Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): MCI patients will now be enrolled in the XPro1595-AD-02 study.
Summary
Brief summary (as posted)
The goal of this Phase 2 MCI study is to determine whether 1.0 mg/kg XPro1595 is superior to placebo at improving measures of cognition, functioning and brain quality in individuals with MCI and biomarkers associated with neuroinflammation (APOE4) and to evaluate safety, tolerability, and efficacy of XPro1595.
Conditions
Conditions (9)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Alzheimer Disease | — | UNRESOLVED | — |
| Brain Diseases | — | UNRESOLVED | — |
| Central Nervous System Diseases | — | UNRESOLVED | — |
| Dementia | — | UNRESOLVED | — |
| Mental Disorders | — | UNRESOLVED | — |
| Mild Cognitive Impairment (MCI) | — | UNRESOLVED | — |
| Nervous System Diseases | — | UNRESOLVED | — |
| Neurodegenerative Diseases | — | UNRESOLVED | — |
| Tauopathies | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Placebo | Drug | — | UNRESOLVED |
| XPro1595 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1.0 mg/kg XPro1595
- description
- 1.0 mg/kg XPro1595 will be administered via subcutaneous injection once a week for 12 weeks.
- interventionNames
- Drug: XPro1595
- type
- PLACEBO_COMPARATOR
- label
- 1.0 mg/kg Placebo
- description
- 1.0 mg/kg of Placebo will be administered via subcutaneous injection once a week for 12 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Change in Early and Mild Alzheimer's Cognitive Composite (EMACC)
- timeFrame
- 12 Weeks
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 55 Years
- Maximum age
- 80 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDAlvarez A, Cacabelos R, Sanpedro C, Garcia-Fantini M, Aleixandre M. Serum TNF-alpha levels are increased and correlate negatively with free IGF-I in Alzheimer disease. Neurobiol Aging. 2007 Apr;28(4):533-6. doi: 10.1016/j.neurobiolaging.2006.02.012. Epub 2006 Mar 29. PMID 16569464
- BACKGROUNDBongartz 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. PMID 16705109
- BACKGROUNDBuchhave P, Zetterberg H, Blennow K, Minthon L, Janciauskiene S, Hansson O. Soluble TNF receptors are associated with Abeta metabolism and conversion to dementia in subjects with mild cognitive impairment. Neurobiol Aging. 2010 Nov;31(11):1877-84. doi: 10.1016/j.neurobiolaging.2008.10.012. Epub 2008 Dec 13. PMID 19070941
- BACKGROUNDChance 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. PMID 21239393