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

UCB

Status and phase: Active, not recruiting; Phase 2

Conditions: Alzheimer's Disease

Treatments: Other: Placebo; Biological: Bepranemab

Study type: Interventional

Funder types: Industry

Identifiers

NCT04867616

2020-005829-88 (EudraCT Number)

AH0003

Details and patient eligibility

About

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).

Enrollment: 466 patients

Sex: All

Ages: 50 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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466 participants in 3 patient groups, including a placebo group

Dose level 1 bepranemab

Experimental group

Description:

Participants randomized to this arm will receive pre-specified doses (Dose level 1) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.

Treatment:

Biological: Bepranemab

Dose level 2 bepranemab

Experimental group

Description:

Participants randomized to this arm will receive pre-specified doses (Dose level 2) of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.

Treatment:

Biological: Bepranemab

Placebo Arm

Placebo Comparator group

Description:

Participants randomized to this arm will receive Placebo to maintain the blinding during the Double-blind Treatment Period and will re-randomized during the Open-label Extension Period to receive pre-specified doses of bepranemab.

Treatment:

Biological: Bepranemab

Other: Placebo