Informations générales (source: ClinicalTrials.gov)
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
Interventional
Phase 2
UCB Biopharma SRL (Voir sur ClinicalTrials)
juin 2021
juillet 2025
26 avril 2025
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).
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Ah0003 40129 - Bordeaux - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40201 - Rennes - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40493 - Marseille - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40578 - Paris - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40579 - Villeurbanne - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40580 - Bron Cedex - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40581 - Toulouse - France | Contact (sur clinicalTrials) | ||||
| Ah0003 40635 - Nantes - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
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
- 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
- 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