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A Study of XPro1595 in Patients With Early 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 : May 16, 2024
Sponsor:
Information provided by (Responsible Party):
Inmune Bio, Inc.

Study Description
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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.

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 Mild Cognitive Impairment Drug: XPro1595 Drug: Placebo Phase 2

Detailed Description:
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 with a biomarker of inflammation.
Study Design
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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 Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
Actual Study Start Date : February 28, 2022
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 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 XPro1595 compared with placebo on goal attainment scores



Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   50 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 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; NIAAA) or mild dementia as clinically described in McKhann, (2011) and corresponding to stages 3 or 4 of the revised AD staging system (Jack, 2018);
  • 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:

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.
Contacts and Locations
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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
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Contact: INmune Bio (858)964-3720 trials@inmunebio.com

Locations
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Australia, New South Wales
INmune Bio Investigational Site Completed
Darlinghurst, New South Wales, Australia, 2010
INmune Bio Investigational Site Recruiting
Macquarie Park, New South Wales, Australia, 2113
Contact: INmune Bio, Inc.         
Australia, South Australia
INmune Bio Investigational Site Recruiting
Adelaide, South Australia, Australia, 5011
Contact: INmune Bio, Inc.         
Australia, Victoria
INmune Bio Investigational Site Completed
Box Hill, Victoria, Australia, 3128
INmune Bio Investigational Site Completed
Carlton, Victoria, Australia, 3053
INmune Bio Investigational Site Recruiting
Ivanhoe, Victoria, Australia, 3079
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Completed
Parkville, Victoria, Australia, 3050
Australia, Western Australia
INmune Bio Investigational Site Recruiting
Perth, Western Australia, Australia, 6009
Contact: INmune Bio, Inc.         
Canada, Ontario
INmune Bio Investigational Site Not yet recruiting
Ottawa, Ontario, Canada, K1Z 1G3
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Not yet recruiting
Toronto, Ontario, Canada, M4G 3E8
Contact: INmune Bio, Inc.         
Germany
INmune Bio Investigational Site Recruiting
Berlin, Germany, 10629
Contact: INmune Bio, Inc         
Poland
INmune Bio Investigational Site Recruiting
Białystok, Poland, 15-756
Contact: INmune Bio, Inc         
United Kingdom
INmune Bio Investigational Site Recruiting
Birmingham, United Kingdom, B16 8LT
Contact: INmune Bio, Inc         
INmune Bio Investigational Site Recruiting
Bristol, United Kingdom, BS32 4SY
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Recruiting
Guildford, United Kingdom, GU2 7YD
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Recruiting
London, United Kingdom, W1G 9JF
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Recruiting
Motherwell, United Kingdom, ML1 4UF
Contact: INmune Bio, Inc         
INmune Bio Investigational Site Recruiting
Plymouth, United Kingdom, PL7 8BT
Contact: INmune Bio, Inc.         
INmune Bio Investigational Site Recruiting
Winchester, United Kingdom, S021 1HU
Contact: INmune Bio, Inc.         
Sponsors and Collaborators
Inmune Bio, Inc.
Investigators
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Study Director: Therese Blomberg INmune Bio
More Information
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Additional Information:

Publications:

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Responsible Party: Inmune Bio, Inc.
ClinicalTrials.gov Identifier: NCT05318976    
Other Study ID Numbers: XPro1595-AD-02
First Posted: April 8, 2022    Key Record Dates
Last Update Posted: May 16, 2024
Last Verified: May 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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:
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Alzheimer Disease
Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Central Nervous System Diseases
Tauopathies
Inflammation
 Cognitive Dysfunction
Mental Disorders
Neurocognitive Disorders
Pathologic Processes
Dementia
Cognition Disorders