A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With M… (NCT04867616) | Clinical Trial Compass
CompletedPhase 2
A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
United States466 participantsStarted 2021-06-09
Plain-language 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).
Who can participate
Age range50 Years – 80 Years
SexALL
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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 …
What they're measuring
1
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score