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
  Purpose

Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Drug: ABT-288
Drug: donepezil
Drug: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

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: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 242
Study Start Date: December 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1, Dose 1, ABT-288
Low Dose
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
Experimental: Arm 2, Dose 2, ABT-288
High dose
Drug: ABT-288
Subjects will take 4 capsules once daily for 12 weeks.
Active Comparator: donepezil Drug: donepezil
Subjects will take 4 capsules once daily for 12 weeks.
Other Name: Aricept
Placebo Comparator: sugar pill Drug: placebo
Subjects will take 4 capsules once daily for 12 weeks.

  Eligibility

Ages Eligible for Study:   55 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01018875

Locations
Russian Federation
Site Reference ID/Investigator# 22687
Kazan, Russian Federation, 420012
Site Reference ID/Investigator# 23702
Moscow, Russian Federation, 123995
Site Reference ID/Investigator# 22636
Moscow, Russian Federation, 115522
Site Reference ID/Investigator# 22689
Saratov, Russian Federation, 410060
Site Reference ID/Investigator# 22634
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 22633
St. Petersburg, Russian Federation, 190103
Site Reference ID/Investigator# 22632
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 22637
St. Petersburg, Russian Federation, 190121
Site Reference ID/Investigator# 24563
St. Petersburg, Russian Federation, 194044
Site Reference ID/Investigator# 22635
St. Petersburg, Russian Federation, 190005
Ukraine
Site Reference ID/Investigator# 22630
Dnipropetrovs'k, Ukraine, 49027
Site Reference ID/Investigator# 22625
Donetsk, Ukraine
Site Reference ID/Investigator# 22624
Glevakha, Ukraine, 08631
Site Reference ID/Investigator# 22629
Kharkiv, Ukraine, 61168
Site Reference ID/Investigator# 24565
Kherson, Ukraine, 73488
Site Reference ID/Investigator# 24566
Kiev, Ukraine, 04112
Site Reference ID/Investigator# 22623
Kiev, Ukraine, 05113
Site Reference ID/Investigator# 22622
Kiev, Ukraine, 04114
Site Reference ID/Investigator# 22628
Lugansk, Ukraine, 91045
Site Reference ID/Investigator# 43143
Odessa, Ukraine, 65006
Site Reference ID/Investigator# 22627
Poltava, Ukraine, 36006
Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
Investigators
Study Director: George Haig AbbVie
  More Information

No publications provided

Responsible Party: AbbVie ( AbbVie (prior sponsor, Abbott) )
ClinicalTrials.gov Identifier: NCT01018875     History of Changes
Other Study ID Numbers: M10-822, 2009-010704-29
Study First Received: November 20, 2009
Last Updated: January 22, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation
Ukraine: State Pharmacological Center - Ministry of Health
Russia: FSI Scientific Center of Expertise of Medical Application

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 April 17, 2014