Status:
COMPLETED
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
Lead Sponsor:
UCB Biopharma SRL
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50-80 years
Phase:
PHASE2
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 o...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2025
Estimated Enrollment :
466 Patients enrolled
Trial Details
Trial ID
NCT04867616
Start Date
June 9 2021
End Date
August 1 2025
Last Update
August 29 2025
Active Locations (103)
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1
Ah0003 50428
Fresno, California, United States, 93710
2
Ah0003 50431
Fullerton, California, United States, 92835
3
Ah0003 50442
Irvine, California, United States, 92614
4
Ah0003 50458
Long Beach, California, United States, 90807