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Study of XPro1595 for Patients with Early Alzheimer's Disease and Inflammation Markers

Fast replyInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of a treatment for Early Alzheimer's Disease, a condition that affects memory and thinking skills. The treatment being tested is called XPro1595, which is a type of protein designed to help with inflammation in the brain. Inflammation is a response by the body's immune system that can sometimes cause harm if it happens in the brain. The study will compare the effects of XPro1595 with a placebo, which looks like the treatment but does not contain the active ingredient.

The purpose of the study is to see how well XPro1595 works in improving cognitive performance, which includes memory and other mental abilities, in people with early Alzheimer's Disease. Participants in the study will receive either the XPro1595 treatment or a placebo through an injection. The study will last for about 33 weeks, during which participants will have regular assessments to monitor changes in their cognitive abilities.

Throughout the study, participants will undergo various tests to measure their memory and thinking skills. These tests will help researchers understand if XPro1595 can make a difference in managing symptoms of early Alzheimer's Disease. The study aims to provide valuable information on whether this new treatment can help improve the quality of life for those affected by this condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient will be randomly assigned to receive either the XPro1595 medication or a placebo. The placebo is a solution that looks like the medication but does not contain the active ingredient.

    The study is designed to be double-blind, meaning neither the patient nor the researchers will know which treatment the patient is receiving.

  2. Step 2

    Medication administration

    The patient will receive the assigned treatment as a solution for injection. The frequency and dosage will be determined by the study protocol, which is not specified in the provided data.

  3. Step 3

    Monitoring and assessments

    Throughout the study, the patient's cognitive performance will be assessed using various tests, including the International Shopping List Test, Digit Span, Category Fluency Test, Letter Fluency Test, Trail Making Test, and Digit Symbol Coding Test.

    These assessments will help determine any changes in cognitive abilities from the start of the study to week 24.

  4. Step 4

    Secondary assessments

    Additional assessments will be conducted to evaluate changes in the Clinical Dementia Rating Scale, Everyday Cognition, and the Neuropsychiatric Inventory caregiver items from the start of the study to week 24.

  5. Step 5

    Study duration

    The study is expected to continue until July 31, 2025. The patient's participation will involve regular visits and assessments throughout this period.

Who can join the trial?

9 criteria

  • Adults aged between 50 and 85 years old.
  • Diagnosed with MCI, which stands for Mild Cognitive Impairment, likely due to Alzheimer's disease, or mild dementia. This means the person is in the early stages of Alzheimer's.
  • A CDR global rating of 0.5 or 1 at screening. CDR stands for Clinical Dementia Rating, which is a scale used to assess the severity of dementia symptoms.
  • An MMSE score greater than 22. MMSE stands for Mini-Mental State Examination, a test used to measure cognitive function.
  • An ECog memory subscale items mean greater than 1.5. ECog is a questionnaire that evaluates everyday memory and thinking abilities.
  • Presence of at least one inflammatory biomarker. Biomarkers are substances in the body that can indicate a disease or condition. The specific biomarkers include:
    • hsCRP greater than 1.5 mg/L. hsCRP stands for high-sensitivity C-reactive protein, a marker of inflammation in the body.
    • ESR greater than 10 mm/h. ESR stands for erythrocyte sedimentation rate, another marker of inflammation.
    • HbA1C greater than 6 DCCT %. HbA1C is a measure of blood sugar levels over time.
    • At least one APOE4 allele. APOE4 is a gene variant associated with a higher risk of Alzheimer's disease.

Who cannot join the trial?

4 criteria

  • Patients who do not have Early Alzheimer's Disease with specific signs of inflammation cannot participate.
  • Individuals outside the specified age range for the study are not eligible.
  • Participants who do not meet the required health conditions for the study will be excluded.
  • People who are part of a vulnerable population that the study does not include will not be able to join.
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Investigated drugs

XPro1595 is a medication being studied for its potential to improve cognitive performance in patients with early Alzheimer's Disease. It is designed to target and reduce inflammation in the brain, which is believed to play a role in the progression of Alzheimer's Disease. The study aims to determine if this medication can help slow down or improve the symptoms associated with cognitive decline in these patients.

What is already known about the treatment

XPro1595 – XPro1595 is administered as an injection and is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease, particularly in patients with biomarkers of inflammation. The medication is not yet widely recognized in medical literature as it is still under investigation. It is primarily indicated for improving cognitive performance in Alzheimer's patients. At the molecular level, XPro1595 works by targeting and neutralizing specific inflammatory proteins that may contribute to the progression of Alzheimer's disease. It is classified pharmacologically as an anti-inflammatory agent.

Investigated diseases

Early Alzheimer's Disease with Biomarkers of Inflammation – This condition is characterized by the initial stages of Alzheimer's disease, where cognitive decline begins to manifest. It is associated with specific biomarkers indicating inflammation in the brain. Patients may experience mild memory loss, difficulties in problem-solving, and challenges in performing daily tasks. As the disease progresses, these symptoms can become more pronounced, affecting language and spatial abilities. The presence of inflammation biomarkers suggests an underlying inflammatory process that may contribute to the disease's progression. Understanding these biomarkers is crucial for developing targeted interventions to slow cognitive decline.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505396-71-00Protocol codeXPro1595-AD-02Estimated enrolment189 patientsSponsorInmune Bio Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).