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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

March 19, 2009
October 31, 2010
March 2009
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
  • 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 ]
Complete list of historical versions of study NCT00867399 on ClinicalTrials.gov Archive Site
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A Safety and Tolerability Study of ABT-126 in Elderly
A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects

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

Not Provided
Interventional
Phase 1
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
Drug: ABT-126
See arm for details
Other Name: ABT-126
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
Not Provided
May 2009   (final data collection date for primary outcome measure)

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
Both
65 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00867399
M10-717
Not Provided
Daniel Llano, MD, PhD, Associate Medical Director, Abbott
Abbott
Not Provided
Not Provided
Abbott
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP