Trials / Completed
CompletedNCT05318976
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
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 208 (actual)
- Sponsor
- Inmune Bio, Inc. · Industry
- Sex
- All
- Age
- 50 Years – 85 Years
- Healthy volunteers
- Not accepted
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.
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
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Neurocognitive Disorders
- Mental Disorders
- Mild Cognitive Impairment
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | XPro1595 | XPro1595 will be delivered by subcutaneous injection once a week |
| DRUG | Placebo | Placebo will be delivered by subcutaneous injection once a week |
Timeline
- Start date
- 2022-02-28
- Primary completion
- 2025-05-12
- Completion
- 2025-05-12
- First posted
- 2022-04-08
- Last updated
- 2026-03-27
Locations
41 sites across 8 countries: Australia, Canada, Czechia, France, Germany, Poland, Spain, United Kingdom
Source: ClinicalTrials.gov record NCT05318976. Inclusion in this directory is not an endorsement.