What side effects are associated with this type of intervention?

Common treatments for Alzheimer's Disease include cholinesterase inhibitors (such as donepezil, rivastigmine, and galantamine) and NMDA receptor antagonists (such as memantine). These treatments can have side effects including nausea, vomiting, diarrhea, muscle cramps, fatigue, and insomnia. For treatments similar to XPro1595, which target neuroinflammation through TNF inhibition, potential side effects may include increased risk of infections, injection site reactions, and possible impacts on immune function. It is important to discuss these potential side effects with a healthcare provider to tailor the treatment plan to the patient's needs.

What prior FDA approvals exist?

The FDA has approved several treatments for Alzheimer's Disease, primarily focusing on symptom management rather than disease modification. Notably, aducanumab, an amyloid beta-directed antibody, was approved to target amyloid plaques in the brain, a hallmark of Alzheimer's pathology. While aducanumab's mechanism differs from XPro1595, which targets neuroinflammation through inhibition of soluble tumor necrosis factor (sTNF), both aim to modify disease processes. Other approved treatments include cholinesterase inhibitors (donepezil, rivastigmine, galantamine) and an NMDA receptor antagonist (memantine), which primarily address cognitive symptoms rather than underlying inflammation.

What other types of research exist?

Promising novel alternatives to XPro1595 for Alzheimer's Disease treatment in 2024 include: 1) Anti-amyloid antibodies such as aducanumab and lecanemab, which target amyloid-beta plaques. 2) Tau protein inhibitors like semorinemab, which aim to prevent tau tangles. 3) BACE inhibitors such as elenbecestat, which reduce amyloid-beta production. 4) Anti-inflammatory agents like ALZT-OP1, which target neuroinflammation. 5) Gene therapy approaches, including CRISPR-Cas9, which aim to modify genetic risk factors associated with AD.

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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

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

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 more

Awards & 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

Do I qualify?Apply below to find out

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.