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NCT04867616

PHASE2

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

Sponsor: UCB Biopharma SRL

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

50 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

466

Start Date

2021-06-09

Completion Date

2025-08-01

Last Updated

2026-07-24

Healthy Volunteers

Conditions

Alzheimer's Disease

Interventions

OTHER

Placebo

* Pharmaceutical form: Solution for infusion * Route of administration: Intravenous infusion Participants will receive Placebo during the Double-blind Treatment Period.

BIOLOGICAL

Bepranemab

* Pharmaceutical form: Solution for infusion * Route of administration: Intravenous infusion Participants will receive pre-specified doses of bepranemab during the Double-blind Treatment Period and the Open-label Extension Period.

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

Locations (103)

Ah0003 50428

Fresno, California, United States

Ah0003 50431

Fullerton, California, United States

Ah0003 50442

Irvine, California, United States

Ah0003 50458

Long Beach, California, United States

Ah0003 50450

Palo Alto, California, United States

Ah0003 50452

Pasadena, California, United States

Ah0003 50447

San Diego, California, United States

Ah0003 50434

Santa Ana, California, United States

Ah0003 50422

New Haven, Connecticut, United States

Ah0003 50467

New Haven, Connecticut, United States

Ah0003 50421

Stamford, Connecticut, United States

Ah0003 50465

Atlantis, Florida, United States

Ah0003 50449

Aventura, Florida, United States

Ah0003 50435

Boca Raton, Florida, United States

Ah0003 50430

Delray Beach, Florida, United States

Ah0003 50429

Fort Myers, Florida, United States

Ah0003 50436

Hialeah, Florida, United States

Ah0003 50426

Maitland, Florida, United States

Ah0003 50427

Miami, Florida, United States

Ah0003 50478

Naples, Florida, United States

Ah0003 50464

Ocoee, Florida, United States

Ah0003 50438

Pensacola, Florida, United States

Ah0003 50623

Pensacola, Florida, United States

Ah0003 50457

Port Orange, Florida, United States

Ah0003 50454

Tampa, Florida, United States

Ah0003 50444

West Palm Beach, Florida, United States

Ah0003 50476

West Palm Beach, Florida, United States

Ah0003 50446

Westchester, Florida, United States

Ah0003 50479

Decatur, Georgia, United States

Ah0003 50445

Braintree, Massachusetts, United States

Ah0003 50453

Newton, Massachusetts, United States

Ah0003 50448

Saint Paul, Minnesota, United States

Ah0003 50420

Neptune City, New Jersey, United States

Ah0003 50451

Cincinnati, Ohio, United States

Ah0003 50423

East Providence, Rhode Island, United States

Ah0003 50455

Cordova, Tennessee, United States

Ah0003 50380

Houston, Texas, United States

Ah0003 50424

Fairfax, Virginia, United States

Ah0003 50432

Norfolk, Virginia, United States

Ah0003 50440

Bellevue, Washington, United States

Ah0003 40123

Brussels, Belgium

Ah0003 40575

Brussels, Belgium

Ah0003 40576

Kortrijk, Belgium

Ah0003 40002

Leuven, Belgium

Ah0003 50463

Kelowna, Canada

Ah0003 50461

Ottawa, Canada

Ah0003 50520

Québec, Canada

Ah0003 50045

Toronto, Canada

Ah0003 50291

Toronto, Canada

Ah0003 50462

Toronto, Canada

Ah0003 50522

West Vancouver, Canada

Ah0003 40129

Bordeaux, France

Ah0003 40580

Bron, France

Ah0003 40493

Marseille, France

Ah0003 40635

Nantes, France

Ah0003 40578

Paris, France

Ah0003 40201

Rennes, France

Ah0003 40581

Toulouse, France

Ah0003 40579

Villeurbanne, France

Ah0003 40028

Berlin, Germany

Ah0003 40430

Munich, Germany

Ah0003 40371

Monza, Italy

Ah0003 40600

Parma, Italy

Ah0003 40597

Pavia, Italy

Ah0003 40438

Roma, Italy

Ah0003 40596

Rome, Italy

Ah0003 40598

Rome, Italy

Ah0003 40449

's-Hertogenbosch, Netherlands

Ah0003 40450

Amsterdam, Netherlands

Ah0003 40601

Zwolle, Netherlands

Ah0003 40603

Bialystok, Poland

Ah0003 40606

Bydgoszcz, Poland

Ah0003 40605

Katowice, Poland

Ah0003 40609

Katowice, Poland

Ah0003 40774

Katowice, Poland

Ah0003 40608

Szczecin, Poland

Ah0003 40638

Ścinawa, Poland

Ah0003 40602

Warsaw, Poland

Ah0003 40604

Warsaw, Poland

Ah0003 40607

Warsaw, Poland

Ah0003 40611

Wroclaw, Poland

Ah0003 40159

Barcelona, Spain

Ah0003 40160

Barcelona, Spain

Ah0003 40267

Barcelona, Spain

Ah0003 40612

Barcelona, Spain

Ah0003 40105

Córdoba, Spain

Ah0003 40614

Donostia / San Sebastian, Spain

Ah0003 40540

Madrid, Spain

Ah0003 40615

Madrid, Spain

Ah0003 40352

Pamplona, Spain

Ah0003 40280

Sant Cugat del Vallès, Spain

Ah0003 40049

Seville, Spain

Ah0003 40453

Terrassa, Spain

Ah0003 40230

Valencia, Spain

Ah0003 40613

Valencia, Spain

Ah0003 40616

Zaragoza, Spain

Ah0003 40662

Birmingham, United Kingdom

Ah0003 40619

Bristol, United Kingdom

Ah0003 40622

Guildford, United Kingdom

Ah0003 40618

London, United Kingdom

And 3 more locations on ClinicalTrials.gov

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (103)