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Trial record 2 of 2 for:    ABT-957

Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment

This study has been terminated.
(Insufficient target engagement of ABT-957 (preclinical data))
Sponsor:
Information provided by (Responsible Party):
AbbVie
ClinicalTrials.gov Identifier:
NCT02573740
First received: October 8, 2015
Last updated: June 30, 2016
Last verified: June 2016
  Purpose
This is a Phase 1, multicenter, randomized, double-blind, placebo-controlled, multiple dose study of ABT-957 in participants with mild Alzheimer's disease (AD) and Mild Cognitive Impairment (MCI) due to AD.

Condition Intervention Phase
Alzheimer's Disease
Mild Cognitive Impairment
Drug: ABT-957
Other: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Study to Evaluate the Safety, Tolerability and the Effects on Cerebrospinal Fluid Spectrin Breakdown Product-145 Levels of Multiple Doses of ABT-957 in Subjects With Mild Alzheimer's Disease and Mild Cognitive Impairment Due to Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by AbbVie:

Primary Outcome Measures:
  • Percentage of participants reporting treatment-emergent adverse events [ Time Frame: For approximately 84 days ]
  • Level of spectrin breakdown product-145 (SBDP-145) [ Time Frame: 84 days ]

Enrollment: 8
Study Start Date: December 2015
Study Completion Date: June 2016
Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ABT-957
ABT-957 given twice a day for 84 days
Drug: ABT-957
Placebo Comparator: Placebo
Placebo given twice a day for 84 days
Other: Placebo

  Eligibility

Ages Eligible for Study:   55 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female participants must have negative results for pregnancy test performed on a serum sample obtained at Screening
  • Body Mass Index is 18.0 to 35.0 at Screening
  • Meets the National Institute on Aging and the Alzheimer's Association (NIA-AA) criteria for probable Alzheimer's disease (AD).
  • Meets the NIA-AA core clinical criteria for Mild Cognitive Impairment due to AD

Exclusion Criteria:

  • Use of any strong inhibitors of drug metabolizing enzymes within 30 days prior to study drug administration
  • Consumption of alcohol within 24 hours prior to study drug administration
  • Positive screen for non-prescribed drugs of abuse or alcohol
  • The participant has clinically significant abnormal laboratory values at Screening as determined by the investigator
  • History of a drug or alcohol abuse within 6 months prior to study drug administration
  • Current diagnosis of major depression or other major psychiatric disorder
  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: NCT02573740

Locations
United States, California
Site Reference ID/Investigator# 143180
Cypress, California, United States, 90630
United States, Florida
Site Reference ID/Investigator# 143178
Orlando, Florida, United States, 32806
Site Reference ID/Investigator# 149484
The Villages, Florida, United States, 32162
United States, New Jersey
Site Reference ID/Investigator# 143181
Marlton, New Jersey, United States, 08053
United States, Ohio
Site Reference ID/Investigator# 143182
Cincinnati, Ohio, United States, 45255
United States, Texas
Site Reference ID/Investigator# 149481
Dallas, Texas, United States, 75231
United States, Utah
Site Reference ID/Investigator# 143254
Orem, Utah, United States, 84058
Site Reference ID/Investigator# 143179
Salt Lake City, Utah, United States, 84107
United States, Washington
Site Reference ID/Investigator# 143177
Spokane, Washington, United States, 99202
Sponsors and Collaborators
AbbVie
Investigators
Study Director: Nuno Mendonca, MD AbbVie
  More Information

Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT02573740     History of Changes
Other Study ID Numbers: M13-730
Study First Received: October 8, 2015
Last Updated: June 30, 2016

Keywords provided by AbbVie:
Mild Cognitive Impairment
Alzheimer's Disease

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

ClinicalTrials.gov processed this record on April 28, 2017