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

Inmune Bio, Inc.

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

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

Interventions

XPro1595DRUG

XPro1595 will be delivered by subcutaneous injection once a week.

PlaceboDRUG

Placebo will be delivered by subcutaneous injection once a week

Eligibility

Sex: ALLMin age: 55 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Change from Baseline to Week 12 in the Early and Mild Alzheimer's Cognitive Composite (EMACC) (Jaeger 2017) made up of the following tests: * International Shopping List Test- Immediate recall (Word List Learning Test-Immediate recall) * Trail Making Test Part A and B * Digit Symbol Coding Test * Digit Span Forward and Backward * Category Fluency Test (DKEFS) * Letter Fluency Test (DKEFS) To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI

Time frame: 12 Weeks

Secondary Outcomes

Change in Mean Computer-based Cognitive Assessment (Cogstate) Composite score from Screening to Week 12

Change from Screening to Week 12 in Cogstate Composite mean score. Cogstate is a brief, computerized, neuropsychological battery to evaluate cognitive impairments in mild cognitive impairment (MCI), and Alzheimer's disease (AD). CogState assesses attention and memory functions - including Information processing speed, Visual attention, Working memory and Visual learning. Cogstate scores are measured on a linear scale (with no maximum score). A reduction in scores compared to baseline signifies an improvement in cognitive functions. The Cogstate battery will be administered at Screening and each week for 12 weeks. To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with MCI

Time frame: 12 Weeks

Change in myelin content

Change from Screening to Week 12 in myelin content.

Time frame: 12 Weeks

Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)

Change from Screening to Week 12 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid) To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)

Data from ClinicalTrials.gov

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