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
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: Placebo
Drug: ABT-126
Drug: donepezil
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • ADAS-Cog - Alzheimer's Disease Assessment Scale Cognition portion [ Time Frame: Measurements up through 12 weeks. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 274
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00948909

Locations
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
Bulgaria
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
Slovakia
Site Reference ID/Investigator# 23624
Bratislava, Slovakia
Site Reference ID/Investigator# 23625
Bratislava, Slovakia, 82606
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)
Investigators
Study Director: Laura Gault, MD AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT00948909     History of Changes
Other Study ID Numbers: M10-984, 2009-011424-64
Study First Received: July 24, 2009
Last Updated: January 29, 2013
Health Authority: United States: Food and Drug Administration

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 July 29, 2014