Status:
COMPLETED
A Phase 1 Study of the Safety, Tolerability and Pharmacokinetics of ABT-126 in Subjects With Alzheimer's Disease
Lead Sponsor:
Abbott
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55-90 years
Phase:
PHASE1
Brief Summary
This study will investigate safety, tolerability and pharmacokinetics of ABT-126 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, parallel group, multicenter study. Up to 20 male and female subjects with mild to moderate Alzheimer's disease (AD) who are takin...
Eligibility Criteria
Inclusion
- Inclusion Criteria
- Male or female and age between 55 and 90 years, inclusive.
- 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 (AD).
- The subject has a Mini-Mental State Examination (MMSE) total score of 16 to 26, inclusive, at Screening Visit.
- The subject has a Modified Hachinski Ischemic Scale (MHIS) score of ≤ 4 at Screening Visit.
- The subject must be on a stable dose of donepezil or rivastigmine for at least 1 month prior to study drug administration.
- The subject has had a computerized tomography or magnetic resonance imaging scan, interpreted by a radiologist or neurologist, within 36 months prior to randomization and after the subject met NINCDS/ADRDA diagnostic criteria for probable AD. The scan must not show evidence for an alternative etiology for dementia.
- Exclusion Criteria
- Receipt of an investigational product within 6 weeks prior to study drug administration.
- History of significant sensitivity or allergy to any drug.
- History of any significant neurological disease other than AD.
- 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 (C-SSRS) completed at Screening or any history of suicide attempts.
Exclusion
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01482845
Start Date
November 1 2011
End Date
March 1 2012
Last Update
May 2 2012
Active Locations (3)
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1
Site Reference ID/Investigator# 62908
Glendale, California, United States, 91206
2
Site Reference ID/Investigator# 62904
Hallandale, Florida, United States, 33009
3
Site Reference ID/Investigator# 62903
Orlando, Florida, United States, 32806