Alzheimer DiseasePhase 2MINDFuLNCT05318976
A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
A Phase 2 study testing XPro1595 in people with Alzheimer Disease and Dementia, run by Inmune Bio, Inc. at 41 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, Dementia, Brain Diseases
- What is being tested?
- XPro1595
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 207 participants
- Where
- 41 sitesin 8 countries
- Study dates
- 28 Feb 2022to 12 May 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
41 sites in 8 countries.
41 sites in 8 countries
Australia8 sites
INmune Bio Investigational Site
Adelaide, South Australia, 5011
INmune Bio Investigational Site
Box Hill, Victoria, 3128
INmune Bio Investigational Site
Carlton, Victoria, 3053
INmune Bio Investigational Site
Darlinghurst, New South Wales, 2010
INmune Bio Investigational Site
Ivanhoe, Victoria, 3079
INmune Bio Investigational Site
Macquarie Park, New South Wales, 2113
INmune Bio Investigational Site
Nedlands, Western Australia, 6009
INmune Bio Investigational Site
Parkville, Victoria, 3050
Spain7 sites
INmune Bio Investigational Site
Barcelona, 08028
INmune Bio Investigational Site
Barcelona, 08222
INmune Bio Investigational Site
Córdoba, 14004
INmune Bio Investigational Site
Madrid, 28006
INmune Bio Investigational Site
Seville, 41009
INmune Bio Investigational Site
Valencia, 46017
INmune Bio Investigational Site
Valencia, 46026
United Kingdom7 sites
INmune Bio Investigational Site
Birmingham, B16 8LT
INmune Bio Investigational Site
Bristol, BS32 4SY
INmune Bio Investigational Site
Guildford, GU2 7YD
INmune Bio Investigational Site
London, W1G 9JF
INmune Bio Investigational Site
Motherwell, ML1 4UF
INmune Bio Investigational Site
Plymouth, PL7 8BT
INmune Bio Investigational Site
Winchester, S021 1HU
Canada6 sites
INmune Bio Investigational Site
Kelowna, V1Y 1Z9
INmune Bio Investigational Site
Ottawa, K1Z 1G3
INmune Bio Investigational Site
Sherbrooke, J1L 0H8
INmune Bio Investigational Site
Toronto, M3B 2S7
INmune Bio Investigational Site
Toronto, M4G 3E8
INmune Bio Investigational Site
West Vancouver, V7T 1C5
Czechia5 sites
INmune Bio Investigational Site
Brno, 60200
INmune Bio Investigational Site
Pilsen, 30100
INmune Bio Investigational Site
Prague, 10000
INmune Bio Investigational Site
Prague, 16000
INmune Bio Investigational Site
Rychnov nad Kněžnou, 51601
France3 sites
INmune Bio Investigational Site
Bron, 69500
INmune Bio Investigational Site
Nantes, 44800
INmune Bio Investigational Site
Toulouse, 31059
Poland3 sites
INmune Bio Investigational Site
Bialystok, 15-756
INmune Bio Investigational Site
Bydgoszcz, 85-133
INmune Bio Investigational Site
Wroclaw, 53-659
Germany2 sites
INmune Bio Investigational Site
Berlin, 10629
INmune Bio Investigational Site
Chemnitz, 09111
About this study
Official title: A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
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.
Read the detailed description
This trial is a randomized clinical study using XPro1595 to treat patients with Early Alzheimer's Disease with biomarkers of inflammation (ADi). Early ADi patients are defined as patients with Mild Alzheimer's Disease or Mild Cognitive Impairment (MCI) with a biomarker of inflammation.
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
- Being tested
- XPro1595, Placebo
- Keywords
- Inflammation, Biomarker, TNF
- Medical subject headings
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XPro1595Drug
Also called INB03/XPro™, XENP1595, DN-TNF
XPro1595 will be delivered by subcutaneous injection once a week
PlaceboDrug
Also called Matching Placebo
Placebo will be delivered by subcutaneous injection once a week
| Study group | Role | What they receive |
|---|---|---|
| 1.0 mg/kg XPro1595 | Experimental | 1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. Receives: Drug: XPro1595 |
| 1.0 mg/kg Placebo | Placebo comparator | 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency [D-KEFS]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement.
Measured: 24 Weeks
Secondary outcomes (3)
Change in CDR-SB
Change from Baseline to Week 24 in the Clinical Dementia Rating - Sum of Boxes (CDR-SB), the sum of the six CDR domain box scores (each 0, 0.5, 1, 2, or 3); total range 0 to 18, with higher scores indicating greater impairment (worse outcome). A negative change favors XPro1595 (less decline).
Measured: 24 Weeks
Change in Everyday Cognition (E-Cog)
Change from Baseline to Week 24 in the Everyday Cognition (E-Cog) total score, a 39-item informant-report questionnaire that asks the study partner to rate the participant's current performance on cognitively relevant everyday activities relative to 10 years prior (i.e., before illness onset). Activities span memory, language, visuospatial/perceptual abilities, planning, organization, and divided attention. Each item is rated on a 4-point scale from 1 (better or no change) to 4 (consistently much worse). The total score is the mean of all rated items and ranges from 1 to 4, with higher scores indicating greater decline since prior to illness onset.
Measured: 24 Weeks
Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24
Change from Baseline to Week 24 in the Neuropsychiatric Inventory, 12-domain version (NPI-12), a structured interview administered to the study partner (informant) assessing 12 neuropsychiatric domains (delusions; hallucinations; agitation/aggression; depression/dysphoria; anxiety; elation/euphoria; apathy/indifference; disinhibition; irritability/lability; aberrant motor behavior; nighttime behaviors; appetite/eating). Each domain is scored as frequency (1-4) × severity (1-3); the total score is the sum of domain scores and ranges from 0 to 144.
Higher scores indicate greater neuropsychiatric burden (worse outcome); a negative change from baseline favors XPro1595. The total score is reported; domain or subfactor scores, where applicable, are interpreted only within the context of the full instrument.
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2022
- Study start28 Feb 2022
- Primary completion12 May 2025
- Study completion12 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- * (2:1) XPro1595 (1mg/kg), placebo * Weekly subcutaneous injections
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inmune Bio, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Therese Blomberg, Study director, INmune Bio
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05318976
- Sponsor's protocol ID
- XPro1595-AD-02
- Acronym
- MINDFuL
- Status last verified
- Apr 2026
- First submitted
- 7 Mar 2022
- Last updated
- 29 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 16705109Chance 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.
PubMed 21239393Chou 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.
PubMed 27470609Clark 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.
PubMed 22966039
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation
- ClinicalTrials.gov ID
- NCT05318976
- Acronym / sponsor ID
- MINDFuL / XPro1595-AD-02
- Conditions
- Alzheimer Disease, Dementia, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies
- Keywords
- Inflammation, Biomarker, TNF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Inmune Bio, Inc.Industry (pharma, biotech, devices)
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 12 May 2025 (actual)
- First posted
- 8 Apr 2022 (actual)
- Results
- Posted 29 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This trial is a randomized clinical study using XPro1595 to treat patients with Early Alzheimer's Disease with biomarkers of inflammation (ADi). Early ADi patients are defined as patients with Mild Alzheimer's Disease or Mild Cognitive Impairment (MCI) with a biomarker of inflammation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- * (2:1) XPro1595 (1mg/kg), placebo * Weekly subcutaneous injections
| Arm | Type | Receives |
|---|---|---|
| 1.0 mg/kg XPro1595 | Experimental | Drug: XPro15951.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks. |
| 1.0 mg/kg Placebo | Placebo comparator | Drug: Placebo1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| XPro1595Also: INB03/XPro™, XENP1595, DN-TNFXPro1595 will be delivered by subcutaneous injection once a week | Drug | 1.0 mg/kg XPro1595 |
| PlaceboAlso: Matching PlaceboPlacebo will be delivered by subcutaneous injection once a week | Drug | 1.0 mg/kg Placebo |
Primary outcome
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
Time frame: 24 Weeks
Change from Baseline to Week 24 in the Early and Mild Alzheimer's Cognitive Composite (EMACC), a z-score composite of six neuropsychological tests (International Shopping List Test-Immediate Recall; Digit Span Forward/Backward; Category Fluency; Letter Fluency [D-KEFS]; Trail Making Test A and B; Digit Symbol Coding). Each component is standardized to the pooled baseline mean (0) and SD (1), then averaged. Higher scores indicate better cognitive performance; a positive change from baseline indicates improvement.
3 secondary outcomes
Change in CDR-SB
Time frame: 24 Weeks
Change in Everyday Cognition (E-Cog)
Time frame: 24 Weeks
Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24
Time frame: 24 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 16705109Bongartz 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.
- Background: PubMed 21239393Chance 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.
- Background: PubMed 27470609Chou 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.
- Background: PubMed 22966039Clark 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.
- Alzheimer's Association annual report releasing statistics regarding Alzheimer's diseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Therese Blomberg study director
INmune Bio
41 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing XPro1595 in people with Alzheimer Disease and Dementia, run by Inmune Bio, Inc. at 41 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Australia, Spain, United Kingdom, Canada, Czechia and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC) (time frame: 24 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05318976, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2026.