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Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors

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ClinicalTrials.gov Identifier: NCT02220738
Recruitment Status : Terminated (Slow subject enrollment)
First Posted : August 20, 2014
Last Update Posted : June 16, 2016
Sponsor:
Information provided by (Responsible Party):
AbbVie

Brief Summary:
This study is designed to evaluate the safety, tolerability and pharmacokinetics of multiple doses of ABT-957 in subjects with mild to moderate Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: ABT-957 Other: Placebo for ABT-957 Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multiple-Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics of ABT-957 in Subjects With Mild-to-Moderate Alzheimer's Disease on Stable Doses of Acetylcholinesterase Inhibitors
Study Start Date : September 2014
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016


Arm Intervention/treatment
Experimental: ABT-957
ABT-957 administered twice-daily for 7 days
Drug: ABT-957
ABT-957 administered twice-daily for 7 days

Placebo Comparator: Placebo
Placebo administered twice-daily for 7 days
Other: Placebo for ABT-957
Placebo for ABT-957 administered twice-daily for 7 days




Primary Outcome Measures :
  1. Pharmacokinetic evaluation of the two ABT-957 diastereomers [ Time Frame: Day 7 ]
    maximum observed plasma concentration (Cmax), time to Cmax (peak time, Tmax), plasma concentration at the end of the dosing interval (Ctrough), the area under the plasma concentration-time curve (AUC) during each dosing interval (AUC0-12 and AUC12-24)

  2. Number of subjects with adverse events [ Time Frame: Routinely for the duration of the study, about 7 months ]
    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study



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Ages Eligible for Study:   55 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Meets the National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association criteria for probable Alzheimer's disease (AD);
  • Has a Mini-Mental State Examination total score of 16 to 26;
  • Has a Modified Hachinski Ischemia Scale score of ≤ 4;
  • Is taking a stable dose of donepezil, galantamine or rivastigmine for at least 30 days;
  • Has had a computerized tomography or magnetic resonance imaging. The scan must not show evidence for an alternative etiology for dementia;
  • With the exception of a diagnosis of mild-to-moderate AD and the presence of stable medical conditions, is in general good health.

Exclusion Criteria:

  • Positive screen for drugs of abuse, alcohol or cotinine;
  • Females must not have positive results for pregnancy;
  • Focal neurological signs on examination;
  • Has a clinically significant abnormal value, in serum chemistry, hematology or urinalysis;
  • History of any significant neurologic disease other than AD;
  • History of head trauma, motor vehicle accident, concussion.

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): NCT02220738


Locations
United States, California
Site Reference ID/Investigator# 129545
Glendale, California, United States, 91206
United States, Florida
Site Reference ID/Investigator# 129435
Orlando, Florida, United States, 32806
United States, New York
Site Reference ID/Investigator# 129641
New York, New York, United States, 10019
United States, Utah
Site Reference ID/Investigator# 144825
Salt Lake City, Utah, United States, 84106
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Nuno Mendonca, MD AbbVie

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02220738     History of Changes
Other Study ID Numbers: M13-334
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: June 16, 2016
Last Verified: June 2016

Keywords provided by AbbVie:
Alzheimer's Disease

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs