Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
This study has been completed.
Sponsor:
AbbVie (prior sponsor, Abbott)
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier:
NCT01018875
First received: November 20, 2009
Last updated: January 22, 2013
Last verified: January 2013
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Purpose
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: ABT-288 Drug: donepezil Drug: placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
Further study details as provided by AbbVie:
Primary Outcome Measures:
- ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion [ Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- MMSE: Mini Mental Status Exam [ Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD ] [ Designated as safety issue: No ]
- NPI: Neuropsychiatric Inventory [ Time Frame: Day -1, Weeks 4,8, 12/PD ] [ Designated as safety issue: No ]
- ADCS-ADL: Alzheimer's Disease Cooperative Study [ Time Frame: Day -1, Weeks 4,8 & 12/PD ] [ Designated as safety issue: No ]
- CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus [ Time Frame: Day -1, Weeks 4,8 & 12/PD] ] [ Designated as safety issue: No ]
| Enrollment: | 242 |
| Study Start Date: | December 2009 |
| Study Completion Date: | February 2011 |
| Primary Completion Date: | February 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Arm 1, Dose 1, ABT-288
Low Dose
|
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
|
|
Experimental: Arm 2, Dose 2, ABT-288
High dose
|
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
|
| Active Comparator: donepezil |
Drug: donepezil
Subjects will take 4 capsules once daily for 12 weeks.
Other Name: Aricept
|
| Placebo Comparator: sugar pill |
Drug: placebo
Subjects will take 4 capsules once daily for 12 weeks.
|
Eligibility| Ages Eligible for Study: | 55 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Have voluntarily signed an informed consent.
- Subject meets diagnostic criteria criteria for probable AD (Alzheimer's Disease).
- Female subjects must be postmenopausal for at least 2 years or surgically sterile.
- Male subjects must be surgically sterile, sexually inactive or using a barrier method of birth control.
- Subject has an identified, reliable caregiver.
- Subject has a CT or MRI scan within 36 months prior to randomization.
- 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:
- 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.
- Subject uses non-prescribed drugs of abuse or has a history of drug or alcohol abuse/dependence.
- Subject has a history of any significant neurologic disease other than AD.
- Subject has a history of intolerance or adverse reaction to donepezil that led to discontinuation.
- Subject has received any investigation product within 6 weeks prior to study drug administration.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018875
Locations
| Russian Federation | |
| Site Reference ID/Investigator# 22687 | |
| Kazan, Russian Federation, 420012 | |
| Site Reference ID/Investigator# 23702 | |
| Moscow, Russian Federation, 123995 | |
| Site Reference ID/Investigator# 22636 | |
| Moscow, Russian Federation, 115522 | |
| Site Reference ID/Investigator# 22689 | |
| Saratov, Russian Federation, 410060 | |
| Site Reference ID/Investigator# 22634 | |
| St. Petersburg, Russian Federation, 192019 | |
| Site Reference ID/Investigator# 22633 | |
| St. Petersburg, Russian Federation, 190103 | |
| Site Reference ID/Investigator# 22632 | |
| St. Petersburg, Russian Federation, 192019 | |
| Site Reference ID/Investigator# 22637 | |
| St. Petersburg, Russian Federation, 190121 | |
| Site Reference ID/Investigator# 24563 | |
| St. Petersburg, Russian Federation, 194044 | |
| Site Reference ID/Investigator# 22635 | |
| St. Petersburg, Russian Federation, 190005 | |
| Ukraine | |
| Site Reference ID/Investigator# 22630 | |
| Dnipropetrovs'k, Ukraine, 49027 | |
| Site Reference ID/Investigator# 22625 | |
| Donetsk, Ukraine | |
| Site Reference ID/Investigator# 22624 | |
| Glevakha, Ukraine, 08631 | |
| Site Reference ID/Investigator# 22629 | |
| Kharkiv, Ukraine, 61168 | |
| Site Reference ID/Investigator# 24565 | |
| Kherson, Ukraine, 73488 | |
| Site Reference ID/Investigator# 24566 | |
| Kiev, Ukraine, 04112 | |
| Site Reference ID/Investigator# 22623 | |
| Kiev, Ukraine, 05113 | |
| Site Reference ID/Investigator# 22622 | |
| Kiev, Ukraine, 04114 | |
| Site Reference ID/Investigator# 22628 | |
| Lugansk, Ukraine, 91045 | |
| Site Reference ID/Investigator# 43143 | |
| Odessa, Ukraine, 65006 | |
| Site Reference ID/Investigator# 22627 | |
| Poltava, Ukraine, 36006 | |
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
| Study Director: | George Haig | AbbVie |
More Information
No publications provided
| Responsible Party: | AbbVie ( AbbVie (prior sponsor, Abbott) ) |
| ClinicalTrials.gov Identifier: | NCT01018875 History of Changes |
| Other Study ID Numbers: | M10-822, 2009-010704-29 |
| Study First Received: | November 20, 2009 |
| Last Updated: | January 22, 2013 |
| Health Authority: | Russia: Ministry of Health of the Russian Federation Ukraine: State Pharmacological Center - Ministry of Health Russia: FSI Scientific Center of Expertise of Medical Application |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Donepezil |
Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 23, 2013