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. Identifier: NCT00948909
Recruitment Status : Completed
First Posted : July 29, 2009
Last Update Posted : January 31, 2013
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

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.

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

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 identifier (NCT number): NCT00948909

United States, California
Site Reference ID/Investigator# 19904
Fresno, California, United States, 93720
United States, Florida
Site Reference ID/Investigator# 23025
West Palm Beach, Florida, United States, 33407
United States, Indiana
Site Reference ID/Investigator# 19905
Indianapolis, Indiana, United States, 46260
Site Reference ID/Investigator# 22944
Pleven, Bulgaria, 5800
Site Reference ID/Investigator# 22942
Plovdiv, Bulgaria, 4000
Site Reference ID/Investigator# 22945
Sofia, Bulgaria, 1113
Site Reference ID/Investigator# 22946
Sofia, Bulgaria, 1431
Czech Republic
Site Reference ID/Investigator# 20276
Litomerice, Czech Republic, 412 01
Site Reference ID/Investigator# 20273
Plzen, Czech Republic, 301 36
Site Reference ID/Investigator# 20274
Prague 10, Czech Republic, 100 00
Site Reference ID/Investigator# 20272
Prague 2, Czech Republic, 120 00
Site Reference ID/Investigator# 20701
Prague 5, Czech Republic, 15006
Site Reference ID/Investigator# 23625
Bratislava, Slovakia, 82606
Site Reference ID/Investigator# 23624
Bratislava, Slovakia
Site Reference ID/Investigator# 23622
Michalovce, Slovakia, 07101
Site Reference ID/Investigator# 23942
Rimavska Sobota, Slovakia, 979 12
South Africa
Site Reference ID/Investigator# 20267
Belville, South Africa, 7530
Site Reference ID/Investigator# 20266
Cape Town, South Africa, 7500
Site Reference ID/Investigator# 20261
Durban, South Africa, 4001
Site Reference ID/Investigator# 21682
George, South Africa, 6529
Site Reference ID/Investigator# 20265
Johannesburg, South Africa, 2196
Site Reference ID/Investigator# 20271
Port Elizabeth, South Africa, 6001
Site Reference ID/Investigator# 20263
Richards Bay, South Africa, 3900
United Kingdom
Site Reference ID/Investigator# 20187
Blackburn, United Kingdom, BB2 3HH
Site Reference ID/Investigator# 20183
Bradford, United Kingdom, BD3 0DQ
Site Reference ID/Investigator# 20191
Crowborough, United Kingdom, TN6 1HB
Site Reference ID/Investigator# 20184
Glasgow, United Kingdom, G20 0XA
Site Reference ID/Investigator# 20190
London, United Kingdom, TW8 8DS
Site Reference ID/Investigator# 20192
Southampton, United Kingdom, SO30 3JB
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Study Director: Laura Gault, MD AbbVie

Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT00948909     History of Changes
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:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents