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

Alzheimer's Disease Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02220738
• Other study ID #: M13-334
• Status: Terminated
• Phase: Phase 1
• Start date: September 2014
• Est. completion date: March 2016

Study information

• Verified date: July 2021
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• ABT-957
ABT-957 administered twice-daily for 7 days

Other:
• Placebo for ABT-957
Placebo for ABT-957 administered twice-daily for 7 days

Locations

Country	Name	City	State
United States	Site Reference ID/Investigator# 129545	Glendale	California
United States	Site Reference ID/Investigator# 129641	New York	New York
United States	Site Reference ID/Investigator# 129435	Orlando	Florida
United States	Site Reference ID/Investigator# 144825	Salt Lake City	Utah

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

References & 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 o — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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