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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Pharmakologisches Studienzentrum Chemnitz GmbH Chemnitz Germany
Hospital Universitario De Salamanca Salamanca Spain
Bellvitge University Hospital L'hospitalet De Llobregat Spain
Hospital Universitario Y Politecnico La Fe Valencia Spain
Hospital Universitario De Navarra Pamplona Spain
NZOZ Neuro-Kard Ilkowski i Partnerzy Spółka Partnerska Lekarzy Poznan Poland

Other Sites

Site Name City Country Status
Fundacio Assistencial De Mutua De Terrassa Fpc Terrassa Spain
Mtz Clinical Research Powered By Pratia Warsaw Poland
FutureMeds GmbH Berlin Germany
Klinische Forschung Hamburg GmbH Hamburg Germany
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Centrum Medyczne Neuromed Sp. z o.o. Bydgoszcz Poland
AGE Centrum s.r.o. Olomouc Czechia
Clintrial s.r.o. Prague Czechia
A-Shine s.r.o. Plzen Czechia
Centre Hospitalier Universitaire De Toulouse Toulouse France
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Hospital Universitario Quironsalud Madrid Pozuelo De Alarcon Spain
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Pratia S.A. Skorzewo Poland
Hospital Ruber Juan Bravo Madrid Spain
Hospices Civils De Lyon Lyon France
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
HELIOS Kliniken Schwerin GmbH Schwerin Germany
Hopital Beaujon Clichy France
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Universitari De Santa Maria Lleida Spain
Revit Sp. z o.o. Bialystok Poland
Centrum Medyczne Senior Sopot Poland
Promente Sp. z o.o. Bydgoszcz Poland
Neuroprotect Sp. z o.o. Warsaw Poland
Centre Hospitalier Universitaire De Nantes Saint-Herblain France
Neuropsychiatrie s.r.o. Prague Czechia
Hospices Civils de Lyon (HCL) – Hôpital des Charpennes Villeurbanne France
Forbeli s.r.o. Prague Czechia
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Aevd shqpxc Prague Czechia
Mbvkm Bffxg Dggulzkw nqioukbwydhs aelyrkpouy sriyrl Banska Bystrica Slovakia
Jowoanm Sfkjy sytvgd Bratislava Slovakia
Kxrwtmbwj sknjlp Nova Dubnica Slovakia
Hpvbxjlb Pucuoa Spzd Vigo Spain
Agwlylupzu Pumaaaoa Hdgznbuq Dy Mzayqskof Marseille France
Hiixsdtf Unqnrovlmtfjjg Sxbwvnafoq &iaffhz Hmkyaoj da Havtbtvhglp STRASBOURG, Alsace France
Mcibmcyi Sze z oagh Oświęcim Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
16.10.2023
France France
Not recruiting
16.10.2023
Germany Germany
Not recruiting
16.10.2023
Poland Poland
Not recruiting
16.10.2023
Slovakia Slovakia
Not recruiting
16.10.2023
Spain Spain
Not recruiting
16.10.2023

Trial locations

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.

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 ID:
2023-505396-71-00
Protocol code:
XPro1595-AD-02
NCT ID:
NCT05318976
Trial Phase:
Therapeutic exploratory (Phase II)

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