WithdrawnPhase 2

Study to Assess the Efficacy of XPro1595 in Patients With Mild Cognitive Impairment With Biomarkers of Inflammation

A Phase 2, Randomized, Placebo-Controlled, Double-Blind Study of XPro1595 in Patients With Mild Cognitive Impairment (MCI) With Biomarkers of Inflammation

Lead sponsor

Inmune Bio, Inc.

Asset

XPro1595

Listed sites

Recruiting sites

Enrollment

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)

Identifiers

Registered as

NCT IDNCT05321498

Org study IDXPro1595-AD-03

Timeline

Milestones

Study first posted2022-04-11actual

Study start2023-06estimated (month precision)

Last update posted2023-09-28actual

Primary completion2023-10-26estimated

Study completion2023-10-26estimated

Assets

Drug assets

XPro1595

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age55 Years

Maximum age80 Years

SexAll

Healthy volunteersNot accepted

Inclusion criteria

Patients are eligible to be included in the study only if all the following criteria apply:

•Adult male and female patients ≥ 55 years to ≤ 80 years of age at the time of consent;

•Diagnosed with MCI of probable Alzheimer's disease (Albert 2011; National Institute on Aging - Alzheimer's Association [NIA-AA]). Patients who have received previous therapy for Alzheimer's disease may still be eligible;

•Amyloid positive (documented in medical history or assessed during screening through blood test);

•Literate and capable of reading, writing, and communicating effectively with others, based on the PI's assessment;

•Has a study partner willing to participate 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 informant assessments are performed

Exclusion criteria

•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 at the strength required for this study);

•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: has answered "yes" to Columbia-Suicide Severity Rating Scale (C-SSRS) suicidal ideation items 4 or 5, or any suicidal behavior within 6 months before Screening, at Screening, or at the Week 1 Visit, or has been hospitalized or treated for suicidal behavior in the past 5 years before Screening;

•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 received treatment on another AD clinical trial within the last 60 days from Day 1

Endpoints (17)

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

Neuroimaging

Other (unclassified)

Executive function / language

Function / daily living

Behavior / neuropsychiatric

Amyloid biomarkers

Tau biomarkers

Fluid / digital biomarkers

Caregiver / quality of life

Safety / tolerability / PK

Other clinical outcomes

Global cognition

3 endpoints

Primary/protocol endpoint

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

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Mean Computer-based Cognitive Assessment (Cogstate) Composite score from Screening to Week 12

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in Clinical Dementia Rating Scale Sum of Boxes (CDR-SB)

Time frame:12 Weeks

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

change from baseline, improvement

Executive function / language

1 endpoint

Secondary/protocol endpoint

Change in speech and language

Time frame:12 Weeks

change from baseline, improvement

Function / daily living

1 endpoint

Secondary/protocol endpoint

Change in Alzheimer's Disease Cooperative Study - Mild Cognitive Impairment Activities of Daily Living (ADCS-MCI ADL)

Time frame:12 Weeks

ADCS-Activities of Daily Living (ADCS-ADL)

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint

Secondary/protocol endpoint

Change in non-cognitive behavioral symptoms

Time frame:12 Weeks

Neuropsychiatric Inventory (NPI)

change from baseline, improvement

Amyloid biomarkers

1 endpoint

Secondary/protocol endpoint

Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker amyloid)

Time frame:12 Weeks

change from baseline, improvement

Tau biomarkers

1 endpoint

Secondary/protocol endpoint

Change in blood inflammatory and neurodegeneration biomarkers (on blood inflammatory and neurodegeneration biomarker pTau)

Time frame:12 Weeks

change from baseline, improvement

Neuroimaging

3 endpoints

Secondary/protocol endpoint

Change in Imaging (MRI) Neuroinflammation

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in imaging markers of brain quality

Time frame:12 Weeks

change from baseline, improvement

Secondary/protocol endpoint

Change in apparent fiber density (AFD)

Time frame:12 Weeks

change from baseline, improvement

Fluid / digital biomarkers

1 endpoint

Secondary/protocol endpoint

Change in brain activity

Time frame:12 Weeks

change from baseline, improvement

Caregiver / quality of life

1 endpoint

Other/protocol endpoint

Change in Goal Attainment Scale (GAS)

Time frame:12 Weeks

change from baseline, improvement

Safety / tolerability / PK

1 endpoint

Secondary/protocol endpoint

Number of participants who experience adverse events and serious adverse events

Time frame:Screening up to 28 days post last dose

event count, event

Other clinical outcomes

1 endpoint

Other/protocol endpoint

Change in measures of activity

Time frame:12 Weeks

change from baseline, improvement

Other (unclassified)

2 endpoints

Secondary/protocol endpoint/low confidence

Change in myelin content

Time frame:12 Weeks

change from baseline, improvement

Other/protocol endpoint/low confidence

Evaluate predictability of patient response after placebo administration and potential influence of study partners on outcome evaluation using the Multidimensional Psychological Questionnaire (MPsQ) with a 5 point scale

Time frame:12 Weeks

ratio, descriptive

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 tableno registry results posted yet

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.