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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
History of Changes
  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 Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: Yes ]
  • Assess the Pharmacokinetics [ Time Frame: Study Days -1 thru Day 28 ] [ Designated as safety issue: No ]

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
Other Name: ABT-126
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
Other Name: ABT-126

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00867399

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

No publications provided

Responsible Party: Daniel Llano, MD, PhD, Associate Medical Director, Abbott
ClinicalTrials.gov Identifier: NCT00867399     History of Changes
Other Study ID Numbers: M10-717
Study First Received: March 19, 2009
Last Updated: October 31, 2010
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 18, 2013