Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

INmune Bio

Status and phase: Withdrawn; Phase 2

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

Treatments: Drug: XPro1595; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05321498

XPro1595-AD-03

Details and patient eligibility

About

The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.

Full description

This study is designed as a Phase 2, double-blind randomized, placebo-controlled study investigating the safety, tolerability, and efficacy of XPro1595 in patients with MCI. The planned dose is 1.0 mg/kg of XPro1595 and matching placebo.

Sex: All

Ages: 55 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients are eligible to be included in the study only if all the following criteria apply:

• Adult male and female patients ≥ 55 years to ≤ 80 years of age at the time of consent;
• Diagnosed with MCI of probable Alzheimer's disease (Albert 2011; National Institute on Aging - Alzheimer's Association [NIA-AA]). 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);
• Literate and capable of reading, writing, and communicating effectively with others, based on the PI's assessment;
• Has a study partner willing to participate 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 informant assessments are performed.

Exclusion criteria

• 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 at the strength required for this study);
• 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: has answered "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Week 1 Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening;
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

1.0 mg/kg XPro1595

Experimental group

Description:

1.0 mg/kg XPro1595 will be administered via subcutaneous injection once a week for 12 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 12 weeks.

Treatment:

Drug: Placebo