Status:
COMPLETED
Safety, Tolerability, and Pharmacokinetics of ABT-354 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Lead Sponsor:
AbbVie
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-90 years
Phase:
PHASE1
Brief Summary
This study will investigate safety, tolerability and pharmacokinetics of ABT-354 in up to 20 male and female subjects, between 55 to 90 years of age with mild to moderate Alzheimer's disease on stable...
Detailed Description
This is a double-blind, placebo-controlled, randomized, multiple-dose, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are taking stable doses o...
Eligibility Criteria
Inclusion
- Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's Disease
- Has a Mini-Mental State Examination total score of 16 to 26, inclusive, at Screening
- Has a Modified Hachinski Ischemia Scale score of ≤ 4 at Screening
- On a stable dose of - donepezil, galantamine or rivastigmine for at least 30 days prior to study drug administration
- Has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization
Exclusion
- Receipt of any depot drug by injection within 30 days prior to study drug administration
- Receipt of an investigational product within a time period equal to 10 half-lives, if known, or within 6 weeks prior to study drug administration
- History of any significant neurological disease other than Alzheimer's Disease
- History of significant sensitivity or allergy to multiple drugs based on medical records and/or the opinion of the investigator
- Significant current - suicidal ideation within 1 month prior to study drug administration as evidenced by answering "yes" to questions 4 or 5 on the suicidal ideation portion of the Columbia-Suicide Severity Rating Scale completed at Screening or any history of suicide attempts
Key Trial Info
Start Date :
July 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01908010
Start Date
July 1 2013
End Date
November 1 2013
Last Update
December 11 2013
Active Locations (3)
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1
Site Reference ID/Investigator# 106999
Miami, Florida, United States, 33169
2
Site Reference ID/Investigator# 106998
Orlando, Florida, United States, 32806
3
Site Reference ID/Investigator# 107000
Overland Park, Kansas, United States, 66212