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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2023-10-26

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

* (2:1) XPro1595 (1mg/kg), placebo
* Weekly subcutaneous injections

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1.0 mg/kg XPro1595

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

Group Type EXPERIMENTAL

XPro1595

Intervention Type DRUG

XPro1595 will be delivered by subcutaneous injection once a week.

1.0 mg/kg Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo will be delivered by subcutaneous injection once a week

Interventions

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XPro1595

XPro1595 will be delivered by subcutaneous injection once a week.

Intervention Type DRUG

Placebo

Placebo will be delivered by subcutaneous injection once a week

Intervention Type DRUG

Other Intervention Names

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INB03/XPro™ XENP1595 Dominant-negative Tumor Necrosis Factor (DN-TNF) Matching Placebo

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No