Trials / Withdrawn
WithdrawnNCT05321498
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Inmune Bio, Inc. · Industry
- Sex
- All
- Age
- 55 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
This study is designed as a Phase 2, double-blind randomized, placebo-controlled study investigating the safety, tolerability, and efficacy of XPro1595 in patients with MCI. The planned dose is 1.0 mg/kg of XPro1595 and matching placebo.
Conditions
- Mild Cognitive Impairment (MCI)
- Alzheimer Disease
- Dementia
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Tauopathies
- Neurodegenerative Diseases
- Mental Disorders
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
- 2023-06-01
- Primary completion
- 2023-10-26
- Completion
- 2023-10-26
- First posted
- 2022-04-11
- Last updated
- 2023-09-28
Source: ClinicalTrials.gov record NCT05321498. Inclusion in this directory is not an endorsement.