Phase 1b open-label, dose-Identification study of XPro1595 in patients with mild to moderate Alzheimer’s disease with elevated high sensitivity C-reactive protein in blood

Occurring Dates
to
Participant Duration
Weekly visit for 12 weeks. 9-month extension study is available for participants benefitting from treatment.
State of study
New South Wales
Queensland
South Australia
Western Australia
Victoria
Overview

The study is designed as a multicentre, phase 1b open-label study. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with mild to moderate Alzheimer's disease and elevated blood levels of the inflammatory biomarkers such as high sensitivity c-reactive protein (hsCRP).

XPro1595 is a second-generation inhibitor of tumor necrosis factor (TNF) that selectively neutralizes soluble TNF, an inflammatory factor implicated in Alzheimer's pathology.

A key element of this study is to identify people with Alzheimer's disease that are most likely to benefit from XPro1595 treatment. Enrollment is limited to patients with evidence of peripheral inflammation using elevated blood inflammatory biomarkers. For instance, hsCRP is an inflammatory biomarker elevated in the blood of some Alzheimer's patients and elevated CRP has been shown to predict response to TNF inhibitors in multiple other diseases.

Alzheimer's patients with elevated blood inflammatory biomarkers will be enrolled in a 12-week study to determine the safety and the ability of XPro1595 to reduce neuroinflammation using a combination of invasive and non-invasive biomarkers of inflammation. The study will identify the dose of XPro1595 to be used in a larger Phase II disease modification study.

Participants who are benefitting from treatment can enroll to a 9-month extension study.

Further information

The study is being conducted at different sites across Australia. If you'd like to learn more, let us know via e-mail to [email protected], and the research team will be in touch.

To watch the preliminary study data released, visit: https://www.youtube.com/watch?v=gahyal2WhY0

This study has been approved by the Alfred Human Research Ethics Committee (reference: Project 630/18) and Central Adelaide Health Network Human Research Ethics Committee (reference number: HREC/19/CALHN/362).

Study Address
New South Wales
KaRa MINDS
Macquarie Park, New South Wales, Australia, 2113
Principal Investigator: Dr. Rosalyn Lai

Queensland
Mater Medical Research Institute
Brisbane, Queensland, Australia, 4101
Principal Investigator: Prof. Peter Nestor

South Australia
Central Adelaide Local Health Network
Woodville, South Australia, Australia, 5011
Principal Investigator: Dr. Cathy Short

Victoria
Alfred Heath
Melbourne, Victoria, Australia, 3004
Principal Investigator: Prof. Terrence O'Brien

Eastern Clinical Research Unit
Melbourne, Victoria, Australia, 3128
Principal Investigator: Prof. Amy Brodtman
Full Name
Jaybee David
Institute
Neuroscience Trials Australia
Phone Number
(03) 8344 8388