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Cytokine Inhibitor
XPro1595 for Alzheimer's Disease
Phase 2
Waitlist Available
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
No Placebo-Only Group
Summary
This trial tests XPro1595, a drug for Alzheimer's Disease, on people who were in previous studies. It aims to see if regular injections can reduce brain inflammation and improve memory and daily activities.
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.
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.
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ weeks 55, or 74 in the ole study
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~weeks 55, or 74 in the ole study
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of participants who experience adverse events and serious adverse events
Secondary study objectives
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 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Alzheimer's Disease (AD) include cholinesterase inhibitors (e.g., donepezil, rivastigmine) and NMDA receptor antagonists (e.g., memantine). Cholinesterase inhibitors work by increasing levels of acetylcholine, a neurotransmitter important for memory and learning, thereby improving cognitive function.
NMDA receptor antagonists help regulate glutamate activity to prevent excitotoxicity, which can damage neurons. Treatments like XPro1595, a selective inhibitor of soluble tumor necrosis factor (sTNF), aim to reduce neuroinflammation, which is believed to contribute to AD progression.
Reducing neuroinflammation can potentially slow down neuronal damage and improve cognitive outcomes. These mechanisms are crucial for AD patients as they target different aspects of the disease pathology, offering a multifaceted approach to managing symptoms and potentially altering disease progression.
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Who is running the clinical trial?
Inmune Bio, Inc.Lead Sponsor
6 Previous Clinical Trials
332 Total Patients Enrolled
2 Trials studying Tauopathies
201 Patients Enrolled for Tauopathies
Tara LehnerStudy DirectorINmune Bio
2 Previous Clinical Trials
30 Total Patients Enrolled
1 Trials studying Tauopathies
Patricia HopkinsStudy DirectorINmune Bio
2 Previous Clinical Trials
201 Total Patients Enrolled
2 Trials studying Tauopathies
201 Patients Enrolled for Tauopathies
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My medications for mild cognitive impairment or Alzheimer's disease will stay the same during this study.I can follow the study's procedures and assessments.I don't have any health issues that could affect my safety in the study.I am willing and able to agree to participate in the study, or my legal representative can consent for me.I will use effective birth control during and for 90 days after treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: 1.0 mg/kg XPro1595
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.