Status:
TERMINATED
Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 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 is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.
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 (AD);
- Has a Mini-Mental State Examination total score of 16 to 26;
- Has a Modified Hachinski Ischemia Scale score of ≤ 4;
- Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
- Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
- With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.
Exclusion
- Positive screen for drugs of abuse, alcohol or cotinine;
- Females must not have positive results for pregnancy;
- Focal neurological signs on examination;
- Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
- History of any significant neurologic disease other than AD;
- History of head trauma, motor vehicle accident, concussion.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT02220738
Start Date
September 1 2014
End Date
March 1 2016
Last Update
July 6 2021
Active Locations (4)
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1
Site Reference ID/Investigator# 129545
Glendale, California, United States, 91206
2
Site Reference ID/Investigator# 129435
Orlando, Florida, United States, 32806
3
Site Reference ID/Investigator# 129641
New York, New York, United States, 10019
4
Site Reference ID/Investigator# 144825
Salt Lake City, Utah, United States, 84106