A Safety and Tolerability Study of ABT-126 in Elderly

Alzheimer's Disease Clinical Trial

Official title:

A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00867399
• Other study ID #: M10-717
• Status: Completed
• Phase: Phase 1
• First received: March 19, 2009
• Last updated: October 31, 2010
• Start date: March 2009

Study information

• Verified date: September 2010
• Source: Abbott
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. primary completion date: May 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-126
See arm for details

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 17283	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Abbott

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	Assess the Pharmacokinetics		Study Days -1 thru Day 28	No