OHSU

IRB #

IRB00009333

Title

A Placebo-controlled, Double-blind, Parallel-group, Bayesian Adaptive Randomization Design and Dose Regimen-finding Study to Evaluate Safety, Tolerability and Efficacy of BAN2401 in Subjects With Early Alzheimer’s Disease. BAN2401-G000-201

Principal Investigator

Deniz Erten-Lyons

Study Purpose

The purpose of this study is to learn more about Alzheimer’s disease and a drug called BAN2401. This study is designed to determine if the study drug has a benefit on a person’s cognitive status, and to assess the safety and tolerability of the study drug for subjects with early Alzheimer’s disease (Mild Cognitive Impairment due to Alzheimer’s disease or mild Alzheimer’s disease).

Medical Condition(s)

Alzheimer's disease

Eligibility Criteria

• Male or Female from the ages of 50 to 90 years
• Must have a diagnosis of Mild Cognitive Impairment or mild Alzheimer's Disease.
• No significant, uncontrolled additional medical conditions.
• No history of stroke.
• If taking an acetylcholinesterase inhibitor and/or memantine, must be on a stable dose.
• Must have a study partner.
• Must be able to undergo MRI scanning

Age Range

50 - 90

Healthy Volunteers Needed

No

Duration of Participation

23 months, 43 visits (plus 1 PET scan, 9 MRI, and 3 optional lumbar punctures)

Minors Included

No

Contact

Lisa Loree
Phone: 503-494-7615
Email: adresearch@ohsu.edu

Sponsor

Eisai Inc.

Recruitment End

01/01/2016

Compensation Provided

Yes

Compensation

Subjects will be reimbursed for transportation for each study visit completed. The amount will vary based on the procedures performed at that visit.


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