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New drug targets brain inflammation to slow Alzheimer's

NCT ID NCT05318976

Disease control Sponsor: Inmune Bio, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This study tested an experimental drug called XPro1595 in 208 people with early Alzheimer's disease who also had signs of brain inflammation. The goal was to see if the drug could improve memory, thinking, and daily function compared to a placebo over 24 weeks. Researchers also checked for safety and changes in brain health markers.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

207 people

The number who actually took part.

Started

Feb 2022

Finished

May 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

The screening window for this trial is 45 days. 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; 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: 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 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.

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Conditions

The condition(s) this trial relates to.

Alzheimer disease brain disorder central nervous system disorder cognitive disorder Cognitive Dysfunction dementia Inflammation mental disorder nervous system disorder neurodegenerative disease psychiatric disorder tauopathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Alzheimer disease Brain diseases Central nervous system diseases Dementia Mental disorders Mild cognitive impairment Nervous system diseases Neurocognitive disorders Neurodegenerative diseases Tauopathies

Contacts and locations

Locations

  • INmune Bio Investigational Site

    Darlinghurst, New South Wales, 2010, Australia

  • INmune Bio Investigational Site

    Macquarie Park, New South Wales, 2113, Australia

  • INmune Bio Investigational Site

    Adelaide, South Australia, 5011, Australia

  • INmune Bio Investigational Site

    Box Hill, Victoria, 3128, Australia

  • INmune Bio Investigational Site

    Carlton, Victoria, 3053, Australia

  • INmune Bio Investigational Site

    Ivanhoe, Victoria, 3079, Australia

  • INmune Bio Investigational Site

    Parkville, Victoria, 3050, Australia

  • INmune Bio Investigational Site

    Nedlands, Western Australia, 6009, Australia

  • INmune Bio Investigational Site

    Kelowna, V1Y 1Z9, Canada

  • INmune Bio Investigational Site

    Ottawa, K1Z 1G3, Canada

  • INmune Bio Investigational Site

    Sherbrooke, J1L 0H8, Canada

  • INmune Bio Investigational Site

    Toronto, M3B 2S7, Canada

  • INmune Bio Investigational Site

    Toronto, M4G 3E8, Canada

  • INmune Bio Investigational Site

    West Vancouver, V7T 1C5, Canada

  • INmune Bio Investigational Site

    Brno, 60200, Czechia

  • INmune Bio Investigational Site

    Pilsen, 30100, Czechia

  • INmune Bio Investigational Site

    Prague, 10000, Czechia

  • INmune Bio Investigational Site

    Prague, 16000, Czechia

  • INmune Bio Investigational Site

    Rychnov nad Kněžnou, 51601, Czechia

  • INmune Bio Investigational Site

    Bron, 69500, France

  • INmune Bio Investigational Site

    Nantes, 44800, France

  • INmune Bio Investigational Site

    Toulouse, 31059, France

  • INmune Bio Investigational Site

    Berlin, 10629, Germany

  • INmune Bio Investigational Site

    Chemnitz, 09111, Germany

  • INmune Bio Investigational Site

    Bialystok, 15-756, Poland

  • INmune Bio Investigational Site

    Bydgoszcz, 85-133, Poland

  • INmune Bio Investigational Site

    Wroclaw, 53-659, Poland

  • INmune Bio Investigational Site

    Barcelona, 08028, Spain

  • INmune Bio Investigational Site

    Barcelona, 08222, Spain

  • INmune Bio Investigational Site

    Córdoba, 14004, Spain

  • INmune Bio Investigational Site

    Madrid, 28006, Spain

  • INmune Bio Investigational Site

    Seville, 41009, Spain

  • INmune Bio Investigational Site

    Valencia, 46017, Spain

  • INmune Bio Investigational Site

    Valencia, 46026, Spain

  • INmune Bio Investigational Site

    Birmingham, B16 8LT, United Kingdom

  • INmune Bio Investigational Site

    Bristol, BS32 4SY, United Kingdom

  • INmune Bio Investigational Site

    Guildford, GU2 7YD, United Kingdom

  • INmune Bio Investigational Site

    London, W1G 9JF, United Kingdom

  • INmune Bio Investigational Site

    Motherwell, ML1 4UF, United Kingdom

  • INmune Bio Investigational Site

    Plymouth, PL7 8BT, United Kingdom

  • INmune Bio Investigational Site

    Winchester, S021 1HU, United Kingdom

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