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Cytokine Inhibitor

XPro1595 for Alzheimer's Disease

Phase 2
Recruiting
Research Sponsored by Inmune Bio, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up weeks 55, or 74 in the ole study
Awards & highlights

Study Summary

This trial will assess if a drug called XPro1595 can improve cognition, functioning & brain quality in people with Alzheimer's.

Who is the study for?
This trial is for individuals who completed a previous XPro1595 study for Alzheimer's, can consent (or have a representative do so), and have a partner to assist them. They must maintain stable doses of current Alzheimer's medications and agree to contraception if applicable. Those with unstable medical conditions or unable to follow the study plan are excluded.Check my eligibility
What is being tested?
The Phase 2 trial tests the long-term safety and effectiveness of XPro1595 on cognitive function, daily activities, and brain health in people with Alzheimer's Disease. It’s an open-label extension meaning everyone gets the drug and there’s no placebo comparison.See study design
What are the potential side effects?
While specific side effects aren't listed here, participants will be monitored for any adverse reactions due to XPro1595 which could range from mild symptoms like headaches or nausea to more serious ones affecting organ functions.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 55, or 74 in the ole study
This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 55, or 74 in the ole study for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants who experience adverse events and serious adverse events
Secondary outcome measures
To evaluate the change Change from Baseline on the Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS- MCI- ADL)
To evaluate the change in Everyday Cognition (ECog) following open-label administration of XPro1595
Cognition
+6 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Experimental: 1.0 mg/kg XPro1595Experimental Treatment1 Intervention
Patients will receive XPro1595.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
XPro1595
2019
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Inmune Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
339 Total Patients Enrolled
2 Trials studying Brain Diseases
201 Patients Enrolled for Brain Diseases
Tara LehnerStudy DirectorINmune Bio
2 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Brain Diseases
Patricia HopkinsStudy DirectorINmune Bio
2 Previous Clinical Trials
201 Total Patients Enrolled
2 Trials studying Brain Diseases
201 Patients Enrolled for Brain Diseases

Media Library

XPro1595 (Cytokine Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05522387 — Phase 2
Brain Diseases Research Study Groups: Experimental: 1.0 mg/kg XPro1595
Brain Diseases Clinical Trial 2023: XPro1595 Highlights & Side Effects. Trial Name: NCT05522387 — Phase 2
XPro1595 (Cytokine Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05522387 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of participants are most suitable for this research endeavor?

"This study seeks to enrol 261 individuals with neurodegenerative diseases who are aged between 55 and 86."

Answered by AI

Is this experimentation currently enrolling volunteers?

"According to information hosted on clinicaltrials.gov, this trial is currently in the process of recruiting patients and was first published February 21st 2023 with a recent update recorded on August 23rd 2023."

Answered by AI

Is enrollment open to those over 45 years of age in this medical experiment?

"Applicants between the ages of 55 and 86 may participate in this study. In comparison, there are 224 trials associated with individuals under 18 years old and 1196 studies for those over 65."

Answered by AI

Can you provide a count of the Canadian medical facilities administering this clinical investigation?

"At the present time, there are 5 trial sites recruiting patients. Conveniently located in Ivanhoe, Perth and Toronto as well as an additional 5 locations; it is encouraged that participants choose a site close to them to reduce travel strain."

Answered by AI

Has the U.S. Food and Drug Administration sanctioned the 1.0 mg/kg dosage of XPro1595?

"Our evaluative team at Power has given Experimental: 1.0 mg/kg XPro1595 a safety rating of 2 as there is some evidence confirming its safety, but none backing up its efficacy due to this being a Phase 2 trial."

Answered by AI

What is the cap on participant numbers for this trial?

"Affirmative, the public information hosted on clinicaltrials.gov notes that enrolment for this medical study is ongoing. This trial was initially posted to be conducted in February 2021 and has been recently updated as of August 2023. 261 participants are needed between 5 different sites."

Answered by AI
~165 spots leftby May 2026