Study to Assess the Efficacy of XPro™ in Patients With Mild Alzheimer's Disease With Biomarkers of Inflammation (MINDFuL)

  • STATUS
    Recruiting
  • End date
    Jun 19, 2023
  • participants needed
    201
  • sponsor
    Inmune Bio, Inc.
Updated on 4 October 2022
dementia
alzheimer's disease
amyloid
mild dementia
cognitive assessment

Summary

The purpose of this study is to measure cognitive and biological biomarkers in subcutaneously administered XPro™ or placebo in patients with mild ADi.

Description

This study is designed as a double-blind randomized, placebo-controlled, study investigating the safety, tolerability, and efficacy of XPro™ in patients with mild AD with inflammation (ADi). The planned dose is 1.0 mg/kg of XPro™ and matching placebo.

Details
Condition Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders, Mental Disorders
Treatment Placebo, XPro1595
Clinical Study IdentifierNCT05318976
SponsorInmune Bio, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

To be eligible for study entry, patients must satisfy all of the following
criteria
Adult patients ≥ 60 years to ≤ 85 years of age at the time of consent
Diagnosed with mild dementia as clinically described in McKhann, (2011) and corresponding to stage 4 of the revised AD staging system (Jack, 2018). 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)
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 caregiver willing to serve as 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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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