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Efficacy and Safety Study of ABT-384 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. Identifier: NCT01137526
Recruitment Status : Completed
First Posted : June 4, 2010
Last Update Posted : January 29, 2013
Information provided by (Responsible Party):
AbbVie ( AbbVie (prior sponsor, Abbott) )

Brief Summary:
The purpose of this study is to test if the investigational medication, ABT-384, is a safe and effective treatment for adults with mild-to-moderate Alzheimer's Disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABT-384 Drug: donepezil Drug: placebo Phase 2

Detailed Description:
This is a Phase 2 study designed to evaluate the safety and efficacy of ABT-384 in approximately 260 adults with mild-to-moderate Alzheimer's Disease (AD). Subjects will be randomized to one of four treatment groups (ABT-384, donepezil, or placebo) for a 12-week Treatment Period.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 267 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-384 in Subjects With Mild-to-Moderate Alzheimer's Disease
Study Start Date : May 2010
Actual Primary Completion Date : July 2011
Actual Study Completion Date : July 2011

Arm Intervention/treatment
Experimental: ABT-384 Dose 1 Drug: ABT-384
Subjects will take study drug once daily for 12 weeks

Experimental: ABT-384 Dose 2 Drug: ABT-384
Subjects will take study drug once daily for 12 weeks

Active Comparator: donepezil Drug: donepezil
Subjects will take study drug once daily for 12 weeks.
Other Name: Aricept

Placebo Comparator: placebo Drug: placebo
Subjects will take study drug once daily for 12 weeks

Primary Outcome Measures :
  1. Change from baseline to final observation in the Alzheimer's Disease Assessment Scale-Cognition portion (ADAS-cog) total score [ Time Frame: 12 Weeks ]

Secondary Outcome Measures :
  1. Mini Mental Status Examination (MMSE) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ]
  2. Clinician's Interview Based Impression of Change-plus (CIBIC-plus) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ]
  3. Neuropsychiatric Inventory (NPI) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 12 Weeks ]
  4. Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) score at Baseline, Weeks 4, 8, and 12 [ Time Frame: 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

Inclusion Criteria:

  1. The subject and caregiver must voluntarily sign and date and informed consent. If the subject is not fully competent, full informed consent must be obtained from a legal representative and assent must be obtained from the subject.
  2. Subject is male or female between the ages of 55 and 90 years of age, inclusive, at Day-1.
  3. Subject meets the NINCDS/ADRDA criteria for probable AD.
  4. Subject has a Mini-Mental Status Examination (MMSE) score of 10 to 24, inclusive, at Screening Visit 1.
  5. Subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at Screening Visit 1.
  6. 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 12-lead ECG.
  7. If female, subject must be postmenopausal for at least 2 years or surgically sterile.
  8. If male, the subject is surgically sterile (vasectomy), is sexually inactive, or is using a barrier method of birth control.
  9. Subject has an identified reliable, caregiver (e.g., family member, social worker, nurse), who will provide support and ensure compliance with the study medication and procedures.
  10. Subject and caregiver are fluent in the language used for administration of the rating scales or cognitive tests and have sufficient visual, hearing and graphomotor skills to complete procedures.

Exclusion Criteria:

  1. Subject has a known hypersensitivity or intolerance to donepezil that led to discontinuation or a known reported history of donepezil treatment failure.
  2. Subject is currently taking or has taken a medication for the treatment of AD or dementia within 60 days of Screening Visit 1, or is participating in cognitive therapy for the treatment of AD or dementia.
  3. Subject has a history of a drug or alcohol disorder (abuse/dependence), based on either DSM-IV-TR or ICD-10 criteria, excluding nicotine, within 2 years prior to Screening Visit 1.
  4. In the opinion of the investigator, the subject has any clinically significant uncontrolled medical or psychiatric illness that would affect the safety of the subject.
  5. The subject has a current thyroid disease or history of thyroid disease, and is not currently being treated with a stable dose of thyroid replacement medication.
  6. For any reason the investigator considers the subject to be an unsuitable candidate to receive ABT-384 or donepezil.

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): NCT01137526

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Sponsors and Collaborators
AbbVie (prior sponsor, Abbott)
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Study Director: Gerard Marek, MD AbbVie
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: AbbVie (prior sponsor, Abbott) Identifier: NCT01137526    
Other Study ID Numbers: M12-033
2009 017801-12 ( EudraCT Number )
First Posted: June 4, 2010    Key Record Dates
Last Update Posted: January 29, 2013
Last Verified: January 2013
Additional relevant MeSH terms:
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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