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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05318976




Registration number
NCT05318976
Ethics application status
Date submitted
7/03/2022
Date registered
8/04/2022
Date last updated
16/05/2024

Titles & IDs
Public title
A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
Scientific title
A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
Secondary ID [1] 0 0
XPro1595-AD-02
Universal Trial Number (UTN)
Trial acronym
MINDFuL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer Disease 0 0
Dementia 0 0
Brain Diseases 0 0
Central Nervous System Diseases 0 0
Nervous System Diseases 0 0
Tauopathies 0 0
Neurodegenerative Diseases 0 0
Neurocognitive Disorders 0 0
Mental Disorders 0 0
Mild Cognitive Impairment 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Neurological 0 0 0 0
Neurodegenerative diseases
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
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
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Timepoint [1] 0 0
24 Weeks
Secondary outcome [1] 0 0
Change in Clinical Dementia Rating (CDR)
Timepoint [1] 0 0
24 Weeks
Secondary outcome [2] 0 0
Change in apparent fiber density (AFD)
Timepoint [2] 0 0
24 Weeks
Secondary outcome [3] 0 0
Change in Everyday Cognition (E-Cog)
Timepoint [3] 0 0
24 Weeks
Secondary outcome [4] 0 0
Change in Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL)
Timepoint [4] 0 0
24 Weeks
Secondary outcome [5] 0 0
Change in myelin content
Timepoint [5] 0 0
24 Weeks
Secondary outcome [6] 0 0
Change in non-cognitive behavioral symptoms
Timepoint [6] 0 0
24 Weeks
Secondary outcome [7] 0 0
Change in gray matter integrity
Timepoint [7] 0 0
24 Weeks
Secondary outcome [8] 0 0
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)
Timepoint [8] 0 0
24 Weeks
Secondary outcome [9] 0 0
Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)
Timepoint [9] 0 0
24 Weeks
Secondary outcome [10] 0 0
Change in brain structure neurodegeneration
Timepoint [10] 0 0
24 Weeks
Secondary outcome [11] 0 0
Number of participants who experience adverse events and serious adverse events
Timepoint [11] 0 0
Baseline up to 28 days post last dose

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; 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.
Minimum age
50 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
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
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
201
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
INmune Bio Investigational Site - Darlinghurst
Recruitment hospital [2] 0 0
INmune Bio Investigational Site - Macquarie Park
Recruitment hospital [3] 0 0
INmune Bio Investigational Site - Adelaide
Recruitment hospital [4] 0 0
INmune Bio Investigational Site - Box Hill
Recruitment hospital [5] 0 0
INmune Bio Investigational Site - Carlton
Recruitment hospital [6] 0 0
INmune Bio Investigational Site - Ivanhoe
Recruitment hospital [7] 0 0
INmune Bio Investigational Site - Parkville
Recruitment hospital [8] 0 0
INmune Bio Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [2] 0 0
2113 - Macquarie Park
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
3128 - Box Hill
Recruitment postcode(s) [5] 0 0
3053 - Carlton
Recruitment postcode(s) [6] 0 0
3079 - Ivanhoe
Recruitment postcode(s) [7] 0 0
3050 - Parkville
Recruitment postcode(s) [8] 0 0
6009 - Perth
Recruitment outside Australia
Country [1] 0 0
Canada
State/province [1] 0 0
Ontario
Country [2] 0 0
Germany
State/province [2] 0 0
Berlin
Country [3] 0 0
Poland
State/province [3] 0 0
Bialystok
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Birmingham
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Bristol
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Guildford
Country [7] 0 0
United Kingdom
State/province [7] 0 0
London
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Motherwell
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Plymouth
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Winchester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Inmune Bio, Inc.
Address
Country

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05318976
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.
Public notes

Contacts
Principal investigator
Name 0 0
Therese Blomberg
Address 0 0
INmune Bio
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
INmune Bio
Address 0 0
Country 0 0
Phone 0 0
(858)964-3720
Fax 0 0
Email 0 0
trials@inmunebio.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05318976