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
  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:


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
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, see Learn About Clinical Studies.

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 August 20, 2014