Overview
The goal of this Phase 2 Alzheimer's study is to determine whether 1.0 mg/kg XPro1595 confers a benefit on cognition, function, and biomarkers of white matter and to further evaluate safety and tolerability. The objectives of this study are to determine the safety, tolerability, and efficacy of XPro1595 in patients with early ADi.
Description
This trial is a randomized clinical study using XPro1595 to treat patients with Early Alzheimer's Disease with biomarkers of inflammation (ADi). Early ADi patients are defined as patients with Mild Alzheimer's Disease or Mild Cognitive Impairment with a biomarker of inflammation.
Eligibility
Inclusion Criteria:
To be eligible for study entry, patients must satisfy all of the following criteria:
- Adult patients 50 years to ≤ 85 years of age at the time of consent;
- Meets the diagnostic criteria of MCI of probable Alzheimer's disease (Jack et al. 2018; NIAAA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018);
- 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 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.