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

INmune Bio

Status and phase: Enrolling; Phase 2

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

Treatments: Drug: XPro1595; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05318976

XPro1595-AD-02

Details and patient eligibility

About

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.

Full 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 (MCI) with a biomarker of inflammation.

Enrollment: 201 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

The screening window for this trial is 45 days.

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; 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);
• 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 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 had previous treatment with any investigational medicinal product within 60 days or 5 half-lives (whichever is longer) prior to study drug treatment;
• A prior organ or stem cell transplant;
• Seated blood pressure of ≥ 165/105 mmHg at Screening.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups, including a placebo group

1.0 mg/kg XPro1595

Experimental group

Description:

1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.

Treatment:

Drug: XPro1595

1.0 mg/kg Placebo

Placebo Comparator group

Description:

1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.

Treatment:

Drug: Placebo