NCT02573740

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Dec 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

9 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 12, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

6 months

First QC Date

October 8, 2015

Last Update Submit

July 2, 2021

Conditions

Alzheimer's DiseaseMild Cognitive Impairment

Keywords

Mild Cognitive ImpairmentAlzheimer's Disease

Outcome Measures

Primary Outcomes (2)

  • Percentage of participants reporting treatment-emergent adverse events

    For approximately 84 days

  • Level of spectrin breakdown product-145 (SBDP-145)

    84 days

Study Arms (2)

ABT-957

EXPERIMENTAL

ABT-957 given twice a day for 84 days

Drug: ABT-957

Placebo

PLACEBO COMPARATOR

Placebo given twice a day for 84 days

Other: Placebo

Interventions

ABT-957DRUG
ABT-957
PlaceboOTHER
Placebo

Eligibility Criteria

Age55 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

Site Reference ID/Investigator# 143180

Cypress, California, 90630, United States

Location

Site Reference ID/Investigator# 143178

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 149484

The Villages, Florida, 32162, United States

Location

Site Reference ID/Investigator# 143181

Marlton, New Jersey, 08053, United States

Location

Site Reference ID/Investigator# 143182

Cincinnati, Ohio, 45255, United States

Location

Site Reference ID/Investigator# 149481

Dallas, Texas, 75231, United States

Location

Site Reference ID/Investigator# 143254

Orem, Utah, 84058, United States

Location

Site Reference ID/Investigator# 143179

Salt Lake City, Utah, 84107, United States

Location

Site Reference ID/Investigator# 143177

Spokane, Washington, 99202, United States

Location

Related Publications (1)

  • 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.

    PMID: 30052328RESULT

MeSH Terms

Conditions

Alzheimer DiseaseCognitive Dysfunction

Interventions

alicapistat

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental DisordersCognition Disorders

Study Officials

  • Nuno Mendonca, MD

    AbbVie

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 8, 2015

First Posted

October 12, 2015

Study Start

December 1, 2015

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations

US(9)