A Study of XPro1595 in patients with early Alzheimer's disease with biomarkers of inflammation
Information about the drug that will be tested in the study
Administration
The drug will be administered via a subcutaneous injection (an injection under the skin) every week.
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- A subcutaneous injection of XPro1595 (1.0 mg/kg)
- A subcutaneous injection of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect).
Neither the participant nor their doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the safety, tolerability and efficacy of XPro1595 in people with early Alzheimer’s disease. The study will determine if XPro1595 could confer a benefit on cognition, function and biomarkers of white matter (a specific part of the brain).
How long will the treatment last?
- 23 weeks
What your involvement will entail?
- During the study, participants will be asked to complete some tests that will assess cognition, activities of daily living and neuropsychiatric symptoms (i.e. tests or scales like EMACC, E-Cog, ADCS-ADL, CDR, NPI)
- To undergo brain scan (MRI)
- To complete some laboratory and biological tests to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be between 50 and 85 years old
- Have a diagnosis of Mild Cognitive Impairment or probable Alzheimer’s disease or mild dementia, according to the NIAAA criteria
- Either currently or previously (in pre-AD condition) literate and capable of reading, writing, and communicating effectively with others
- Residence in an assisted living is allowed but participant must be able to perform most daily activities with minimal assistance
- Have a study partner who has a sufficient contact with the participant, is willing to participate in study procedures throughout the study duration (at least 4 hours per day and on at least 4 days per week).
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Any contraindications to brain scanning (i.e. cardiac pacemaker/defibrillator, metal implants)
- Receiving considerable help to carry out basic daily living activities either in the home or as a resident in a nursing home or similar facility
- History of a major psychiatric disorder such as schizophrenia and bipolar disorder
- History of suicide
- History of substance abuse within 12 months
- Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another Alzheimer’s disease clinical trial within the last 60 days
- A prior organ or stem cell transplant.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT05318976
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT05318976
https://euclinicaltrials.eu/ctis-public/view/2023-505396-71-00
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on September 2024.
This document has been reviewed by a member of the European Working Group of People with Dementia.
