Alzheimer's DiseasePhase 2NCT00948909
Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease
A Phase 2 study testing ABT-126 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 29 sites in 6 countries.
Trial summary
This is a efficacy and safety study evaluating 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?
- ABT-126 and donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 274 participants
- Where
- 29 sitesin 6 countries
- Study dates
- Oct 2009to Nov 2010
- 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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
- The subject meets the NINCDS/ADRDA criteria for probable AD.
- The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
- If female, subject must be postmenopausal for at least two years or surgically sterile
- The subject has an identified, reliable, caregiver.
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
- The subject has a history of any significant neurologic disease other than AD.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- The subject has reported history of discontinuation of donepezil due to lack of efficacy.
- The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
- The subject has a known hypersensitivity to donepezil, piperidine derivatives, or any of the excipients in either donepezil hydrochloride or ABT-126 formulations.
- Patient uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
- Subjects with AST and ALT values at Screening Visit 1 that are greater than or equal to 1.5-fold the upper limit of normal (ULN).
Trial locations and contacts
29 sites in 6 countries.
29 sites in 6 countries
South Africa7 sites
Site Reference ID/Investigator# 20267
Belville, 7530
Site Reference ID/Investigator# 20266
Cape Town, 7500
Site Reference ID/Investigator# 20261
Durban, 4001
Site Reference ID/Investigator# 21682
George, 6529
Site Reference ID/Investigator# 20265
Johannesburg, 2196
Site Reference ID/Investigator# 20271
Port Elizabeth, 6001
Site Reference ID/Investigator# 20263
Richards Bay, 3900
United Kingdom6 sites
Site Reference ID/Investigator# 20187
Blackburn, BB2 3HH
Site Reference ID/Investigator# 20183
Bradford, BD3 0DQ
Site Reference ID/Investigator# 20191
Crowborough, TN6 1HB
Site Reference ID/Investigator# 20184
Glasgow, G20 0XA
Site Reference ID/Investigator# 20190
London, TW8 8DS
Site Reference ID/Investigator# 20192
Southampton, SO30 3JB
Czechia5 sites
Site Reference ID/Investigator# 20276
Litoměřice, 412 01
Site Reference ID/Investigator# 20273
Pilsen, 301 36
Site Reference ID/Investigator# 20274
Prague, 100 00
Site Reference ID/Investigator# 20272
Prague, 120 00
Site Reference ID/Investigator# 20701
Prague, 15006
Bulgaria4 sites
Site Reference ID/Investigator# 22944
Pleven, 5800
Site Reference ID/Investigator# 22942
Plovdiv, 4000
Site Reference ID/Investigator# 22945
Sofia, 1113
Site Reference ID/Investigator# 22946
Sofia, 1431
Slovakia4 sites
Site Reference ID/Investigator# 23625
Bratislava, 82606
Site Reference ID/Investigator# 23624
Bratislava
Site Reference ID/Investigator# 23622
Michalovce, 07101
Site Reference ID/Investigator# 23942
Rimavská Sobota, 979 12
United States3 sites
Site Reference ID/Investigator# 19904
Fresno, California, 93720
Site Reference ID/Investigator# 19905
Indianapolis, Indiana, 46260
Site Reference ID/Investigator# 23025
West Palm Beach, Florida, 33407
About this study
Official title: A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease
This is a efficacy and safety study evaluating 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 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:
- MMSE - Mini Mental Status Exam
- QoL-AD - Quality of Life - Alzheimer's Disease
- CIBIC-plus - Clinician Interview-Based Impression of Change
- NPI - Neuropsychiatric Inventory
- CSDD - The Cornell Scale for depression in Dementia
- ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living
- Conditions
- Alzheimer's Disease
- Being tested
- Placebo, ABT-126, donepezil
- 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
Also called Sugar Pill
Placebo intervention
ABT-126Drug
Experimental intervention
donepezilDrug
Also called Aricept
Active comparator intervention
| Study group | Role | What they receive |
|---|---|---|
| A. Sugar Pill | Placebo comparator | Not described Receives: Drug: Placebo |
| B. ABT-126 | Experimental | Not described Receives: Drug: ABT-126 |
| C. ABT-126 | Experimental | Not described Receives: Drug: ABT-126 |
| D. donepezil | Active comparator | Not described Receives: Drug: donepezil |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Measured: Measurements up through 12 weeks.
Secondary outcomes (1)
MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.
Measured: Measurements up through 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2009 (estimated)
- Study startOct 2009
- Primary completionNov 2010
- Study completionNov 2010
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
- 274 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
- NCT00948909
- Sponsor's protocol ID
- M10-984
- Other IDs
- 2009-011424-64, 2009
- Status last verified
- Jan 2013
- First submitted
- 24 Jul 2009
- Last updated
- 31 Jan 2013
- Results posted
- No
Publications
Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, Othman AA, Lenz RA. A phase 2 randomized, controlled trial of the alpha7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia. Alzheimers Dement (N Y). 2015 Jun 23;1(1):81-90. doi: 10.1016/j.trci.2015.06.001. eCollection 2015 Jun.
PubMed 29854928
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT00948909
- Acronym / sponsor ID
- M10-984
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 274 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Oct 2009
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 29 Jul 2009 (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 efficacy and safety study evaluating 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 260 adults with mild-to-moderate Alzheimer's disease (AD). Subjects will be randomized to one of the four treatment groups (ABT-126, donepezil, or placebo) for a 12-week Treatment Period. Acronyms are listed in the secondary outcome section, below, you will find a list of the acronyms defined:
- MMSE - Mini Mental Status Exam
- QoL-AD - Quality of Life - Alzheimer's Disease
- CIBIC-plus - Clinician Interview-Based Impression of Change
- NPI - Neuropsychiatric Inventory
- CSDD - The Cornell Scale for depression in Dementia
- ADCS-ADL - Alzheimer's Disease Cooperative Study - Activities of Daily Living
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A. Sugar Pill | Placebo comparator | Drug: Placebo |
| B. ABT-126 | Experimental | Drug: ABT-126 |
| C. ABT-126 | Experimental | Drug: ABT-126 |
| D. donepezil | Active comparator | Drug: donepezil |
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 is a male or female between the ages of 55 and 90 years, inclusive, at Screening Visit 1.
- The subject meets the NINCDS/ADRDA criteria for probable AD.
- The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24, inclusive, at Screening Visit 1.
- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of less than or equal to 4 at Screening Visit 1.
- If female, subject must be postmenopausal for at least two years or surgically sterile
Key exclusion criteria (8 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
- The subject has a history of any significant neurologic disease other than AD.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness.
- The subject has reported history of discontinuation of donepezil due to lack of efficacy.
- The subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
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 |
|---|---|---|
| PlaceboAlso: Sugar PillPlacebo intervention | Drug | A. Sugar Pill |
| ABT-126Experimental intervention | Drug | B. ABT-126, C. ABT-126 |
| donepezilAlso: AriceptActive comparator intervention | Drug | D. donepezil |
Primary outcome
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion
Time frame: Measurements up through 12 weeks.
1 secondary outcome
MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, ADAS-Cog (13 item) and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description.
Time frame: Measurements up through 12 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 31 Jan 2013.
- Derived from this study: PubMed 29854928Gault LM, Ritchie CW, Robieson WZ, Pritchett Y, Othman AA, Lenz RA. A phase 2 randomized, controlled trial of the alpha7 agonist ABT-126 in mild-to-moderate Alzheimer's dementia. Alzheimers Dement (N Y). 2015 Jun 23;1(1):81-90. doi: 10.1016/j.trci.2015.06.001. eCollection 2015 Jun.
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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
29 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 ABT-126 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 29 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 6 inclusion and 8 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 31 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in South Africa, United Kingdom, Czechia, Bulgaria, Slovakia 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?
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion (time frame: Measurements up through 12 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 NCT00948909, 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 31 Jan 2013.