Alzheimer's DiseasePhase 2NCT01137526
Efficacy and Safety Study of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
A Phase 2 study testing ABT-384 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 30 sites in 4 countries.
Trial summary
The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for 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-384 and donepezil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 267 participants
- Where
- 30 sitesin 4 countries
- Study dates
- May 2010to Jul 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
Who may be able to join
- The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- Subject meets the NINCDS/ADRDA criteria for probable AD.
- Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 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 generally in good health based on medical history, physical examination, vital signs, clinical lab tests and 12-lead ECG.
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- If female, subject must be postmenopausal for at least 2 years or surgically sterile.
- If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
- Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
- Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.
Who cannot join
- Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
- Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
- For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.
Trial locations and contacts
30 sites in 4 countries.
30 sites in 4 countries
Russia9 sites
Site Reference ID/Investigator# 36304
Kazan', 420097
Site Reference ID/Investigator# 36306
Kirov, 610014
Site Reference ID/Investigator# 37944
Moscow, 119048
Site Reference ID/Investigator# 26904
Saint Petersburg, 190005
Site Reference ID/Investigator# 26902
Saint Petersburg, 190103
Site Reference ID/Investigator# 36305
Saint Petersburg, 198510
Site Reference ID/Investigator# 26909
Saratov, 410060
Site Reference ID/Investigator# 38383
Yaroslavl, 150030
Site Reference ID/Investigator# 40834
Yekaterinburg, 620030
Ukraine9 sites
Site Reference ID/Investigator# 39855
Donetsk, 83003
Site Reference ID/Investigator# 26914
Kharkiv, 61177
Site Reference ID/Investigator# 26912
Kiev, 04114
Site Reference ID/Investigator# 40484
Lviv, 79010
Site Reference ID/Investigator# 27002
Poltava, 36006
Site Reference ID/Investigator# 39856
Poltava, 36024
Site Reference ID/Investigator# 40482
Simferopil, 95006
Site Reference ID/Investigator# 40483
Ternopil, 46020
Site Reference ID/Investigator# 35660
Vinnytsia, 21005
United Kingdom9 sites
Site Reference ID/Investigator# 36327
Bath, BA1 3NG
Site Reference ID/Investigator# 35657
Blackburn, BB2 3HH
Site Reference ID/Investigator# 36330
Crowborough, TN6 1HB
Site Reference ID/Investigator# 36326
Glasgow, G20 0XA
Site Reference ID/Investigator# 44123
Ivybridge, Devon, PL21 9AB
Site Reference ID/Investigator# 35658
London, TW8 8DS
Site Reference ID/Investigator# 35902
Northampton, NN5 6UD
Site Reference ID/Investigator# 36328
Oxford, OX3 9DU
Site Reference ID/Investigator# 36329
Peterborough, PE2 7JU
South Africa3 sites
Site Reference ID/Investigator# 45584
Belville, 7530
Site Reference ID/Investigator# 47102
George, 6529
Site Reference ID/Investigator# 45583
Johannesburg, 2196
About this study
Official title: A Randomized, Double-Blind, Placebo and Active-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of ABT-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.
Read the detailed description
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.
- Conditions
- Alzheimer's Disease
- Being tested
- ABT-384, 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-384Drug
Subjects will take study drug once daily for 12 weeks
donepezilDrug
Also called Aricept
Subjects will take study drug once daily for 12 weeks.
placeboDrug
Subjects will take study drug once daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| ABT-384 Dose 1 | Experimental | Not described Receives: Drug: ABT-384 |
| ABT-384 Dose 2 | Experimental | Not described Receives: Drug: ABT-384 |
| donepezil | Active comparator | Not described Receives: Drug: donepezil |
| placebo | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
Measured: 12 Weeks
Secondary outcomes (4)
Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12
Measured: 12 Weeks
Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12
Measured: 12 Weeks
Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12
Measured: 12 Weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2011
- Study completionJul 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie (prior sponsor, Abbott)
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gerard Marek, MD, Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137526
- Sponsor's protocol ID
- M12-033
- Other IDs
- 2009 017801-12, 2009
- Status last verified
- Jan 2013
- First submitted
- 7 May 2010
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Marek GJ, Katz DA, Meier A, Greco N 4th, Zhang W, Liu W, Lenz RA. Efficacy and safety evaluation of HSD-1 inhibitor ABT-384 in Alzheimer's disease. Alzheimers Dement. 2014 Oct;10(5 Suppl):S364-73. doi: 10.1016/j.jalz.2013.09.010. Epub 2014 Jan 10.
PubMed 24418055
Study at a glance
From the registry record, last updated by the sponsor on 29 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-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT01137526
- Acronym / sponsor ID
- M12-033
- Conditions
- Alzheimer's Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- AbbVie (prior sponsor, Abbott)Industry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 4 Jun 2010 (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-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.
Detailed description
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.
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 |
|---|---|---|
| ABT-384 Dose 1 | Experimental | Drug: ABT-384 |
| ABT-384 Dose 2 | Experimental | Drug: ABT-384 |
| donepezil | Active comparator | Drug: donepezil |
| placebo | 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 (10 listed)
- The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
- Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
- Subject meets the NINCDS/ADRDA criteria for probable AD.
- Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
- Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
Key exclusion criteria (6 listed)
- Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
- Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
- Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
- In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
- The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
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-384Subjects will take study drug once daily for 12 weeks | Drug | ABT-384 Dose 1, ABT-384 Dose 2 |
| donepezilAlso: AriceptSubjects will take study drug once daily for 12 weeks. | Drug | donepezil |
| placeboSubjects will take study drug once daily for 12 weeks | Drug | placebo |
Primary outcome
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score
Time frame: 12 Weeks
4 secondary outcomes
Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12
Time frame: 12 Weeks
Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12
Time frame: 12 Weeks
Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12
Time frame: 12 Weeks
Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12
Time frame: 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 29 Jan 2013.
- Derived from this study: PubMed 24418055Marek GJ, Katz DA, Meier A, Greco N 4th, Zhang W, Liu W, Lenz RA. Efficacy and safety evaluation of HSD-1 inhibitor ABT-384 in Alzheimer's disease. Alzheimers Dement. 2014 Oct;10(5 Suppl):S364-73. doi: 10.1016/j.jalz.2013.09.010. Epub 2014 Jan 10.
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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.
Gerard Marek, MD study director
AbbVie
30 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ABT-384 and donepezil in people with Alzheimer's Disease, run by AbbVie (prior sponsor, Abbott) at 30 sites in 4 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 10 inclusion and 6 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 29 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 30 sites in Russia, Ukraine, United Kingdom, South Africa. 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?
Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score (time frame: 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 NCT01137526, 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 29 Jan 2013.