Alzheimer's DiseasePhase 2NCT01018875
Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
A Phase 2 study testing ABT-288 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 21 sites in 2 countries.
Trial summary
Efficacy and safety study of ABT-288 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-288 and donepezil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 242 participants
- Where
- 21 sitesin 2 countries
- Study dates
- Dec 2009to Feb 2011
- 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
Inclusion Criteria: 1. Have voluntarily signed an informed consent. 2. Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease). 3. Female subjects must be postmenopausal for at least 2 years or surgically sterile. 4. Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control. 5. Subject has an identified, reliable caregiver. 6. Subject has a CT or MRI scan within 36 months prior to randomization. 7. With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, the subject is generally in good health based on medical history, physical examination, vital signs, clinical lab tests and ECG Exclusion Criteria: 1. Subject is currently taking or has taken a medication for the treatment of AD or dementia with 60 days of Screening visit, or is participating in cognitive therapy for the treatment of AD or dementia. 2. Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence. 3. Subject has a history of any significant neurologic disease other than AD. 4. Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation. 5. Subject has received any investigation product within 6 weeks prior to study drug administration.
Trial locations and contacts
21 sites in 2 countries.
21 sites in 2 countries
Ukraine11 sites
Site Reference ID/Investigator# 22630
Dnipro, 49027
Site Reference ID/Investigator# 22625
Donetsk
Site Reference ID/Investigator# 22624
Hlevakha, 08631
Site Reference ID/Investigator# 22629
Kharkiv, 61168
Site Reference ID/Investigator# 24565
Kherson, 73488
Site Reference ID/Investigator# 24566
Kiev, 04112
Site Reference ID/Investigator# 22622
Kiev, 04114
Site Reference ID/Investigator# 22623
Kiev, 05113
Site Reference ID/Investigator# 22628
Luhansk, 91045
Site Reference ID/Investigator# 43143
Odesa, 65006
Site Reference ID/Investigator# 22627
Poltava, 36006
Russia10 sites
Site Reference ID/Investigator# 22687
Kazan', 420012
Site Reference ID/Investigator# 22636
Moscow, 115522
Site Reference ID/Investigator# 23702
Moscow, 123995
Site Reference ID/Investigator# 22635
Saint Petersburg, 190005
Site Reference ID/Investigator# 22633
Saint Petersburg, 190103
Site Reference ID/Investigator# 22637
Saint Petersburg, 190121
Site Reference ID/Investigator# 22632
Saint Petersburg, 192019
Site Reference ID/Investigator# 22634
Saint Petersburg, 192019
Site Reference ID/Investigator# 24563
Saint Petersburg, 194044
Site Reference ID/Investigator# 22689
Saratov, 410060
About this study
Official title: A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-288, donepezil, placebo
- 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-288Drug
Subjects will take 4 capsules once daily for 12 weeks.
donepezilDrug
Also called Aricept
Subjects will take 4 capsules once daily for 12 weeks.
placeboDrug
Subjects will take 4 capsules once daily for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1, Dose 1, ABT-288 | Experimental | Low Dose Receives: Drug: ABT-288 |
| Arm 2, Dose 2, ABT-288 | Experimental | High dose Receives: Drug: ABT-288 |
| donepezil | Active comparator | Not described Receives: Drug: donepezil |
| sugar pill | Placebo comparator | Not described Receives: Drug: placebo |
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: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
Secondary outcomes (4)
MMSE: Mini Mental Status Exam
Measured: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
NPI: Neuropsychiatric Inventory
Measured: Day -1, Weeks 4,8, 12/PD
ADCS-ADL: Alzheimer's Disease Cooperative Study
Measured: Day -1, Weeks 4,8 & 12/PD
CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
Measured: Day -1, Weeks 4,8 & 12/PD]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionFeb 2011
- Study completionFeb 2011
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
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Haig, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01018875
- Sponsor's protocol ID
- M10-822
- Other IDs
- 2009-010704-29, 2009
- Status last verified
- Jan 2013
- First submitted
- 20 Nov 2009
- Last updated
- 6 Jun 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hung SY, Fu WM. Drug candidates in clinical trials for Alzheimer's disease. J Biomed Sci. 2017 Jul 19;24(1):47. doi: 10.1186/s12929-017-0355-7.
PubMed 28720101
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Active- and Placebo-Controlled Study to Evaluate the Efficacy and Safety of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01018875
- Acronym / sponsor ID
- M10-822
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 24 Nov 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.
Efficacy and safety study of ABT-288 in adults with mild-to-moderate 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
- 4
| Arm | Type | Receives |
|---|---|---|
| Arm 1, Dose 1, ABT-288 | Experimental | Drug: ABT-288Low Dose |
| Arm 2, Dose 2, ABT-288 | Experimental | Drug: ABT-288High dose |
| donepezil | Active comparator | Drug: donepezil |
| sugar pill | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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-288Subjects will take 4 capsules once daily for 12 weeks. | Drug | Arm 1, Dose 1, ABT-288, Arm 2, Dose 2, ABT-288 |
| donepezilAlso: AriceptSubjects will take 4 capsules once daily for 12 weeks. | Drug | donepezil |
| placeboSubjects will take 4 capsules once daily for 12 weeks. | Drug | sugar pill |
Primary outcome
ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion
Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
4 secondary outcomes
MMSE: Mini Mental Status Exam
Time frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD
NPI: Neuropsychiatric Inventory
Time frame: Day -1, Weeks 4,8, 12/PD
ADCS-ADL: Alzheimer's Disease Cooperative Study
Time frame: Day -1, Weeks 4,8 & 12/PD
CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus
Time frame: Day -1, Weeks 4,8 & 12/PD]
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 6 Jun 2018.
- Background: PubMed 28720101Hung SY, Fu WM. Drug candidates in clinical trials for Alzheimer's disease. J Biomed Sci. 2017 Jul 19;24(1):47. doi: 10.1186/s12929-017-0355-7.
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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.
George Haig study director
AbbVie
21 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-288 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 21 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in Ukraine, Russia. 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: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD). 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 NCT01018875, 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 6 Jun 2018.