Efficacy and Safety Study for 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:
NCT00948909
First received: July 24, 2009
Last updated: January 29, 2013
Last verified: January 2013

July 24, 2009
January 29, 2013
October 2009
November 2010   (final data collection date for primary outcome measure)
ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion [ Time Frame: Measurements up through 12 weeks. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00948909 on ClinicalTrials.gov Archive Site
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. ] [ Designated as safety issue: No ]
MMSE, QoL-AD, CIBIC-plus, NPI, CSDD, and ADCS-ADL. Note: Acronyms are fully defined in the area titled Detailed Description. [ Time Frame: Measurements up through 12 weeks. ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease
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.

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
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • Drug: Placebo
    Placebo intervention
    Other Name: Sugar Pill
  • Drug: ABT-126
    Experimental intervention
  • Drug: donepezil
    Active comparator intervention
    Other Name: Aricept
  • Placebo Comparator: A. Sugar Pill
    Intervention: Drug: Placebo
  • Experimental: B. ABT-126
    Intervention: Drug: ABT-126
  • Experimental: C. ABT-126
    Intervention: Drug: ABT-126
  • Active Comparator: D. donepezil
    Intervention: Drug: donepezil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
274
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
Both
55 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   United Kingdom,   South Africa,   Czech Republic,   Bulgaria,   Slovakia
 
NCT00948909
M10-984, 2009-011424-64
Not Provided
AbbVie ( AbbVie (prior sponsor, Abbott) )
AbbVie (prior sponsor, Abbott)
Not Provided
Study Director: Laura Gault, MD AbbVie
AbbVie
January 2013

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