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

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04867616 on ClinicalTrials.gov