Study to Assess the Efficacy of XPro™ in Patients With Mild Alzheimer's Disease With Biomarkers of Inflammation

• Status: Recruiting
• Trial end date: 2023-06-19
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to measure cognitive and biological biomarkers in subcutaneously administered XPro™ or placebo in patients with mild ADi.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Inmune Bio, Inc.

Criteria

Inclusion Criteria:

To be eligible for study entry, patients must satisfy all of the following criteria:

• Adult patients ≥ 60 years to ≤ 85 years of age at the time of consent;

• Diagnosed with mild dementia as clinically described in McKhann, (2011) and corresponding to stage 4 of the revised AD staging system (Jack, 2018). Patients who have received previous therapy for Alzheimer's disease may still be eligible;

• Amyloid positive (documented in medical history or assessed during screening through blood test);

• 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 as is personal assistances provided in the home, however at time of enrollment participant must be able to perform most ADL with minimal assistance, and participant must be permitted sufficient independence to allow assessment of change in ADL;

• Has a caregiver willing to serve as a study partner for the duration of the trial who either lives in the same household or interacts with the patient at least 4 hours per day and on at least 4 days per week, who is knowledgeable about the patient's daytime and night-time behaviors and who can be available to attend all clinic visits in person at which caregiver assessments are performed.

Exclusion Criteria:

Patients will be excluded from the study if 1 or more of the following criteria are applicable:

• 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);

• Receives considerable help to carry out basic ADL living either in the home or as a resident in a nursing home or similar facility;

• 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 suicidality. History of substance abuse within 12 months; use of cannabis or cannabis products within 6 months of consent;

• Enrolled in another clinical trial where patients receive treatment with an investigational drug or treatment device or have received treatment on another AD clinical trial within the last 60 days from Day 1;

• A prior organ or stem cell transplant;

• Seated blood pressure of ≥ 165/105 mmHg at Screening.