NCT03943264 is a Phase 1 clinical trial of XPro1595 in Alzheimer Disease, sponsored by Inmune Bio, Inc..

Who is sponsoring NCT03943264?

NCT03943264 is sponsored by Inmune Bio, Inc..

What drugs are being tested in NCT03943264?

Interventions in NCT03943264: XPro1595.

What condition does NCT03943264 study?

NCT03943264 studies Alzheimer Disease.

Is NCT03943264 still recruiting?

NCT03943264 is currently completed. Last updated 15 June 2023.

Last reviewed 2023-06-15 · How we verify

NCT03943264

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's

Completed Phase 1 Last updated 15 June 2023

What this trial tests

Phase 1 trial testing XPro1595 in Alzheimer Disease in 20 participants. Completed in 1 September 2021.

Timeline

20 November 2019

Primary endpoint
30 June 2021

1 September 2021

Quick facts

Lead sponsor	Inmune Bio, Inc.
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	20
Start date	20 November 2019
Primary completion	30 June 2021
Estimated completion	1 September 2021
Sites	5 locations across Australia

Drugs / interventions tested

XPro1595 — full drug profile →

Conditions studied

Alzheimer Disease — all drugs for Alzheimer Disease →

Sponsor

Inmune Bio, Inc. — full company profile →

Who can join

18 and older, any sex, with Alzheimer Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study is to evaluate safety and target engagement of XPro1595 in Alzheimer's patients with biomarkers of inflammation.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Alzheimer's disease drug development pipeline: 2022.
Cummings J, Lee G, Nahed P, Kambar MEZN, et al · · 2022 · cited 369× · PMID 35516416 · DOI 10.1002/trc2.12295
Alzheimer's disease drug development pipeline: 2020.
Cummings J, Lee G, Ritter A, Sabbagh M, et al · · 2020 · cited 350× · PMID 32695874 · DOI 10.1002/trc2.12050
Alzheimer's disease drug development pipeline: 2021.
Cummings J, Lee G, Zhong K, Fonseca J, et al · · 2021 · cited 312× · PMID 34095440 · DOI 10.1002/trc2.12179
A Path Toward Precision Medicine for Neuroinflammatory Mechanisms in Alzheimer's Disease.
Hampel H, Caraci F, Cuello AC, Caruso G, et al · · 2020 · cited 264× · PMID 32296418 · DOI 10.3389/fimmu.2020.00456
Pathological mechanisms and therapeutic strategies for Alzheimer's disease.
Ju Y, Tam KY. · · 2022 · cited 260× · PMID 34380884 · DOI 10.4103/1673-5374.320970
Reactive astrocytes: The nexus of pathological and clinical hallmarks of Alzheimer's disease.
Price BR, Johnson LA, Norris CM. · · 2021 · cited 134× · PMID 33812051 · DOI 10.1016/j.arr.2021.101335
Glial Cell-Mediated Neuroinflammation in Alzheimer's Disease.
Al-Ghraiybah NF, Wang J, Alkhalifa AE, Roberts AB, et al · · 2022 · cited 127× · PMID 36142483 · DOI 10.3390/ijms231810572
The Link between Oxidative Stress, Mitochondrial Dysfunction and Neuroinflammation in the Pathophysiology of Alzheimer's Disease: Therapeutic Implications and Future Perspectives.
Jurcău MC, Andronie-Cioara FL, Jurcău A, Marcu F, et al · · 2022 · cited 119× · PMID 36358538 · DOI 10.3390/antiox11112167

Verify or expand the search:

Other trials of XPro1595

Trials testing the same drug.

NCT05522387 — An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease · Phase 2 · terminated
NCT05318976 — A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation · Phase 2 · completed

Other recruiting trials for Alzheimer Disease

Currently open trials in the same condition.

NCT07290387 — Tele-Savvy for Latino Caregivers · NA · recruiting
NCT07178210 — Robotic-Enabled Microsurgical Intervention for Neurodegenerative Disease · NA · recruiting
NCT07294885 — Deep Cervical LymphatIc-Venous Anastomosis for Alzheimer's Disease · NA · recruiting
NCT06937229 — A Study to Evaluate the Long-term Efficacy and Safety of KarXT + KarX-EC for Agitation in Alzheimer's Disease (ADAGIO-3) · Phase 3 · recruiting
NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms · NA · recruiting

Other Inmune Bio, Inc. trials

Trials by the same sponsor.

NCT06056791 — Study of INKmune in Patients With mCRPC (CaRe Prostate) · Phase 1, PHASE2 · completed
NCT05522387 — An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease · Phase 2 · terminated
NCT05318976 — A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation · Phase 2 · completed
NCT04370236 — INB03 for the Treatment of Pulmonary Complications From COVID-19 · Phase 2, PHASE3 · terminated
NCT05933070 — A Phase I Open-Label Dose Escalation Study of Intravenous INKmune In Patients With MDS or AML · Phase 1 · terminated

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03943264 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Inmune Bio, Inc.
Last refreshed: 15 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03943264.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing