Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:55 - 90
Updated:5/27/2013
Start Date:February 2012
End Date:November 2013
Contact:Linda Balen, MS
Email:linda.balen@abbvie.com
Phone:847-936-0475

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A Randomized, Double-Blind, Placebo and Active-Controlled Study to Evaluate the Efficacy and Safety of ABT-126 in Subjects With Mild to Moderate Alzheimer's Disease


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


This is a Phase 2 study designed to evaluate the efficacy and safety of ABT-126 in
approximately 410 adults with mild to moderate Alzheimer's disease. Subjects will be
randomized to one of 5 treatment groups (ABT-126, donepezil or placebo) for a 24-week
treatment period.

Inclusion Criteria:

- The subject and caregiver must voluntarily sign and date an informed consent. If the
subject does not have the capacity to provide informed consent, full informed consent
must be obtained from the subject's representative and assent must be obtained from
the subject.

- The subject is a male or female between the ages of 55 and 90 years, inclusive, at
Screening Visit 1.

- The subject meets the National Institute of Neurological and Communicative Disorders
and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA)
criteria for probable Alzheimer's disease.

- The subject has a Mini-Mental Status Examination (MMSE) total score of 10 to 24,
inclusive, at Screening Visit 1.

- The subject has a Cornell Scale for Depression in Dementia (CSDD) score ≤ 10 at
Screening Visit 1.

- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening
Visit 1.

- With the exception of a diagnosis of mild to moderate AD and the presence of stable
medical conditions, the subject is in general good health, based upon the results of
medical history, physical examination, vital signs, laboratory profile, and a 12-lead
electrocardiogram (ECG).

- The subject has an identified, reliable caregiver who will provide support and ensure
compliance with the study medication and procedures, and provide accurate information
about the subject's status during the study.

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, or is
participating in cognitive therapy for the treatment of Alzheimer's disease or
dementia.

- The subject has clinically significant abnormal laboratory values at Screening Visit
1 as determined by the investigator.

- The subject has a history of any significant neurologic disease other than
Alzheimer's disease including Parkinson's disease, multi-infarct or vascular
dementia, Huntington's disease, normal pressure hydrocephalus, progressive
supranuclear palsy, multiple sclerosis, any seizures, mental retardation or a history
of significant head trauma followed by persistent neurologic deficits or known
structural brain abnormalities.

- In the opinion of the investigator, the subject has any clinically significant
uncontrolled medical or psychiatric illness.

- The subject has a known hypersensitivity or intolerance to donepezil that lead to
discontinuation or a known reported history of donepezil treatment failure.
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