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

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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).

Key facts

Study ID

NCT04867616

Run by

UCB Biopharma SRL

People needed

466

Starts

2021-06-09

Expected to finish

2025-08-01

Last updated by the study team

2026-07-24

Who can join

Age: 50 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 50 to 80 years of age
• Diagnosis of prodromal/mild cognitive impairment (MCI) due to Alzheimer's Disease (AD) or mild AD according to National Institute of Aging-Alzheimer's Association (NIA-AA)
• A global Clinical Dementia Rating (CDR) score of 0.5 to 1.0 and CDR-Memory Box (CDRMB) score ≥0.5 at Screening and Baseline
• Score of ≤85 for the delayed recall domain of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) at Screening
• Mini-Mental State Examination (MMSE) score ≥20 at Screening
• Participant has an identified informant that has and will maintain sufficient contact (minimum of 5 hours per week) with the participant to be able to provide accurate information on the participant's cognitive, functional, and emotional states and of the participant's personal care
• At least 6 years of formal education after the age of 5 or work experience to exclude mental deficits other than prodromal or mild AD dementia
• Evidence of cerebral Aβ accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratio assessment

You may not qualify if…

• Any evidence of a condition that may affect cognition other than AD
• Contraindications to PET imaging
• Inability to tolerate or contraindication to magnetic resonance imaging
• Any serious medical condition or abnormality that in the opinion of the investigator would preclude safe participation in and completion of the study or interfere with study assessments and/or study interpretation
• Alcohol or drug abuse within 2 years of screening
• Use of any experimental therapy within the past 6 months (or 5 half lives) prior to screening
• Previous treatment with medication intended to treat a neurodegenerative disorder (other than AD) within 1 year of screening
• Chronic daily treatment with atypical antipsychotics, opiates or opioids, benzodiazepines, barbiturates, hypnotics, or any medication with clinically significant centrally acting antihistamine or anticholinergic activitiy
• Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, or other blood products within 3 months or 5 half-lives (whichever is longer) prior to first dosing

Where it is running

• Ah0003 50431 — Fullerton, California, United States
• Ah0003 50442 — Irvine, California, United States
• Ah0003 50458 — Long Beach, California, United States
• Ah0003 50450 — Palo Alto, California, United States
• Ah0003 50452 — Pasadena, California, United States
• Ah0003 50447 — San Diego, California, United States
• Ah0003 50434 — Santa Ana, California, United States
• Ah0003 50422 — New Haven, Connecticut, United States
• Ah0003 50467 — New Haven, Connecticut, United States
• Ah0003 50421 — Stamford, Connecticut, United States
• Ah0003 50465 — Atlantis, Florida, United States
• Ah0003 50449 — Aventura, Florida, United States
• Ah0003 50435 — Boca Raton, Florida, United States
• Ah0003 50430 — Delray Beach, Florida, United States
• Ah0003 50429 — Fort Myers, Florida, United States
• Ah0003 50436 — Hialeah, Florida, United States
• Ah0003 50426 — Maitland, Florida, United States
• Ah0003 50427 — Miami, Florida, United States
• Ah0003 50478 — Naples, Florida, United States
• Ah0003 50464 — Ocoee, Florida, United States
• Ah0003 50438 — Pensacola, Florida, United States
• Ah0003 50623 — Pensacola, Florida, United States
• Ah0003 50457 — Port Orange, Florida, United States
• Ah0003 50454 — Tampa, Florida, United States
• Ah0003 50428 — Fresno, California, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.