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A Study of XPro1595 in Patients with Early Alzheimer's Disease with Biomarkers of Inflammation

PHASE2ACTIVE_NOT_RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion 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

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.

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Eligibility

Age eligible for study : 50 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2022-02-28

Primary completion: 2025-04-30

Study completion finish: 2025-05-15

Study type

TREATMENT

Phase

PHASE2

Trial ID

NCT05318976

Intervention or treatment

DRUG: XPro1595

DRUG: Placebo

Conditions

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

Condition: Alzheimer Disease, Dementia and more
DRUG: XPro1595 and other drugs
Darlinghurst, New South Wales, Australia and more
Sponsor: Inmune Bio, Inc.

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Find a site

Closest Location:

INmune Bio Investigational Site

Research sites nearby

Select from list below to view details:

INmune Bio Investigational Site
Darlinghurst, New South Wales, Australia
INmune Bio Investigational Site
Macquarie Park, New South Wales, Australia
INmune Bio Investigational Site
Adelaide, South Australia, Australia
INmune Bio Investigational Site
Box Hill, Victoria, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: 1.0 mg/kg XPro1595 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.	DRUG: XPro1595 XPro1595 will be delivered by subcutaneous injection once a week
PLACEBO_COMPARATOR: 1.0 mg/kg Placebo 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.	DRUG: Placebo Placebo will be delivered by subcutaneous injection once a week

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)	Change in the Early and Mild Alzheimer's cognitive composite (EMACC) from Baseline to Week 24 in the following assessments: * International Shopping List Test-Immediate recall (Word List learning Test) * Digit Span Forward and Backward * Category Fluency Test (DKEFS) * Letter Fluency Test (DKEFS) * Trail Making Test Parts A and B * Digit Symbol Coding Test To assess the efficacy of XPro1595 compared with placebo on cognitive performance in patients with early ADi	24 Weeks

Secondary outcome

Secondary Outcome Measure	Secondary Outcome Description	Secondary Outcome Time Frame
Change in Clinical Dementia Rating (CDR)	Change from Baseline to Week 24 in Clinical Dementia Rating Scale (CDR) The CDR scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgement, and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None = 0, Questionable = 0.5, Mild = 1, Moderate = 2, and Severe = 3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment. To assess the effect of XPro1595 compared with placebo on cognition and global function in patients with early ADi	24 Weeks
Change in apparent fiber density (AFD)	Change from Baseline to Week 24 in apparent fiber density (AFD) To assess the efficacy of XPro1595 compared with placebo on axonal integrity in patients with early ADi	24 Weeks
Change in Everyday Cognition (E-Cog)	Change from Baseline to Week 24 in Everyday Cognition (E-Cog) To evaluate the effect of XPro1595 compared with placebo on E-Cog	24 Weeks
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL)	Change from Baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL) To assess the effect of XPro1595 compared with placebo on ADL in patients with early ADi.	24 Weeks
Change in myelin content	Change from Baseline to Week 24 in free-water-corrected tissue Radial diffusivity and 1 of the following i) MRI-specific myelin contrast: ii) a magnetization transfer ratio (MTR) iii) an inhomogeneous magnetization transfer (MT) or iv) an myelin water fraction (MWF) map To assess the efficacy of XPro1595 compared with placebo on myelin in patients with early ADi.	24 Weeks
Change in non-cognitive behavioral symptoms	Change from Baseline to Week 24 in (Neuropsychiatric Inventory \[NPI\] caregiver items) To assess the effect of XPro1595 compared with placebo on noncognitive behavioral symptoms in patients with early ADi	24 Weeks
Change in gray matter integrity	Change from Baseline to Week 24 in Cortical Disarray Measurement (CDM®) To assess the efficacy of XPro1595 compared with placebo on gray matter integrity in patients with early ADi	24 Weeks
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)	Number of participants with a reduction in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration amyloid) from Baseline to Week 24. To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid).	24 Weeks
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)	Change from Baseline to Week 24 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau) To assess the efficacy of XPro1595 compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)	24 Weeks
Change in brain structure neurodegeneration	Changes from Baseline to Week 24 in volumetric magnetic resonance imaging (MRI) To assess the efficacy of XPro1595 compared with placebo on brain structure neurodegeneration	24 Weeks
Number of participants who experience adverse events and serious adverse events	Clinically significant abnormalities of laboratory values, physical findings, electrocardiogram findings and other safety assessments will be recorded as adverse events if the findings meet the defined criteria for adverse events.	Baseline up to 28 days post last dose

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References

Clinical Trials Gov: A Study of XPro1595 in Patients with Early Alzheimer's Disease with Biomarkers of Inflammation