Studio per verificare efficacia, sicurezza e tollerabilità di bepranemab (UCB0107) in pazienti con deterioramento cognitivo o Malattia di Alzheimer (AD) lieve

Phase 1

Active, not recruiting

• Conditions: Alzheimer's Disease; MedDRA version: 20.0Level: LLTClassification code 10001896Term: Alzheimer's diseaseSystem Organ Class: 100000004852; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2020-005829-88-IT
• Lead Sponsor: CB Biopharma SR

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-08-30
• Last Update Posted: 2021-09-07

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 450

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 CDRMemory 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 Aß accumulation by either positive amyloid assessment by either positron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aß1-42 ratio assessment
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 100
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 350

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 & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified