AH0003
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
Refer to a friend
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