NCT04867616

A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)

A Patient- and Investigator-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Study Participants With Prodromal to Mild Alzheimer's Disease (AD), Followed by an Open-Label Extension Period

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 466 (actual)
• Sponsor: UCB Biopharma SRL · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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

• Alzheimer's Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-06-09
• Primary completion: 2024-05-24
• Completion: 2025-08-01
• First posted: 2021-04-30
• Last updated: 2025-08-29

Locations

103 sites across 10 countries: United States, Belgium, Canada, France, Germany, Italy, Netherlands, Poland, Spain, United Kingdom

Regulatory

• FDA-regulated drug study