A Safety and Tolerability Study of ABT-126 in Elderly

This study has been completed.

Sponsor:

Information provided by:

Abbott

ClinicalTrials.gov Identifier:

NCT00867399

First received: March 19, 2009

Last updated: October 31, 2010

Last verified: September 2010

History of Changes

Tracking Information
First Received Date ^ICMJE	March 19, 2009
Last Updated Date	October 31, 2010
Start Date ^ICMJE	March 2009
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 17, 2009)	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 ] [ Designated as safety issue: Yes ] Assess the Pharmacokinetics [ Time Frame: Study Days -1 thru Day 28 ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE (submitted: March 20, 2009)	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 17 ] [ Designated as safety issue: Yes ] Assess the Pharmacokinetics [ Time Frame: Study Days -1 thru Day 17 ] [ Designated as safety issue: No ]
Change History	Complete list of historical versions of study NCT00867399 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE
Original Secondary Outcome Measures ^ICMJE
Current Other Outcome Measures ^ICMJE
Original Other Outcome Measures ^ICMJE

Descriptive Information
Brief Title ^ICMJE	A Safety and Tolerability Study of ABT-126 in Elderly
Official Title ^ICMJE	A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects
Brief Summary	The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.
Detailed Description
Study Type ^ICMJE	Interventional
Study Phase	Phase 1
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Condition ^ICMJE	Alzheimer's Disease
Intervention ^ICMJE	Drug: ABT-126 See arm for details Other Name: ABT-126
Study Arm (s)	Active Comparator: 20mg of ABT-126 QD 20 mg of ABT-126 QD for 10 days Intervention: Drug: ABT-126 Active Comparator: 30mg and 45mg ABT-126 QD 30 mg and 45mg of ABT-126 QD for 21 days Intervention: Drug: ABT-126
Publications *
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	30
Completion Date
Primary Completion Date	May 2009 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	65 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT00867399
Other Study ID Numbers ^ICMJE	M10-717
Has Data Monitoring Committee
Responsible Party	Daniel Llano, MD, PhD, Associate Medical Director, Abbott
Study Sponsor ^ICMJE	Abbott
Collaborators ^ICMJE
Investigators ^ICMJE
Information Provided By	Abbott
Verification Date	September 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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