Clinical trial NCT02573740: 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
Overall status: TERMINATED
Phase: PHASE1
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Alzheimer's Disease
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2015-10-12
Enrollment: 8
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Percentage of participants reporting treatment-emergent adverse events
timeFrame: For approximately 84 days
measure: Level of spectrin breakdown product-145 (SBDP-145)
timeFrame: 84 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Site Reference ID/Investigator# 143180
state: California
city: Orlando
country: United States
facility: Site Reference ID/Investigator# 143178
state: Florida
city: The Villages
country: United States
facility: Site Reference ID/Investigator# 149484
state: Florida
city: Marlton
country: United States
facility: Site Reference ID/Investigator# 143181
state: New Jersey
city: Cincinnati
country: United States
facility: Site Reference ID/Investigator# 143182
state: Ohio
city: Dallas
country: United States
facility: Site Reference ID/Investigator# 149481
state: Texas
city: Orem
country: United States
facility: Site Reference ID/Investigator# 143254
state: Utah
city: Salt Lake City
country: United States
facility: Site Reference ID/Investigator# 143179
state: Utah
city: Spokane
country: United States
facility: Site Reference ID/Investigator# 143177
state: Washington
Study officials:
affiliation: AbbVie
name: Nuno Mendonca, MD
role: STUDY_DIRECTOR
References:
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.