4 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 23 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 42 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. 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 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 and Tolerability (time frame: Baseline to Final Evaluation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00555204, 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 23 Aug 2011.