A Safety and Tolerability Study of ABT-126 in Elderly - Full Text View

Sponsored by:	Abbott
Information provided by:	Abbott
ClinicalTrials.gov Identifier:	NCT00867399

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 I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Single Group Assignment
Official Title:	A Multiple Dose Study of Safety, Tolerability and Pharmacokinetics of ABT-126 in Elderly Subjects

Resource links provided by NLM:

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

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
20mg of ABT-126 QD: Active Comparator 20 mg of ABT-126 QD for 10 days	Drug: ABT-126 See arm for details
30mg and 45mg ABT-126 QD: Active Comparator 30 mg and 45mg of ABT-126 QD for 21 days	Drug: ABT-126 See arm for details

Eligibility

Criteria

Inclusion Criteria:

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

Orlando, Florida, United States, 32809

Sponsors and Collaborators

Abbott

More Information

No publications provided

Responsible Party:	Abbott ( Daniel Llano, MD, PhD, Associate Medical Director )
Study ID Numbers:	M10-717
Study First Received:	March 19, 2009
Last Updated:	May 15, 2009
ClinicalTrials.gov Identifier:	NCT00867399 History of Changes
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Central Nervous System Diseases
Neurodegenerative Diseases

Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:

Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Alzheimer Disease
Central Nervous System Diseases

Neurodegenerative Diseases
Tauopathies
Brain Diseases
Dementia

ClinicalTrials.gov processed this record on August 25, 2009