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Efficacy and Safety Study of ABT-288 in 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: NCT01018875
Recruitment Status : Completed
First Posted : November 24, 2009
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):

Study Description
Brief Summary:
Efficacy and safety study of ABT-288 in adults with mild-to-moderate Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABT-288 Drug: donepezil Drug: placebo Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 242 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2009
Primary Completion Date : February 2011
Study Completion Date : February 2011

Arms and Interventions

Arm Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :
  1. ADAS-cog: Alzheimer's Disease Assessment Scale - Cognition portion [ Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD ]

Secondary Outcome Measures :
  1. MMSE: Mini Mental Status Exam [ Time Frame: Screening Visit 1 & 2, Day -1, Weeks 4, 8 & 12/PD ]
  2. NPI: Neuropsychiatric Inventory [ Time Frame: Day -1, Weeks 4,8, 12/PD ]
  3. ADCS-ADL: Alzheimer's Disease Cooperative Study [ Time Frame: Day -1, Weeks 4,8 & 12/PD ]
  4. CIBIC-Plus: Clinician Interview-Baed Impression of Change - plus [ Time Frame: Day -1, Weeks 4,8 & 12/PD] ]

Eligibility Criteria

Information from the National Library of Medicine

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

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

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): NCT01018875

Russian Federation
Site Reference ID/Investigator# 22687
Kazan, Russian Federation, 420012
Site Reference ID/Investigator# 22636
Moscow, Russian Federation, 115522
Site Reference ID/Investigator# 23702
Moscow, Russian Federation, 123995
Site Reference ID/Investigator# 22689
Saratov, Russian Federation, 410060
Site Reference ID/Investigator# 22635
St. Petersburg, Russian Federation, 190005
Site Reference ID/Investigator# 22633
St. Petersburg, Russian Federation, 190103
Site Reference ID/Investigator# 22637
St. Petersburg, Russian Federation, 190121
Site Reference ID/Investigator# 22632
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 22634
St. Petersburg, Russian Federation, 192019
Site Reference ID/Investigator# 24563
St. Petersburg, Russian Federation, 194044
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# 22622
Kiev, Ukraine, 04114
Site Reference ID/Investigator# 22623
Kiev, Ukraine, 05113
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)
Study Director: George Haig AbbVie
More Information

Responsible Party: AbbVie (prior sponsor, Abbott)
ClinicalTrials.gov Identifier: NCT01018875     History of Changes
Other Study ID Numbers: M10-822
2009-010704-29 ( EudraCT Number )
First Posted: November 24, 2009    Key Record Dates
Last Update Posted: January 29, 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