Alzheimer's DiseasePhase 2NCT01527916
Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
A Phase 2 study testing donepezil and ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 33 sites in 6 countries.
Trial summary
This is an efficacy and safety study evaluating a new treatment for subjects 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?
- donepezil and ABT-126
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 438 participants
- Where
- 33 sitesin 6 countries
- Study dates
- Feb 2012to Nov 2013
- 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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
- The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
- The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
- The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit 1.
- 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 electrocardiogram (ECG).
- 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.
Who cannot join
- The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
- The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
- The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
Trial locations and contacts
33 sites in 6 countries.
33 sites in 6 countries
Russia11 sites
Site Reference ID/Investigator# 60945
Kazan', 420012
Site Reference ID/Investigator# 60955
Kazan', 420097
Site Reference ID/Investigator# 60954
Kirov, 610014
Site Reference ID/Investigator# 60951
Moscow, 119048
Site Reference ID/Investigator# 60959
Moscow, 123995
Site Reference ID/Investigator# 60946
Novosibirsk, 630064
Site Reference ID/Investigator# 60947
Saint Petersburg, 190020
Site Reference ID/Investigator# 60958
Saint Petersburg, 190103
Site Reference ID/Investigator# 60949
Saint Petersburg, 192019
Site Reference ID/Investigator# 60952
Saint Petersburg, 198510
Site Reference ID/Investigator# 60950
Saratov, 410060
United States8 sites
Site Reference ID/Investigator# 56504
Bennington, Vermont, 05201
Site Reference ID/Investigator# 56503
Delray Beach, Florida, 33445
Site Reference ID/Investigator# 62611
Elk Grove Village, Illinois, 60007
Site Reference ID/Investigator# 82994
Jenkintown, Pennsylvania, 19046
Site Reference ID/Investigator# 56506
Staten Island, New York, 10312
Site Reference ID/Investigator# 56518
Tampa, Florida, 33613
Site Reference ID/Investigator# 56514
West Palm Beach, Florida, 33407
Site Reference ID/Investigator# 77636
Wichita Falls, Texas, 76309
South Africa4 sites
Site Reference ID/Investigator# 60911
Belville, 7530
Site Reference ID/Investigator# 76073
Cape Town, 7925
Site Reference ID/Investigator# 60912
George, 6529
Site Reference ID/Investigator# 60910
Johannesburg, 2196
United Kingdom4 sites
Site Reference ID/Investigator# 60960
Bath, BA1 3NG
Site Reference ID/Investigator# 60963
Blackburn, BB2 3HH
Site Reference ID/Investigator# 60962
Glasgow, G20 0XA
Site Reference ID/Investigator# 60961
London, TW8 8DS
Poland3 sites
Site Reference ID/Investigator# 62565
Gdynia, 81-361
Site Reference ID/Investigator# 62563
Poznan, 61-853
Site Reference ID/Investigator# 62562
Szczecin, 71-215
Ukraine3 sites
Site Reference ID/Investigator# 60909
Donetsk, 83037
Site Reference ID/Investigator# 60906
Kiev, 04112
Site Reference ID/Investigator# 60905
Poltava, 36006
About this study
Official title: A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
This is an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.
Read the detailed description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.
- Conditions
- Alzheimer's Disease
- Being tested
- placebo, donepezil, 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.
placeboDrug
Placebo Comparator
donepezilDrug
Active Comparator
ABT-126Drug
low dose, middle dose, high dose
| Study group | Role | What they receive |
|---|---|---|
| sugar pill | Placebo comparator | Not described Receives: Drug: placebo |
| donepezil | Active comparator | Not described Receives: Drug: donepezil |
| ABT-126 Low Dose | Experimental | low dose Receives: Drug: ABT-126 |
| ABT-126 Middle Dose | Experimental | middle dose Receives: Drug: ABT-126 |
| ABT-126 high dose | Experimental | high dose Receives: Drug: ABT-126 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alzheimer's Disease Assessment Scale - cognitive subscale
Measured: Measurements up through 24 weeks
Secondary outcomes (9)
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Caregiver-based assessment of activities of daily living
Measured: Measurements up through 24 weeks
Mini Mental Status Exam (MMSE)
Questionnaire which provides a quantitative measure of cognition
Measured: Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)
Health-related quality of life measurement tool
Measured: Measurements up through 24 weeks
Clinician Interview-Based Impression of Change - plus (CIBIC-plus)
Measures a global impression of change in severity of dementia
Measured: Measurements up through 24 weeks
Neuropsychiatry Inventory (NPI)
Assesses the presence of psychopathology in subjects with Alzheimer's disease and other dementias
Measured: Measurements up through 24 weeks
Partner-Patient Questionnaire for Shared Activities (PPQSA)
Measures the extent to which mood and mental state interferes with the patient-partner relationship
Measured: Measurements up through 24 weeks
Resource Use in Dementia (RUD-Lite)
Brief measurement tool for resource utilization
Measured: Measurements up through 24 weeks
EuroQol-5D Questionnaires
Assesses patient's mobility, self-care, usual activity, pain/discomfort and anxiety/depression
Measured: Measurements up through 24 weeks
Wechsler Memory Scale-III (WMS-III) Working Memory Index
Assesses working memory
Measured: Measurements up through 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionNov 2013
- Study completionNov 2013
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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 438 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
- NCT01527916
- Sponsor's protocol ID
- M10-985
- Other IDs
- 2011-002004-32
- Status last verified
- Nov 2014
- First submitted
- 3 Feb 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.
PubMed 27756421
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01527916
- Acronym / sponsor ID
- M10-985
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 438 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 7 Feb 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 an efficacy and safety study evaluating a new treatment for subjects with mild to moderate Alzheimer's disease.
Detailed description
This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| sugar pill | Placebo comparator | Drug: placebo |
| donepezil | Active comparator | Drug: donepezil |
| ABT-126 Low Dose | Experimental | Drug: ABT-126low dose |
| ABT-126 Middle Dose | Experimental | Drug: ABT-126middle dose |
| ABT-126 high dose | Experimental | Drug: ABT-126high dose |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
- The subject meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's disease.
- The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
- The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
Key exclusion criteria (5 listed)
- The subject is currently taking or has taken a medication for the treatment of Alzheimer's disease or dementia within 60 days prior to Screening Visit 1, or is participating in cognitive therapy for the treatment of Alzheimer's disease or dementia.
- The subject has clinically significant abnormal laboratory values at Screening Visit 1 as determined by the investigator.
- The subject has a history of any significant neurologic disease other than Alzheimer's disease including Parkinson's disease, multi-infarct or vascular dementia, Huntington's disease, normal pressure hydrocephalus, progressive supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- The subject has a known hypersensitivity or intolerance to donepezil that lead to discontinuation or a known reported history of donepezil treatment failure.
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 |
|---|---|---|
| placeboPlacebo Comparator | Drug | sugar pill |
| donepezilActive Comparator | Drug | donepezil |
| ABT-126low dose, middle dose, high dose | Drug | ABT-126 Low Dose, ABT-126 Middle Dose, ABT-126 high dose |
Primary outcome
Alzheimer's Disease Assessment Scale - cognitive subscale
Time frame: Measurements up through 24 weeks
9 secondary outcomes
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Time frame: Measurements up through 24 weeks
Mini Mental Status Exam (MMSE)
Time frame: Measurements up through 24 weeks
DEMentia Quality of Life (DEMQOL)
Time frame: Measurements up through 24 weeks
Clinician Interview-Based Impression of Change - plus (CIBIC-plus)
Time frame: Measurements up through 24 weeks
Neuropsychiatry Inventory (NPI)
Time frame: Measurements up through 24 weeks
Partner-Patient Questionnaire for Shared Activities (PPQSA)
Time frame: Measurements up through 24 weeks
Resource Use in Dementia (RUD-Lite)
Time frame: Measurements up through 24 weeks
EuroQol-5D Questionnaires
Time frame: Measurements up through 24 weeks
Wechsler Memory Scale-III (WMS-III) Working Memory Index
Time frame: Measurements up through 24 weeks
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 19 Nov 2014.
- Derived from this study: PubMed 27756421Gault LM, Lenz RA, Ritchie CW, Meier A, Othman AA, Tang Q, Berry S, Pritchett Y, Robieson WZ. ABT-126 monotherapy in mild-to-moderate Alzheimer's dementia: randomized double-blind, placebo and active controlled adaptive trial and open-label extension. Alzheimers Res Ther. 2016 Oct 18;8(1):44. doi: 10.1186/s13195-016-0210-1.
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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
33 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing donepezil and ABT-126 in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 33 sites in 6 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 8 inclusion and 5 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 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in Russia, United States, South Africa, United Kingdom, Poland and 1 more country. 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 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.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale - cognitive subscale (time frame: Measurements up through 24 weeks). 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 NCT01527916, 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 19 Nov 2014.