Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease

This study has been completed.
Sponsor:
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

November 20, 2009
January 22, 2013
December 2009
February 2011   (final data collection date for 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01018875 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Efficacy and Safety Study of ABT-288 in Subjects With Mild-to-Moderate Alzheimer's Disease
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: ABT-288
    Subjects will take 4 capsules once daily for 12 weeks.
  • Drug: donepezil
    Subjects will take 4 capsules once daily for 12 weeks.
    Other Name: Aricept
  • Drug: placebo
    Subjects will take 4 capsules once daily for 12 weeks.
  • Experimental: Arm 1, Dose 1, ABT-288
    Low Dose
    Intervention: Drug: ABT-288
  • Experimental: Arm 2, Dose 2, ABT-288
    High dose
    Intervention: Drug: ABT-288
  • Active Comparator: donepezil
    Intervention: Drug: donepezil
  • Placebo Comparator: sugar pill
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
242
February 2011
February 2011   (final data collection date for primary outcome measure)

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.
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Ukraine,   Russian Federation
 
NCT01018875
M10-822, 2009-010704-29
Yes
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: George Haig AbbVie
AbbVie
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP