A Safety and Tolerability Study of ABT-126 in Elderly

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: ABT-126

• Registration Number: NCT00867399
• Lead Sponsor: Abbott

Brief Summary

The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2009-03-19
• Study First Submitted QC: 2009-03-20
• Study First Posted: 2009-03-23
• Primary Completion: 2009-05
• Status Verified: 2010-09
• Last Update Submitted: 2010-10-31
• Last Update Posted: 2010-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
20mg of ABT-126 QD	ABT-126	20 mg of ABT-126 QD for 10 days
30mg and 45mg ABT-126 QD	ABT-126	30 mg and 45mg of ABT-126 QD for 21 days

Primary Outcome Measures

Name	Time	Method
Safety and Tolerability Assessments (i.e., ECG, clinical laboratory tests, vital signs, weight, AE assessment, physical and brief neurological examinations)	Study Days -1 thru Day 28
Assess the Pharmacokinetics	Study Days -1 thru Day 28

Trial Locations

Locations (1)

Site Reference ID/Investigator# 17283; 🇺🇸 Orlando, Florida, United States