CompletedNCT05318976MINDFuLUpdated Jun 29, 2026Results posted

A Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

A Phase 2 interventional study of XPro1595 and Placebo in Alzheimer Disease, Dementia and Brain Diseases, sponsored by Inmune Bio, Inc.. Completed at 41 sites in 8 countries. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Inmune Bio, Inc. · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 207
Allocation: Randomized
Ages: 50 Years to 85 Years
Sex: All

Study 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. 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 studied

Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Mild Cognitive Impairment

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Keywords

Inflammation
Biomarker
TNF

In context

Alzheimer Disease

3,965 studies on the registry are indexed under Alzheimer Disease; 926 are open to participants now.

This study's enrollment of 207 is above the median of 70 across 3,019 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Inmune Bio, Inc. is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 50 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

The screening window for this trial is 45 days.

Inclusion criteria

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

Exclusion Criteria:

Patients will be excluded from the study if 1 or more of the following criteria are applicable:

Have any 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 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.

Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 207 participants (actual)

Study arms

Experimental
1.0 mg/kg XPro1595
1.0 mg/kg of XPro1595 will be administered via subcutaneous injection once a week for 23 weeks.
Drug: XPro1595
Placebo comparator
1.0 mg/kg Placebo
1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 23 weeks.
Drug: Placebo

Interventions

DrugXPro1595
XPro1595 will be delivered by subcutaneous injection once a week
Also known as: INB03/XPro™, XENP1595, DN-TNF
DrugPlacebo
Placebo will be delivered by subcutaneous injection once a week
Also known as: Matching Placebo

What researchers measure

Primary outcomes

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.
Time frame: 24 Weeks

Secondary outcomes

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).
Time frame: 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.
Time frame: 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.
Time frame: 24 Weeks

Other outcomes

Change in Goal Attainment Scale (GAS)
Goal Attainment Scaling (GAS): an individualized outcome in which each participant set a minimum of three personalized treatment goals at baseline. Attainment of each goal is rated on a 5-point scale (-2 = much worse than expected; -1 = baseline/somewhat worse; 0 = expected goal level; +1 = somewhat better; +2 = much better than expected). A participant's goal ratings are aggregated across goals into a standardized GAS T-score using the Kiresuk-Sherman formula (which accounts for the number of goals and their inter-correlation), scaled to a mean of 50 and a standard deviation of 10. The reported values are the standardized GAS T-score, not the individual -2 to +2 ratings; a T-score of 50 indicates goals were met on average, and higher T-scores indicate greater goal attainment (better outcome).
Time frame: 24 Weeks

Results

Posted Jun 29, 2026

Participant flow

Participant flow — Overall Study
Milestone	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Started	140	67
Completed	120	62
Not completed	20	5
Withdrew: Adverse event	12	3
Withdrew: Withdrawal by subject	5	2
Withdrew: Protocol violation	1	0
Withdrew: Lost to follow-up	1	0
Withdrew: Never received study drug	1	0

Outcome measures

PrimaryChange 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.

Time frame:: 24 Weeks
Reported as:: Least squares mean · z-score

Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
z-score	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)	0.05 ± 0.04	0.07 ± 0.05

SecondaryChange 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).

Time frame:: 24 Weeks
Reported as:: Least squares mean · score on a scale

Change in CDR-SB
score on a scale	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Change in CDR-SB	0.21 ± 0.19	0.33 ± 0.23

SecondaryChange 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.

Time frame:: 24 Weeks
Reported as:: Least squares mean · score on a scale

Change in Everyday Cognition (E-Cog)
score on a scale	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Change in Everyday Cognition (E-Cog)	-0.02 ± 0.10	-0.09 ± 0.11

SecondaryChange 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.

Time frame:: 24 Weeks
Reported as:: Least squares mean · score on a scale

Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24
score on a scale	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24	-0.40 ± 0.81	0.50 ± 0.95

Other pre-specifiedChange in Goal Attainment Scale (GAS)

Goal Attainment Scaling (GAS): an individualized outcome in which each participant set a minimum of three personalized treatment goals at baseline. Attainment of each goal is rated on a 5-point scale (-2 = much worse than expected; -1 = baseline/somewhat worse; 0 = expected goal level; +1 = somewhat better; +2 = much better than expected). A participant's goal ratings are aggregated across goals into a standardized GAS T-score using the Kiresuk-Sherman formula (which accounts for the number of goals and their inter-correlation), scaled to a mean of 50 and a standard deviation of 10. The reported values are the standardized GAS T-score, not the individual -2 to +2 ratings; a T-score of 50 indicates goals were met on average, and higher T-scores indicate greater goal attainment (better outcome).

Time frame:: 24 Weeks
Reported as:: Least squares mean · score on a scale

Change in Goal Attainment Scale (GAS)
score on a scale	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Change in Goal Attainment Scale (GAS)	46.81 ± 1.05	45.19 ± 1.46

Adverse events

Collected over 24 weeks of treatment plus 4 weeks of safety follow-up (28 weeks total). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
1.0 mg/kg XPro1595	0/139 (0%)	8/139 (5.8%)	131/139 (94.2%)
1.0 mg/kg Placebo	0/67 (0%)	5/67 (7.5%)	59/67 (88.1%)

Most frequent serious events

Showing 10 of 14

Most frequent serious events
Event	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Inguinal herniaGastrointestinal disorders	1/139	1/67
Abdominal painGastrointestinal disorders	0/139	1/67
Intestinal obstructionGastrointestinal disorders	1/139	1/67
Intestinal ischaemiaGastrointestinal disorders	0/139	1/67
BradycardiaCardiac disorders	0/139	1/67
Ventricular fibrillationCardiac disorders	0/139	1/67
Strangulated herniaGeneral disorders	0/139	1/67
Injection site rashGeneral disorders	1/139	0/67
Bile duct stoneHepatobiliary disorders	1/139	0/67
CholelithiasisHepatobiliary disorders	1/139	0/67

Most frequent other events

Showing 10 of 20

Most frequent other events
Event	1.0 mg/kg XPro1595	1.0 mg/kg Placebo
Injection site reactionGeneral disorders	73/139	2/67
Injection site erythemaGeneral disorders	49/139	0/67
Upper respiratory tract infectionInfections and infestations	9/139	11/67
FatigueGeneral disorders	17/139	9/67
ArthralgiaMusculoskeletal and connective tissue disorders	16/139	4/67
HeadacheNervous system disorders	14/139	7/67
DizzinessNervous system disorders	5/139	7/67
Injection site hypersensitivityGeneral disorders	14/139	0/67
Injection site pruritusGeneral disorders	12/139	0/67
DiarrhoeaGastrointestinal disorders	8/139	5/67

Baseline characteristics

Baseline characteristics are reported for the modified Intent-to-Treat (mITT) population: all randomized participants who received ≥1 dose of study drug and had ≥1 post-baseline efficacy assessment. The mITT excludes 1 randomized participant who did not receive study drug and 6 dosed participants without post-baseline efficacy data.

Age, Categorical
Age, Categorical(Participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
<=18 years	0	0	0
Between 18 and 65 years	15	10	25
>=65 years	119	56	175

Age, Continuous
Age, Continuous(years)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
Mean	72.90 ± 6.34	71.89 ± 6.66	72.56 ± 6.45

Sex: Female, Male
Sex: Female, Male(Participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
Female	68	35	103
Male	66	31	97

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
American Indian or Alaska Native	0	0	0
Asian	5	0	5
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	0	0	0
White	126	64	190
More than one race	0	0	0
Unknown or Not Reported	3	2	5

Region of Enrollment
Region of Enrollment(participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
Canada	10	5	15
Czechia	2	0	2
Poland	34	16	50
United Kingdom	60	29	89
Australia	15	10	25
France	3	3	6
Spain	10	3	13

Diagnosis
Diagnosis(Participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
Mild Cognitive Impairment (MCI)	59	31	90
Mild Alzheimer's Dementia (mAD)	75	35	110

Clinical Dementia Rating (CDR) Global Score
Clinical Dementia Rating (CDR) Global Score(Participants)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
0.5	105	56	161
1.0	29	10	39

Clinical Dementia Rating - Sum of Boxes (CDR-SB)
Clinical Dementia Rating - Sum of Boxes (CDR-SB)(units on a scale)	1.0 mg/kg XPro1595	1.0 mg/kg Placebo	Total
Mean	3.23 ± 1.58	2.67 ± 1.345	3.05 ± 1.52

6 further baseline measures are reported on the registry.

Study locations

41 sites

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

References and documents

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 16705109 ↗
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. PubMed 21239393 ↗
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. PubMed 27470609 ↗
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. PubMed 22966039 ↗

Study documents

Protocol and statistical analysis plan ↗ · May 13, 2024

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05318976
Lead sponsor: Inmune Bio, Inc.
Responsible party: Sponsor
First posted: Apr 8, 2022
Start date: Feb 28, 2022
Primary completion: May 12, 2025
Completion: May 12, 2025
Results posted: Jun 29, 2026
Last update: Jun 29, 2026

Study contacts

Therese Blomberg

study director · INmune Bio

Oversight

Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: XENP 1595

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