NCT02220738

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2014

Geographic Reach
1 country

4 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

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
Last Updated

July 6, 2021

Status Verified

July 1, 2021

Enrollment Period

1.5 years

First QC Date

August 18, 2014

Last Update Submit

July 2, 2021

Conditions

Alzheimer's Disease

Keywords

Alzheimer's Disease

Outcome Measures

Primary Outcomes (2)

  • 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)

    Day 7

  • Number of subjects with adverse events

    Subjects will be monitored for clinical and laboratory evidence of adverse events throughout the study

    Routinely for the duration of the study, about 7 months

Study Arms (2)

ABT-957

EXPERIMENTAL

ABT-957 administered twice-daily for 7 days

Drug: ABT-957

Placebo

PLACEBO COMPARATOR

Placebo administered twice-daily for 7 days

Other: Placebo for ABT-957

Interventions

ABT-957DRUG

ABT-957 administered twice-daily for 7 days

ABT-957
Placebo for ABT-957OTHER

Placebo for ABT-957 administered twice-daily for 7 days

Placebo

Eligibility Criteria

Age55 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Site Reference ID/Investigator# 129545

Glendale, California, 91206, United States

Location

Site Reference ID/Investigator# 129435

Orlando, Florida, 32806, United States

Location

Site Reference ID/Investigator# 129641

New York, New York, 10019, United States

Location

Site Reference ID/Investigator# 144825

Salt Lake City, Utah, 84106, 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 Disease

Interventions

alicapistat

Condition Hierarchy (Ancestors)

DementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Nuno Mendonca, MD

    AbbVie

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

September 1, 2014

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

July 6, 2021

Record last verified: 2021-07

Locations

US(4)