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Efficacy and Safety Study for Subjects With Mild-to-Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00948909
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : January 31, 2013
Sponsor:
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
This is a efficacy and safety study evaluating new treatment for subjects with mild to moderate Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Placebo Drug: ABT-126 Drug: donepezil Phase 2

Detailed Description:

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : October 2009
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010


Arm Intervention/treatment
Placebo Comparator: A. Sugar Pill Drug: Placebo
Placebo intervention
Other Name: Sugar Pill

Experimental: B. ABT-126 Drug: ABT-126
Experimental intervention

Experimental: C. ABT-126 Drug: ABT-126
Experimental intervention

Active Comparator: D. donepezil Drug: donepezil
Active comparator intervention
Other Name: Aricept




Primary Outcome Measures :
  1. ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion [ Time Frame: Measurements up through 12 weeks. ]

Secondary Outcome Measures :
  1. 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. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00948909


Locations
Show Show 29 study locations
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
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Study Director: Laura Gault, MD AbbVie
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT00948909    
Other Study ID Numbers: M10-984
2009-011424-64 ( EudraCT Number )
First Posted: July 29, 2009    Key Record Dates
Last Update Posted: January 31, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents