Ended Therapeutic exploratory (Phase II) Early Alzheimer’s Disease with Biomarkers of Inflammation

A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients with Early Alzheimer’s Disease with Biomarkers of Inflammation

EU CTIS ID: 2023-505396-71-00

What this study is testing

To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi

  • Therapeutic exploratory (Phase II)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 1. Adult patients 50 years to ≤ 85 years of age at the time of consent 2. Diagnosed with MCI of probable Alzheimer’s disease (Jack et al. 2018; NIA-AA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018). (NIA - AA); 3. CDR global rating at screening of 0.5 or 1 4. MMSE > 22; 5. ECog memory subscale items mean > 1.5 6. Presence of at least 1 inflammatory biomarker: • hsCRP > 1.5 mg/L • ESR > 10 mm/h • HbA1C > 6 DCCT % • At least 1 APOE4 allele

You likely can't join if

  • 1. Have any contraindications to MRI scanning, including cardiac pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac devices other than those approved as safe for use in MRI scanners). 2. Have any evidence of other clinically significant lesion(s) that could confound or indicate a dementia diagnosis other than AD on brain CT and/or MRI at Screening. 3. Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility. 4. Lifetime history of a major psychiatric disorder including schizophrenia and bipolar disorder. Major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime. Major depressive episode during the past 5 years that is judged by the clinical team unlikely to have been part of Alzheimer’s prodrome. History of suicidal behavior, or answer of ‘yes” to C-SSRS suicidal ideation items 4 or 5 within 12 months of screening. 5. History of substance abuse within 12 months; use of cannabis or cannabis products within 6months of consent. 6. Have taken within the last 90 days from Day 1: corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline, first- or second-generation antipsychotics (e.g., aripripozole) or aducanumab.

The study team makes the final eligibility decision.

Where it's taking place

  • United Kingdom
  • Canada
  • Australia

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include United Kingdom; Canada; Australia. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.