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

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Alzheimer's Disease, Mild Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02573740

Run by

AbbVie

People needed

8

Starts

2015-12-01

Expected to finish

2016-06-01

Last updated by the study team

2021-07-06

Who can join

Age: 55 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Site Reference ID/Investigator# 143180 — Cypress, California, United States
• Site Reference ID/Investigator# 143178 — Orlando, Florida, United States
• Site Reference ID/Investigator# 149484 — The Villages, Florida, United States
• Site Reference ID/Investigator# 143181 — Marlton, New Jersey, United States
• Site Reference ID/Investigator# 143182 — Cincinnati, Ohio, United States
• Site Reference ID/Investigator# 149481 — Dallas, Texas, United States
• Site Reference ID/Investigator# 143254 — Orem, Utah, United States
• Site Reference ID/Investigator# 143179 — Salt Lake City, Utah, United States
• Site Reference ID/Investigator# 143177 — Spokane, Washington, United States

Full record on ClinicalTrials.gov

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