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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

Primary Purpose

Alzheimer's Disease

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-957
Placebo for ABT-957
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's Disease

Eligibility Criteria

55 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Site Reference ID/Investigator# 129545
  • Site Reference ID/Investigator# 129435
  • Site Reference ID/Investigator# 129641
  • Site Reference ID/Investigator# 144825

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABT-957

Placebo

Arm Description

ABT-957 administered twice-daily for 7 days

Placebo administered twice-daily for 7 days

Outcomes

Primary Outcome Measures

Pharmacokinetic evaluation of the two ABT-957 diastereomers
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)
Number of subjects with adverse events
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

Secondary Outcome Measures

Full Information

First Posted
August 18, 2014
Last Updated
July 2, 2021
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02220738
Brief Title
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
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 Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow subject enrollment
Study Start Date
September 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
Alzheimer's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-957
Arm Type
Experimental
Arm Description
ABT-957 administered twice-daily for 7 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo administered twice-daily for 7 days
Intervention Type
Drug
Intervention Name(s)
ABT-957
Intervention Description
ABT-957 administered twice-daily for 7 days
Intervention Type
Other
Intervention Name(s)
Placebo for ABT-957
Intervention Description
Placebo for ABT-957 administered twice-daily for 7 days
Primary Outcome Measure Information:
Title
Pharmacokinetic evaluation of the two ABT-957 diastereomers
Description
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)
Time Frame
Day 7
Title
Number of subjects with adverse events
Description
Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study
Time Frame
Routinely for the duration of the study, about 7 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nuno Mendonca, MD
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Site Reference ID/Investigator# 129545
City
Glendale
State/Province
California
ZIP/Postal Code
91206
Country
United States
Facility Name
Site Reference ID/Investigator# 129435
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 129641
City
New York
State/Province
New York
ZIP/Postal Code
10019
Country
United States
Facility Name
Site Reference ID/Investigator# 144825
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
30052328
Citation
Lon HK, Mendonca N, Goss S, Othman AA, Locke C, Jin Z, Rendenbach-Mueller B. Pharmacokinetics, Safety, Tolerability, and Pharmacodynamics of Alicapistat, a Selective Inhibitor of Human Calpains 1 and 2 for the Treatment of Alzheimer Disease: An Overview of Phase 1 Studies. Clin Pharmacol Drug Dev. 2019 Apr;8(3):290-303. doi: 10.1002/cpdd.598. Epub 2018 Jul 27.
Results Reference
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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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