A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
NCT04867616 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 466
Last updated 2025-08-29
Summary
The purpose of the study is to investigate the effect of bepranemab versus (vs) placebo on the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) up to Week 80 in study participants with prodromal or mild Alzheimer's Disease (AD).
Conditions
Interventions
- OTHER
-
Placebo
* Pharmaceutical form: Solution for infusion * Route of administration: Intravenous infusion Participants will receive Placebo during the Double-blind Treatment Period.
- BIOLOGICAL
-
Bepranemab
* Pharmaceutical form: Solution for infusion * Route of administration: Intravenous infusion Participants will receive pre-specified doses of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.
Sponsors & Collaborators
-
UCB Biopharma SRL
lead INDUSTRY
Principal Investigators
-
UCB Cares · 001 844 599 2273 (UCB)
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-09
- Primary Completion
- 2024-05-24
- Completion
- 2025-08-01
- FDA Drug
- Yes
Countries
- United States
- Belgium
- Canada
- France
- Germany
- Italy
- Netherlands
- Poland
- Spain
- United Kingdom
Study Locations
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