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NCT05522387
An Open-Label Extension of XPro1595 in Patients With Alzheimer's Disease
Terminated
Phase 2
Last updated 27 February 2026
What this trial tests
Phase 2 trial testing XPro1595 in Alzheimer Disease in 11 participants. Terminated before completion.
Timeline
21 February 2023
Primary endpoint
5 June 2024
5 June 2024
5 July 2024
Quick facts
| Lead sponsor | Inmune Bio, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 11 |
| Start date | 21 February 2023 |
| Primary completion | 5 June 2024 |
| Estimated completion | 5 July 2024 |
| Sites | 4 locations across Australia |
Drugs / interventions tested
- XPro1595 — full drug profile →
Conditions studied
- Alzheimer Disease — all drugs for Alzheimer Disease →
- Dementia — all drugs for Dementia →
- Brain Diseases — all drugs for Brain Diseases →
- Central Nervous System Diseases — all drugs for Central Nervous System Diseases →
Sponsor
Inmune Bio, Inc. — full company profile →
Who can join
Adults 55 to 86, any sex, with Alzheimer Disease or Dementia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The goal of this Phase 2 Open Label study is to evaluate long-term safety, tolerability, and efficacy of XPro1595 on measures of cognition, function and brain quality in individuals with Alzheimer's Disease.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Alzheimer's disease drug development pipeline: 2023.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2023 · cited 326× · PMID 37251912 · DOI 10.1002/trc2.12385 -
Alzheimer's disease drug development pipeline: 2024.
Cummings J, Zhou Y, Lee G, Zhong K, et al · · 2024 · cited 209× · PMID 38659717 · DOI 10.1002/trc2.12465 -
Molecular Mechanisms of Neuroinflammation in Aging and Alzheimer's Disease Progression.
Andronie-Cioara FL, Ardelean AI, Nistor-Cseppento CD, Jurcau A, et al · · 2023 · cited 109× · PMID 36768235 · DOI 10.3390/ijms24031869 -
Targeting Microglia in Alzheimer's Disease: Pathogenesis and Potential Therapeutic Strategies.
Sun Z, Zhang X, So KF, Jiang W, et al · · 2024 · cited 32× · PMID 39062547 · DOI 10.3390/biom14070833 -
Recent Advances in Therapeutics for the Treatment of Alzheimer's Disease.
Thawabteh AM, Ghanem AW, AbuMadi S, Thaher D, et al · · 2024 · cited 26× · PMID 39519769 · DOI 10.3390/molecules29215131 -
Modeling the neuroimmune system in Alzheimer's and Parkinson's diseases.
Balestri W, Sharma R, da Silva VA, Bobotis BC, et al · · 2024 · cited 26× · PMID 38263227 · DOI 10.1186/s12974-024-03024-8 -
Biomarkers and therapeutic strategies targeting microglia in neurodegenerative diseases: current status and future directions.
Noh MY, Kwon HS, Kwon MS, Nahm M, et al · · 2025 · cited 24× · PMID 40640892 · DOI 10.1186/s13024-025-00867-4 -
Immune modulation to treat Alzheimer's disease.
Duggan MR, Morgan DG, Price BR, Rajbanshi B, et al · · 2025 · cited 18× · PMID 40165251 · DOI 10.1186/s13024-025-00828-x
Verify or expand the search:
- PubMed search for NCT05522387
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of XPro1595
Trials testing the same drug.
- NCT05318976 — A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation · Phase 2 · completed
- NCT03943264 — A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's · Phase 1 · completed
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Currently open trials in the same condition.
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- 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
- 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
- NCT03943264 — A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's · Phase 1 · completed
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 NCT05522387 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 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: 27 February 2026
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/NCT05522387.
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