A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

Phase 2

Recruiting

• Conditions: Alzheimer Disease; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Mild Cognitive Impairment

• Registration Number: NCT05318976
• Lead Sponsor: Inmune Bio, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-3-7
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 201

Inclusion Criteria

Inclusion Criteria:<br><br>To be eligible for study entry, patients must satisfy all of the following criteria:<br><br> - Adult patients 50 years to = 85 years of age at the time of consent;<br><br> - Meets the diagnostic criteria of MCI of probable Alzheimer's disease (Jack et al.<br> 2018; NIA-AA) or mild dementia as clinically described in McKhann, (2011) and<br> corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018).<br> (NIA-AA);<br><br> - Amyloid positive (documented in medical history or assessed during screening through<br> blood test);<br><br> - Either currently or previously (in pre-AD condition) literate and capable of<br> reading, writing, and communicating effectively with others;<br><br> - Residence in an assisted living is allowed as is personal assistances provided in<br> the home, however at time of enrollment participant must be able to perform most ADL<br> with minimal assistance, and participant must be permitted sufficient independence<br> to allow assessment of change in ADL;<br><br> - Has a study partner for the duration of the trial who either lives in the same<br> household or interacts with the patient at least 4 hours per day and on at least 4<br> days per week, who is knowledgeable about the patient's daytime and night-time<br> behaviors and who can be available to attend all clinic visits in person at which<br> caregiver assessments are performed.<br><br>Exclusion Criteria:<br><br>Patients will be excluded from the study if 1 or more of the following criteria are<br>applicable:<br><br> - Have any contraindications to MRI scanning, including cardiac<br> pacemaker/defibrillator, ferromagnetic metal implants (e.g., in-skull and cardiac<br> devices other than those approved as safe for use in MRI scanners);<br><br> - Receives considerable help to carry out basic ADL living either in the home or as a<br> resident in a nursing home or similar facility;<br><br> - Lifetime history of a major psychiatric disorder including schizophrenia and bipolar<br> disorder. Major depressive disorder that has resulted in 2 or more hospitalizations<br> in a lifetime. Major depressive episode during the past 5 years that is judged by<br> the clinical team unlikely to have been part of Alzheimer's prodrome. History of<br> suicidality.<br><br> - History of substance abuse within 12 months; use of cannabis or cannabis products<br> within 6 months of consent;<br><br> - Enrolled in another clinical trial where patients receive treatment with an<br> investigational drug or treatment device or have had previous treatment with any<br> investigational medicinal product within 60 days or 5 half-lives (whichever is<br> longer) prior to study drug treatment;<br><br> - A prior organ or stem cell transplant;<br><br> - Seated blood pressure of = 165/105 mmHg at Screening.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)

Secondary Outcome Measures

Name	Time	Method
Change in Clinical Dementia Rating (CDR);Change in apparent fiber density (AFD);Change in Everyday Cognition (E-Cog);Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL);Change in myelin content;Change in non-cognitive behavioral symptoms;Change in gray matter integrity;Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid);Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau);Change in brain structure neurodegeneration;Number of participants who experience adverse events and serious adverse events