AH0003 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 Brief 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). Medical Condition Alzheimer’s Disease Min. Age 50 Years Max. Age 80 Years Who Can Join? All Status Active, not recruiting Inclusion criteria - 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 Exclusion criteria - 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 Study Medication Description Study Medication: Bepranemab Other Descriptive Name: bepranemab Placebo Yes Comparator: No Share this study Share Facebook Share Twitter Share LinkedIn Refer to a friend Via email Study Dates June 2021 Actual Start Date of Enrollment July 2025 Planned Study Completion Date General Information Study ID: AH0003 EudraCT Number: 2020-005829-88 CT.gov Number: NCT04867616 Phase: Phase 2 Locations Click here to find out where the clinical study is conducted Interested in our clinical studies? 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