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A Biomarker-directed Study of XPro1595 in Patients With Alzheimer's
Phase 1b Open-Label, Dose-Identification Study of XPro1595 in Patients With Alzheimer's Disease and Biomarkers of Inflammation.
Lead sponsor
Asset
XPro1595
Listed sites
5
Recruiting sites
-
Enrollment
20
actual
Study population
Alzheimer’s disease
Key I/E criteria
•Alzheimer's disease•Study partner/caregiver required
Primary endpoint
•Treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
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
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Aged 18 years and above at screening;
2. Diagnosed with probable AD defined by the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria;
3. Has hsCRP levels ≥1.5mg/L,OR HbA1c ≥ 6DCCT %, OR Erythrocyte Sedimentation Rate (ESR) ≥10 mm/h, OR APOE4 positive (at least one APOE4 allele);
4. Female of childbearing potential (FCBP) must have confirmed negative urine pregnancy test at Screening;
5. All female of childbearing potential (FCBP) and male patients who are sexually active with a female of childbearing potential must agree to use a highly effective contraception during the treatment period and until 90 days after the last dose of treatment for sexually active males whose partners are FCBP or until 30 days after the last dose of treatment for FCBP.
6. Consents to having lumbar punctures;
7. Consents to apolipoprotein E (APOE) genotyping(if status unknown);
8. Provide written informed consent prior to any study procedures being performed;
9. Has a caregiver who either lives in the same household or interacts withthe patient at least 4 hours per day and at least 4 days per week, who is knowledgeable about the participant's daytime and night-time behaviours and who canbe available to attend all clinic visits in personat which caregiver assessments are performed.Patients with caregivers that do not meet this criterionbut are determined by the investigator as able to provide an adequate assessment of the patient may also participate with prior approval from the sponsor
Exclusion criteria
1. Patients taking cholinesterase inhibitors, memantine, or antidepressant medication for less than 45 days from Day 1 (i.e. must be on stable dose for at least 45 days prior to Day 1);
2. Have taken within the last 45 days from Day 1; corticosteroids or other immunosuppressive drugs, thalidomide or other TNF active drugs, minocycline.
3. Enrolled in another clinical trial where patients receive treatment with investigational drug or device or have received treatment on another AD clinical trial within the last 60 days from Day 1;
4. Unable to tolerate lumbar puncture or taking medicine where lumber punctures are contraindicated (anti-coagulants besides daily 100mg of aspirin);
5. A prior organ or stem cell transplant;
6. A major adverse cardiac event within 6 months before screening;
7. Lymphoma, leukaemia, or any malignancy within the past 5 years with the exception of malignancies with negligible risk of metastasis or death, such as basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ that have been resected with no evidence of metastatic disease for 3 years;
8. Jaundice, active hepatitis, or known hepatobiliary disease (except asymptomatic cholelithiasis);
9. Positive screening assessment for viral hepatitis B surface antigen or hepatitis C virus (HCV) antibody and positive HCV ribonucleic acid or human immunodeficiency virus, or a history of illicit drug injecting;
10. Seated blood pressure of ≥ 165/105 mmHg at screening;
11. Unable to comply with the study procedures and assessments;12.Known hypersensitivity to investigational product or its excipients;
Endpoints (15)
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
1 endpointChange from baseline in the Mini-Mental State Examination (MMSE) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Memory
2 endpointsChange from baseline in the Memory-Enhanced Retrospective Evaluation of Treatment Observer Reported Global Impression of Improvement (MERET OBSRO-C) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Evaluate changes in the Memory-Enhanced Retrospective Evaluation of Change from baseline Global Impression of Improvement (MERET PGI-C) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Executive function / language
2 endpointsChange from baseline in the Digit Symbol Substitution Test (DSST) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Change from baseline in the Verbal Fluency Test following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Function / daily living
1 endpointChange from baseline in the Bristol Activities of Daily Living Scale (BALDS) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Behavior / neuropsychiatric
1 endpointChange from baseline in the Neuropsychiatric Inventory (NPI) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
Neuropsychiatric Inventory (NPI)
change from baseline, improvement
Amyloid biomarkers
1 endpointChanges from baseline in blood and cerebral spinal fluid levels of amyloid beta following 12 weeks of treatment with XPro1595
Time frame:12 weeks
descriptive
Neuroimaging
1 endpointChange from baseline in FreeWater content (edema) using magnetic resonance imaging following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
Safety / tolerability / PK
2 endpointsThe number of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Time frame:12 weeks
event count, event
The percentage of patients with a treatment-emergent adverse event throughout 12 weeks of treatment with XPro1595
Time frame:12 weeks
threshold achievement, event
Other (unclassified)
4 endpointsChanges from baseline in high sensitivity C-reactive protein in the blood and cerebral spinal fluid following 12 weeks of treatment with XPro1595
Time frame:12 weeks
descriptive
Changes from baseline in inflammatory cytokines in the blood and cerebral following 12 weeks of treatment with XPro1595 spinal fluid
Time frame:12 weeks
descriptive
Changes from baseline in cerebral spinal fluid levels of tau following 12 weeks of treatment with XPro1595
Time frame:12 weeks
descriptive
Change from baseline in Breath volatile organic compounds (BVOCs) following 12 weeks of treatment with XPro1595
Time frame:12 weeks
change from baseline, improvement
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
- PMID28237313via RESULT
- PMID22666474via RESULT
- PMID19320056via RESULT
- PMID27552480via RESULT
Provenance
Sources
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.