search
Back to results

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

Primary Purpose

Alzheimer's Disease, Mild Cognitive Impairment

Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
ABT-957
Placebo
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 Mild Cognitive Impairment, Alzheimer's Disease

Eligibility Criteria

55 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Site Reference ID/Investigator# 143180
  • Site Reference ID/Investigator# 143178
  • Site Reference ID/Investigator# 149484
  • Site Reference ID/Investigator# 143181
  • Site Reference ID/Investigator# 143182
  • Site Reference ID/Investigator# 149481
  • Site Reference ID/Investigator# 143254
  • Site Reference ID/Investigator# 143179
  • Site Reference ID/Investigator# 143177

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ABT-957

Placebo

Arm Description

ABT-957 given twice a day for 84 days

Placebo given twice a day for 84 days

Outcomes

Primary Outcome Measures

Percentage of participants reporting treatment-emergent adverse events
Level of spectrin breakdown product-145 (SBDP-145)

Secondary Outcome Measures

Full Information

First Posted
October 8, 2015
Last Updated
July 2, 2021
Sponsor
AbbVie
search

1. Study Identification

Unique Protocol Identification Number
NCT02573740
Brief Title
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Terminated
Why Stopped
Insufficient target engagement of ABT-957 (preclinical data)
Study Start Date
December 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 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 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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ABT-957
Arm Type
Experimental
Arm Description
ABT-957 given twice a day for 84 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo given twice a day for 84 days
Intervention Type
Drug
Intervention Name(s)
ABT-957
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Percentage of participants reporting treatment-emergent adverse events
Time Frame
For approximately 84 days
Title
Level of spectrin breakdown product-145 (SBDP-145)
Time Frame
84 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
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# 143180
City
Cypress
State/Province
California
ZIP/Postal Code
90630
Country
United States
Facility Name
Site Reference ID/Investigator# 143178
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Site Reference ID/Investigator# 149484
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Site Reference ID/Investigator# 143181
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Site Reference ID/Investigator# 143182
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45255
Country
United States
Facility Name
Site Reference ID/Investigator# 149481
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Site Reference ID/Investigator# 143254
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
Site Reference ID/Investigator# 143179
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Site Reference ID/Investigator# 143177
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
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
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs