Back to resultsA Safety and Tolerability Study of ABT-126 in Elderly
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-126
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion Criteria:
- Healthy male or female subjects 65 years or greater.
- Has a MMSE score of 27 or higher.
Exclusion Criteria:
- History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
- History of any significant neurological disease.
- Has an estimated creatinine clearance < 30 mL/min
Sites / Locations
- Site Reference ID/Investigator# 17283
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
20mg of ABT-126 QD
30mg and 45mg ABT-126 QD
Arm Description
20 mg of ABT-126 QD for 10 days
30 mg and 45mg of ABT-126 QD for 21 days
Outcomes
Primary Outcome Measures
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Assess the Pharmacokinetics
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00867399
Brief Title
A Safety and Tolerability Study of ABT-126 in Elderly
Official Title
A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
Study Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
March 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Abbott
4. Oversight
5. Study Description
Brief Summary
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
20mg of ABT-126 QD
Arm Type
Active Comparator
Arm Description
20 mg of ABT-126 QD for 10 days
Arm Title
30mg and 45mg ABT-126 QD
Arm Type
Active Comparator
Arm Description
30 mg and 45mg of ABT-126 QD for 21 days
Intervention Type
Drug
Intervention Name(s)
ABT-126
Intervention Description
See arm for details
Primary Outcome Measure Information:
Title
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)
Time Frame
Study Days -1 thru Day 28
Title
Assess the Pharmacokinetics
Time Frame
Study Days -1 thru Day 28
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy male or female subjects 65 years or greater.
Has a MMSE score of 27 or higher.
Exclusion Criteria:
History of dementia including by not limited to Alzheimer's disease, Parkinson's disease and mult-infarct dementia.
History of any significant neurological disease.
Has an estimated creatinine clearance < 30 mL/min
Facility Information:
Facility Name
Site Reference ID/Investigator# 17283
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Safety and Tolerability Study of ABT-126 in Elderly
We'll reach out to this number within 24 hrs