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A Safety and Tolerability Study of ABT-126 in Elderly

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00867399
First Posted: March 23, 2009
Last Update Posted: November 2, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  Purpose
The objectives of this study are to assess the safety, tolerability and pharmacokinetics of ABT-126 in elderly subjects.

Condition Intervention Phase
Alzheimer's Disease Drug: ABT-126 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects

Resource links provided by NLM:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]
  • Assess the Pharmacokinetics [ Time Frame: Study Days -1 thru Day 28 ]

Enrollment: 30
Study Start Date: March 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 20mg of ABT-126 QD
20 mg of ABT-126 QD for 10 days
Drug: ABT-126
See arm for details
Active Comparator: 30mg and 45mg ABT-126 QD
30 mg and 45mg of ABT-126 QD for 21 days
Drug: ABT-126
See arm for details

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00867399


Locations
United States, Florida
Site Reference ID/Investigator# 17283
Orlando, Florida, United States, 32809
Sponsors and Collaborators
Abbott
  More Information

Responsible Party: Daniel Llano, MD, PhD, Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00867399     History of Changes
Other Study ID Numbers: M10-717
First Submitted: March 19, 2009
First Posted: March 23, 2009
Last Update Posted: November 2, 2010
Last Verified: September 2010

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders