We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 5 for:    inmune bio [Lead]

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05318976
Recruitment Status : Recruiting
First Posted : April 8, 2022
Last Update Posted : August 17, 2022
Sponsor:
Information provided by (Responsible Party):
Inmune Bio, Inc.

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

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Drug: XPro1595 Drug: Placebo Phase 2

Detailed 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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 201 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
  • (2:1) XPro1595 (1mg/kg), placebo
  • Weekly subcutaneous injections
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro™ in Patients With Mild Alzheimer's Disease With Biomarkers of Inflammation.
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : June 19, 2023
Estimated Study Completion Date : June 19, 2023

Resource links provided by the National Library of Medicine


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
Other Names:
  • INB03/XPro™
  • XENP1595
  • DN-TNF

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
Other Name: Matching Placebo




Primary Outcome Measures :
  1. Change in Early and Mild Alzheimer's Cognitive Composite (EMACC) [ Time Frame: 24 Weeks ]

    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 XPro™ compared with placebo on cognitive performance in patients with mild AD



Secondary Outcome Measures :
  1. Change in Clinical Dementia Rating (CDR) [ Time Frame: 24 Weeks ]

    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 XPro™ compared with placebo on cognition and global function in patients with mild AD


  2. Change in apparent fiber density (AFD) [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in apparent fiber density (AFD)

    To assess the efficacy of XPro™ compared with placebo on axonal integrity in patients with mild AD


  3. Change in Everyday Cognition (E-Cog) [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in Everyday Cognition (E-Cog)

    To evaluate the effect of XPro™ compared with placebo on E-Cog


  4. Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)

    To assess the effect of XPro™ compared with placebo on ADL in patients with mild AD.


  5. Change in myelin content [ Time Frame: 24 Weeks ]

    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 XPro™ compared with placebo on myelin in patients with mild AD.


  6. Change in non-cognitive behavioral symptoms [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in (Neuropsychiatric Inventory [NPI] caregiver items)

    To assess the effect of XPro™ compared with placebo on noncognitive behavioral symptoms in patients with mild AD


  7. Change in gray matter integrity [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in Cortical Disarray Measurement (CDM®)

    To assess the efficacy of XPro™ compared with placebo on gray matter integrity in patients with mild AD


  8. Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid) [ Time Frame: 24 Weeks ]

    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 XPro™ compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid).


  9. Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau) [ Time Frame: 24 Weeks ]

    Change from Baseline to Week 24 in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)

    To assess the efficacy of XPro™ compared with placebo on blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)


  10. Change in brain structure neurodegeneration [ Time Frame: 24 Weeks ]

    Changes from Baseline to Week 24 in volumetric magnetic resonance imaging (MRI)

    To assess the efficacy of XPro™ compared with placebo on brain structure neurodegeneration


  11. Number of participants who experience adverse events and serious adverse events [ Time Frame: Baseline up to 28 days post last dose ]
    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.


Other Outcome Measures:
  1. Change in Goal Attainment Scale (GAS) [ Time Frame: 24 Weeks ]

    Change in individual goals based on the Goal Attainment Scale (GAS)

    The achievement of each goal is rated on a 5-point attainment scale (-2, -1, 0, +1, +2) to allow standardized scoring of personalized outcomes. A participant's overall goal attainment is quantified using a formula that takes into account the number of goals that have been set, and the extent to which they are correlated with each other. For each identified goal area, the caregiver will be asked to give a detailed description of the patient's current (baseline) status and goal status, which will be recorded at the -1 and 0 levels on the 5-point scale, respectively. The remaining levels of the scale will then be set: somewhat better than the goal (+1), much better than the goal (+2), and much worse than the goal (-2).

    To evaluate the effect of XPro™ compared with placebo on goal attainment scores




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05318976


Contacts
Layout table for location contacts
Contact: INmune Bio (858)964-3720 trials@inmunebio.com

Locations
Layout table for location information
Australia, New South Wales
INmune Bio Investigational Site Recruiting
Macquarie Park, New South Wales, Australia, 2113
Contact: INmune Bio, Inc.         
Sponsors and Collaborators
Inmune Bio, Inc.
Investigators
Layout table for investigator information
Study Director: Patricia Hopkins INmune Bio
Additional Information:
Publications:
Layout table for additonal information
Responsible Party: Inmune Bio, Inc.
ClinicalTrials.gov Identifier: NCT05318976    
Other Study ID Numbers: XPro-AD-02
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: August 17, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Inmune Bio, Inc.:
Inflammation
Biomarker
TNF
Additional relevant MeSH terms:
Layout table for MeSH terms
Alzheimer Disease
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Tauopathies
Disease
Inflammation
Mental Disorders
Neurocognitive Disorders
Pathologic Processes
Dementia