MINDFuL

CompletedPhase 2Results posted

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

A Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Early Alzheimer's Disease With Biomarkers of Inflammation

Lead sponsor

Inmune Bio, Inc.

Asset

XPro1595

Listed sites

Recruiting sites

Enrollment

207

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•Alzheimer's disease•Amyloid biomarker required•Study partner/caregiver required•MRI contraindications excluded

Primary endpoint

•Early and Mild Alzheimer's Cognitive Composite (EMACC)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

NCT IDNCT05318976

Org study IDXPro1595-AD-02

Timeline

Milestones

Study start2022-02-28actual

Study first posted2022-04-08actual

Primary completion2025-05-12actual

Study completion2025-05-12actual

Last update posted2026-06-29actual

Results first posted2026-06-29actual

Assets

Drug assets

XPro1595

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years

Maximum age85 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

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.

Endpoints (10)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Global cognition

Memory

Behavior / neuropsychiatric

Other (unclassified)

Global cognition

4 endpoints

Primary/protocol endpoint

Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)

Time frame:24 Weeks

change from baseline, improvement

Primary/registry result

Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)

Time frame:24 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), z-score	Standard error
1.0 mg/kg XPro1595n=134 Participants	0.05	0.04
1.0 mg/kg Placebon=66 Participants	0.07	0.05

Secondary/protocol endpoint

Change in CDR-SB

Time frame:24 Weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/registry result

Change in CDR-SB

Time frame:24 Weeks

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
1.0 mg/kg XPro1595n=134 Participants	0.21	0.19
1.0 mg/kg Placebon=66 Participants	0.33	0.23

Memory

2 endpoints

Secondary/protocol endpoint

Change in Everyday Cognition (E-Cog)

Time frame:24 Weeks

change from baseline, improvement

Secondary/registry result

Change in Everyday Cognition (E-Cog)

Time frame:24 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
1.0 mg/kg XPro1595n=134 Participants	-0.02	0.10
1.0 mg/kg Placebon=66 Participants	-0.09	0.11

Behavior / neuropsychiatric

2 endpoints

Secondary/protocol endpoint

Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24

Time frame:24 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Secondary/registry result

Change in Neuropsychiatric Inventory (NPI-12) Total Score at Week 24

Time frame:24 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
1.0 mg/kg XPro1595n=134 Participants	-0.40	0.81
1.0 mg/kg Placebon=66 Participants	0.50	0.95

Other (unclassified)

2 endpoints

Other/protocol endpoint/low confidence

Change in Goal Attainment Scale (GAS)

Time frame:24 Weeks

change from baseline, improvement

Other_pre_specified/registry result/low confidence

Change in Goal Attainment Scale (GAS)

Time frame:24 Weeks

change from baseline, improvement

Posted result

Group	Value (least_squares_mean), score on a scale	Standard error
1.0 mg/kg XPro1595n=126 Participants	46.81	1.05
1.0 mg/kg Placebon=64 Participants	45.19	1.46

Publications (4)

Bibliography

Records linked to this trial through ClinicalTrials.gov references, PubMed NCT search, and curated study seeds. 'Canonical' marks design/result papers; others are registry references or candidates.

Registry references + supporting bibliography

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.