A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
NCT ID: NCT05318976
Last Updated: 2025-08-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
208 participants
INTERVENTIONAL
2022-02-28
2025-05-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
* Weekly subcutaneous injections
TREATMENT
QUADRUPLE
Study Groups
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1.0 mg/kg XPro1595
1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.
XPro1595
XPro1595 will be delivered by subcutaneous injection once a week
1.0 mg/kg Placebo
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.
Placebo
Placebo will be delivered by subcutaneous injection once a week
Interventions
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XPro1595
XPro1595 will be delivered by subcutaneous injection once a week
Placebo
Placebo will be delivered by subcutaneous injection once a week
Other Intervention Names
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Eligibility Criteria
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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.
50 Years
85 Years
ALL
No
Sponsors
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Inmune Bio, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Therese Blomberg
Role: STUDY_DIRECTOR
INmune Bio
Locations
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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
INmune Bio Investigational Site
Carlton, Victoria, Australia
INmune Bio Investigational Site
Ivanhoe, Victoria, Australia
INmune Bio Investigational Site
Parkville, Victoria, Australia
INmune Bio Investigational Site
Nedlands, Western Australia, Australia
INmune Bio Investigational Site
Kelowna, , Canada
INmune Bio Investigational Site
Ottawa, , Canada
INmune Bio Investigational Site
Sherbrooke, , Canada
INmune Bio Investigational Site
Toronto, , Canada
INmune Bio Investigational Site
Toronto, , Canada
INmune Bio Investigational Site
West Vancouver, , Canada
INmune Bio Investigational Site
Brno, , Czechia
INmune Bio Investigational Site
Pilsen, , Czechia
INmune Bio Investigational Site
Prague, , Czechia
INmune Bio Investigational Site
Prague, , Czechia
INmune Bio Investigational Site
Rychnov nad Kněžnou, , Czechia
INmune Bio Investigational Site
Bron, , France
INmune Bio Investigational Site
Nantes, , France
INmune Bio Investigational Site
Toulouse, , France
INmune Bio Investigational Site
Berlin, , Germany
INmune Bio Investigational Site
Chemnitz, , Germany
INmune Bio Investigational Site
Bialystok, , Poland
INmune Bio Investigational Site
Bydgoszcz, , Poland
INmune Bio Investigational Site
Wroclaw, , Poland
INmune Bio Investigational Site
Barcelona, , Spain
INmune Bio Investigational Site
Barcelona, , Spain
INmune Bio Investigational Site
Córdoba, , Spain
INmune Bio Investigational Site
Madrid, , Spain
INmune Bio Investigational Site
Seville, , Spain
INmune Bio Investigational Site
Valencia, , Spain
INmune Bio Investigational Site
Valencia, , Spain
INmune Bio Investigational Site
Birmingham, , United Kingdom
INmune Bio Investigational Site
Bristol, , United Kingdom
INmune Bio Investigational Site
Guildford, , United Kingdom
INmune Bio Investigational Site
London, , United Kingdom
INmune Bio Investigational Site
Motherwell, , United Kingdom
INmune Bio Investigational Site
Plymouth, , United Kingdom
INmune Bio Investigational Site
Winchester, , United Kingdom
Countries
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References
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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.
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.
Related Links
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Alzheimer's Association annual report releasing statistics regarding Alzheimer's disease
Other Identifiers
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XPro1595-AD-02
Identifier Type: -
Identifier Source: org_study_id
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