Alzheimer's DiseasePhase 2NCT01690195
Safety and Tolerability Study Evaluating a New Treatment for Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 39 sites in 7 countries.
Trial summary
This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors. 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-126
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 343 participants
- Where
- 39 sitesin 7 countries
- Study dates
- Sep 2012to Feb 2014
- 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 and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
- The subject was randomized into Study M11-793 and completed dosing through Week 24 in that study.
- With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
- If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least two years or is surgically sterile, then use of a barrier method of birth control is not required.
- The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.
- The subject and caregiver must have sufficient visual, hearing and graphomotor skills to complete the study procedures.
Who cannot join
- The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 that indicates the subject could become medically unstable during the current study.
- The subject is currently taking or is expected to be prescribed any excluded medications without the approval of Abbott medical monitor.
- The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study.
- The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
- The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial.
- The subject developed any significant medical or psychiatric condition that, in the opinion of the investigator, renders the subject an unsuitable candidate to participate in this study.
- For any other reason the investigator considers the subject to be an unsuitable candidate to receive ABT-126 or to participate in this study.
Trial locations and contacts
39 sites in 7 countries.
39 sites in 7 countries
United States9 sites
Site Reference ID/Investigator# 84179
Bennington, Vermont, 05201
Site Reference ID/Investigator# 84178
Delray Beach, Florida, 33445
Site Reference ID/Investigator# 84182
Elk Grove Village, Illinois, 60007
Site Reference ID/Investigator# 84187
Hamden, Connecticut, 06518
Site Reference ID/Investigator# 84185
Long Beach, California, 90806
Site Reference ID/Investigator# 84180
Orlando, Florida, 32806
Site Reference ID/Investigator# 84183
San Francisco, California, 94109-4841
Site Reference ID/Investigator# 84181
Staten Island, New York, 10312
Site Reference ID/Investigator# 84186
West Palm Beach, Florida, 33407
Germany6 sites
Site Reference ID/Investigator# 84382
Berlin, 14050
Site Reference ID/Investigator# 84380
Freiburg im Breisgau, 79106
Site Reference ID/Investigator# 84383
Hüttenberg, 35625
Site Reference ID/Investigator# 84379
Mittweida, 09648
Site Reference ID/Investigator# 84381
Munich, 81675
Site Reference ID/Investigator# 84378
Schwerin, 19053
Canada5 sites
Site Reference ID/Investigator# 84173
Gatineau, J9A 1K7
Site Reference ID/Investigator# 84174
Montreal, H3T 1E2
Site Reference ID/Investigator# 84177
Peterborough, K9H 2P4
Site Reference ID/Investigator# 84175
Toronto, M3B 2S7
Site Reference ID/Investigator# 84176
Verdun, H4H 1R3
France5 sites
Site Reference ID/Investigator# 84376
Dijon, 21033
Site Reference ID/Investigator# 84373
Limoges, 87042
Site Reference ID/Investigator# 84377
Paris, 75013
Site Reference ID/Investigator# 84374
Paris, 75475
Site Reference ID/Investigator# 84375
Toulouse, 31059
Greece5 sites
Site Reference ID/Investigator# 84385
Athens, 115 21
Site Reference ID/Investigator# 84388
Athens, 151 25
Site Reference ID/Investigator# 84389
Athens, 15123
Site Reference ID/Investigator# 84386
Haidari, Athens, 12462
Site Reference ID/Investigator# 84390
Thessaloniki, 570 10
South Africa5 sites
Site Reference ID/Investigator# 84395
Belville, 7530
Site Reference ID/Investigator# 84391
Cape Town, 7405
Site Reference ID/Investigator# 84393
George, 6529
Site Reference ID/Investigator# 84394
Johannesburg, 2196
Site Reference ID/Investigator# 84392
Rosebank, 2196
United Kingdom4 sites
Site Reference ID/Investigator# 84398
Bath, BA1 3NG
Site Reference ID/Investigator# 84397
Glasgow, G20 0XA
Site Reference ID/Investigator# 84400
London, TW8 8DS
Site Reference ID/Investigator# 84399
Manchester, M8 5RB
About this study
Official title: Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793
This is a long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
Read the detailed description
This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-126
- 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-126Drug
See arm description
| Study group | Role | What they receive |
|---|---|---|
| ABT-126 | Experimental | ABT-126 Open-label dose Receives: Drug: ABT-126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse Events
Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
Measured: Assessments up through 28 weeks
Laboratory Data
Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Measured: Assessments up through 28 weeks
Vital Signs
Assessments include pulse, blood pressure and oral body temperature
Measured: Assessments up through 28 weeks
Physical examinations
An examination of bodily functions and physical condition
Measured: Assessments up through 28 weeks
Brief Neurological examination
Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Measured: Assessments up through 28 weeks
Brief Psychiatric assessments
Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Measured: Assessments up through 28 weeks
Columbia-Suicide Severity Rating Scale
The scale is designed to assess suicidal behavior and ideation
Measured: Assessments up through 28 weeks
Cornell Scale for Depression in Dementia
Assesses the signs and symptoms of major depression in patients with dementia
Measured: Assessments up through 28 weeks
Electrocardiogram
Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Measured: Assessments up through 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.
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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 343 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Laura Gault, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01690195
- Sponsor's protocol ID
- M11-428
- Other IDs
- 2012-000537-39
- Status last verified
- Jul 2021
- First submitted
- 19 Sep 2012
- Last updated
- 2 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.
PubMed 26967214
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-Term Safety and Tolerability of ABT-126 in Adults With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: An Open-Label Extension Study for Subjects Completing Study M11-793
- ClinicalTrials.gov ID
- NCT01690195
- Acronym / sponsor ID
- M11-428
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.
- Enrolment
- 343 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Sep 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 21 Sep 2012 (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 long term extension study to evaluate safety and tolerability of subjects who complete study M11-793 which is evaluating a new treatment for subjects with mild to moderate Alzheimer's disease on stable doses of acetylcholinesterase inhibitors.
Detailed description
This is a Phase 2, open-label, multicenter, 28 week extension study to evaluate the long-term safety and tolerability of ABT-126 in subjects who complete dosing through Week 24 of Study M11-793. Up to 420 subjects may participate at approximately 40 sites in seven countries.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ABT-126 | Experimental | Drug: ABT-126ABT-126 Open-label dose |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The subject and caregiver must voluntarily sign and date an informed consent. If the subject does not have the capacity to provide informed consent, full informed consent must be obtained from the subject's representative and assent must be obtained from the subject.
- The subject was randomized into Study M11-793 and completed dosing through Week 24 in that study.
- With the exception of a diagnosis of mild to moderate AD and the presence of stable medical conditions, the subject is in general good health, based upon the results of medical history, physical examination, vital signs, laboratory profile, and a 12-lead ECG.
- If male, the subject is surgically sterile (vasectomy, is sexually inactive, or is using a barrier method of birth control (condom) with spermicidal foam/gel/film/cream/suppository for the duration of the study and for 30 days following the last dose of study drug. However, if the male subject's partner has been postmenopausal for at least two years or is surgically sterile, then use of a barrier method of birth control is not required.
- The subject has an identified, reliable caregiver who will provide support and ensure compliance with the study medication and procedures, and provide accurate information about the subject's status during the study.
Key exclusion criteria (7 listed)
- The subject experienced an adverse event or abnormal finding in physical examination, vital signs, laboratory profile and/or ECG measurements in Study M11-793 that indicates the subject could become medically unstable during the current study.
- The subject is currently taking or is expected to be prescribed any excluded medications without the approval of Abbott medical monitor.
- The subject was noncompliant with donepezil or rivastigmine during Study M11-793 or is expected to discontinue these medications prior to conclusion of this study.
- The subject anticipates a move outside the geographic area of the investigative site or is planning extended travel inconsistent with the recommended visit intervals.
- The subject is currently enrolled in, or plans to participate in, another experimental study during the course of this trial.
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-126See arm description | Drug | ABT-126 |
Primary outcome
Adverse Events
Time frame: Assessments up through 28 weeks
Monitor each subject for clinical and laboratory evidence of adverse events on a routine basis throughout the study
Laboratory Data
Time frame: Assessments up through 28 weeks
Assessments include hematology, clinical chemistry, urinalysis and urine drug/alcohol screens
Vital Signs
Time frame: Assessments up through 28 weeks
Assessments include pulse, blood pressure and oral body temperature
Physical examinations
Time frame: Assessments up through 28 weeks
An examination of bodily functions and physical condition
Brief Neurological examination
Time frame: Assessments up through 28 weeks
Assessments include cranial nerves, motor and sensory system, reflexes, coordination, gait and station
Brief Psychiatric assessments
Time frame: Assessments up through 28 weeks
Assessments include mood, anxiety, psychosis or delusions, agitation, homicidal thoughts or behaviors
Columbia-Suicide Severity Rating Scale
Time frame: Assessments up through 28 weeks
The scale is designed to assess suicidal behavior and ideation
Cornell Scale for Depression in Dementia
Time frame: Assessments up through 28 weeks
Assesses the signs and symptoms of major depression in patients with dementia
Electrocardiogram
Time frame: Assessments up through 28 weeks
Measurements include heart rate, RR interval, PR interval, QRS duration and QT intervals
Results and safety
The study was stopped early (reason given: Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2021.
- Results publication: PubMed 26967214Florian H, Meier A, Gauthier S, Lipschitz S, Lin Y, Tang Q, Othman AA, Robieson WZ, Gault LM. Efficacy and Safety of ABT-126 in Subjects with Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors: A Randomized, Double-Blind, Placebo-Controlled Study. J Alzheimers Dis. 2016;51(4):1237-47. doi: 10.3233/JAD-150978.
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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.
Laura Gault, MD study director
AbbVie
39 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 39 sites in 7 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 6 inclusion and 7 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 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in United States, Germany, Canada, France, Greece and 2 more countries. 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 (reason given: Data obtained from the M11-428 study is not critical to the continued evaluation of ABT-126.). 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?
Adverse Events (time frame: Assessments up through 28 weeks). The study lists 9 primary outcomes in all. 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 NCT01690195, 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 2 Aug 2021.