XPro-AD-02

• Research type

  Research Study

• Full title

  A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients with Mild Alzheimer’s Disease with Biomarkers of Inflammation

• IRAS ID

  1006544

• Contact name

  Gary Cai

• Contact email

  gcai@inmunebio.com

• Sponsor organisation

  INmune Bio Inc.

• Eudract number

  2022-003632-37

• Clinicaltrials.gov Identifier

  NCT05318976

• Research summary

  This study is designed as a double-blind, randomized, placebo-controlled, study investigating the safety, tolerability, and efficacy of XPro1595 in patients with mild Alzheimer's Disease (AD) with inflammation (ADi). The planned dose is 1.0 mg/kg of XPro1595 and matching placebo. Patients are expected to be in the study for ~33 weeks (screening, double-blind period and follow-up). Those that complete all 24 weeks of the double-blind study will be eligible for a one-year open label extension of XPro1595 (regardless of what they received during the double-blind study).

• REC name

  East Midlands - Leicester South Research Ethics Committee

• REC reference

  23/EM/0061

• Date of REC Opinion

  25 Aug 2023

• REC opinion

  Further Information Favourable Opinion