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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05318976
Registration number
NCT05318976
Ethics application status
Date submitted
7/03/2022
Date registered
8/04/2022
Titles & IDs
Public title
A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
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Scientific title
A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
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Secondary ID [1]
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XPro1595-AD-02
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Universal Trial Number (UTN)
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Trial acronym
MINDFuL
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease
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Dementia
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Brain Diseases
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Central Nervous System Diseases
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Nervous System Diseases
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Tauopathies
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Neurodegenerative Diseases
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Neurocognitive Disorders
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Mental Disorders
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Mild Cognitive Impairment
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Condition category
Condition code
Neurological
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Alzheimer's disease
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Neurological
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Dementias
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Neurological
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Neurodegenerative diseases
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Mental Health
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Other mental health disorders
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Neurological
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Other neurological disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - XPro1595
Treatment: Drugs - Placebo
Experimental: 1.0 mg/kg XPro1595 - 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.
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.
Treatment: Drugs: XPro1595
XPro1595 will be delivered by subcutaneous injection once a week
Treatment: Drugs: Placebo
Placebo will be delivered by subcutaneous injection once a week
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
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Assessment method [1]
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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
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Timepoint [1]
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24 Weeks
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Secondary outcome [1]
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Change in Clinical Dementia Rating (CDR)
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Assessment method [1]
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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
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Timepoint [1]
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24 Weeks
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Secondary outcome [2]
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Change in apparent fiber density (AFD)
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Assessment method [2]
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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
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Timepoint [2]
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24 Weeks
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Secondary outcome [3]
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Change in Everyday Cognition (E-Cog)
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Assessment method [3]
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Change from Baseline to Week 24 in Everyday Cognition (E-Cog)
To evaluate the effect of XPro1595 compared with placebo on E-Cog
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Timepoint [3]
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24 Weeks
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Secondary outcome [4]
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Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-MCI-ADL)
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Assessment method [4]
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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.
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Timepoint [4]
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24 Weeks
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Secondary outcome [5]
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Change in myelin content
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Assessment method [5]
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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.
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Timepoint [5]
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24 Weeks
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Secondary outcome [6]
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Change in non-cognitive behavioral symptoms
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Assessment method [6]
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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
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Timepoint [6]
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24 Weeks
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Secondary outcome [7]
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Change in gray matter integrity
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Assessment method [7]
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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
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Timepoint [7]
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24 Weeks
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Secondary outcome [8]
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Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
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Assessment method [8]
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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).
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Timepoint [8]
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24 Weeks
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Secondary outcome [9]
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Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
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Assessment method [9]
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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)
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Timepoint [9]
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24 Weeks
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Secondary outcome [10]
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Change in brain structure neurodegeneration
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Assessment method [10]
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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
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Timepoint [10]
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24 Weeks
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Secondary outcome [11]
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Number of participants who experience adverse events and serious adverse events
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Assessment method [11]
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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.
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Timepoint [11]
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Baseline up to 28 days post last dose
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Eligibility
Key inclusion criteria
To be eligible for study entry, patients must satisfy all of the following 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.
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Minimum age
50
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Maximum age
85
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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 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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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/04/2025
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Actual
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Sample size
Target
201
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
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Recruitment hospital [1]
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INmune Bio Investigational Site - Darlinghurst
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Recruitment hospital [2]
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INmune Bio Investigational Site - Macquarie Park
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Recruitment hospital [3]
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INmune Bio Investigational Site - Adelaide
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Recruitment hospital [4]
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INmune Bio Investigational Site - Box Hill
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Recruitment hospital [5]
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INmune Bio Investigational Site - Carlton
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Recruitment hospital [6]
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INmune Bio Investigational Site - Ivanhoe
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Recruitment hospital [7]
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INmune Bio Investigational Site - Parkville
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Recruitment hospital [8]
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INmune Bio Investigational Site - Perth
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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2113 - Macquarie Park
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Recruitment postcode(s) [3]
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5011 - Adelaide
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Recruitment postcode(s) [4]
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3128 - Box Hill
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Recruitment postcode(s) [5]
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3053 - Carlton
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Recruitment postcode(s) [6]
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3079 - Ivanhoe
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Recruitment postcode(s) [7]
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3050 - Parkville
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Recruitment postcode(s) [8]
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6009 - Perth
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Recruitment outside Australia
Country [1]
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Canada
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State/province [1]
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Kelowna
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Canada
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State/province [2]
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Ottawa
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Canada
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Sherbrooke
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Canada
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Toronto
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Canada
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State/province [5]
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West Vancouver
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Country [6]
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Czechia
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State/province [6]
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Brno
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Country [7]
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Czechia
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State/province [7]
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Plzen
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Country [8]
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Czechia
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Prague
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Country [9]
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Czechia
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State/province [9]
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Praha
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Czechia
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Rychnov Nad Knežnou
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France
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Nantes
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France
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Toulouse
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Germany
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Berlin
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Germany
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Chemnitz
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Poland
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Bialystok
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Poland
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Bydgoszcz
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Poland
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Wroclaw
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Spain
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Barcelona
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Spain
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Córdoba
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Spain
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Madrid
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Spain
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Valencia
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United Kingdom
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Birmingham
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United Kingdom
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Bristol
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United Kingdom
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Guildford
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United Kingdom
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London
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Country [26]
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United Kingdom
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Motherwell
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Country [27]
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United Kingdom
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Plymouth
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Country [28]
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United Kingdom
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State/province [28]
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Winchester
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Inmune Bio, Inc.
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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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Trial website
https://clinicaltrials.gov/study/NCT05318976
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Trial related presentations / publications
Bongartz T, Sutton AJ, Sweeting MJ, Buchan I, Matteson EL, Montori V. Anti-TNF antibody therapy in rheumatoid arthritis and the risk of serious infections and malignancies: systematic review and meta-analysis of rare harmful effects in randomized controlled trials. JAMA. 2006 May 17;295(19):2275-85. doi: 10.1001/jama.295.19.2275. Erratum In: JAMA. 2006 Jun 7;295(21):2482. Chance SA, Clover L, Cousijn H, Currah L, Pettingill R, Esiri MM. Microanatomical correlates of cognitive ability and decline: normal ageing, MCI, and Alzheimer's disease. Cereb Cortex. 2011 Aug;21(8):1870-8. doi: 10.1093/cercor/bhq264. Epub 2011 Jan 14. Chou RC, Kane M, Ghimire S, Gautam S, Gui J. Treatment for Rheumatoid Arthritis and Risk of Alzheimer's Disease: A Nested Case-Control Analysis. CNS Drugs. 2016 Nov;30(11):1111-1120. doi: 10.1007/s40263-016-0374-z. Clark I, Atwood C, Bowen R, Paz-Filho G, Vissel B. Tumor necrosis factor-induced cerebral insulin resistance in Alzheimer's disease links numerous treatment rationales. Pharmacol Rev. 2012 Oct;64(4):1004-26. doi: 10.1124/pr.112.005850. Epub 2012 Sep 10.
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Public notes
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Contacts
Principal investigator
Name
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Therese Blomberg
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Address
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INmune Bio
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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INmune Bio
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Address
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Country
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Phone
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(858) 964-3720
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05318976