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

Last updated: May 22, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Active - Not Recruiting

Phase

2

Condition

Memory Loss

Dementia

Alzheimer's Disease

Treatment

Bepranemab

Placebo

Clinical Study ID

NCT04867616
AH0003
2020-005829-88
2023-506170-12
U1111-1293-3985
  • Ages 50-80
  • All Genders

Study 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).

Eligibility Criteria

Inclusion

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 theAssessment 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 sufficientcontact (minimum of 5 hours per week) with the participant to be able to provideaccurate information on the participant's cognitive, functional, and emotionalstates and of the participant's personal care

  • At least 6 years of formal education after the age of 5 or work experience toexclude mental deficits other than prodromal or mild AD dementia

  • Evidence of cerebral Aβ accumulation by either positive amyloid assessment by eitherpositron emission tomography (PET) scan or cerebrospinal fluid pTau181/Aβ1-42 ratioassessment

Exclusion

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 investigatorwould preclude safe participation in and completion of the study or interfere withstudy 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 toscreening

  • 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 clinicallysignificant centrally acting antihistamine or anticholinergic activitiy

  • Received treatment with monoclonal antibodies (mAbs), cytokines, immunoglobulins, orother blood products within 3 months or 5 half-lives (whichever is longer) prior tofirst dosing

Study Design

Total Participants: 466
Treatment Group(s): 2
Primary Treatment: Bepranemab
Phase: 2
Study Start date:
June 09, 2021
Estimated Completion Date:
July 28, 2025

Connect with a study center

  • Ah0003 40575

    Brussel,
    Belgium

    Site Not Available

  • Ah0003 40123

    Brussels,
    Belgium

    Site Not Available

  • Ah0003 40575

    Brussels,
    Belgium

    Site Not Available

  • Ah0003 40576

    Kortrijk,
    Belgium

    Site Not Available

  • Ah0003 40002

    Leuven,
    Belgium

    Site Not Available

  • Ah0003 50520

    Gatineau,
    Canada

    Site Not Available

  • Ah0003 50463

    Kelowna,
    Canada

    Site Not Available

  • Ah0003 50461

    Ottawa,
    Canada

    Site Not Available

  • Ah0003 50520

    QC,
    Canada

    Site Not Available

  • Ah0003 50520

    Quebec,
    Canada

    Site Not Available

  • Ah0003 50045

    Toronto,
    Canada

    Site Not Available

  • Ah0003 50291

    Toronto,
    Canada

    Site Not Available

  • Ah0003 50462

    Toronto,
    Canada

    Site Not Available

  • Ah0003 50522

    West Vancouver,
    Canada

    Site Not Available

  • Ah0003 40129

    Bordeaux,
    France

    Site Not Available

  • Ah0003 40580

    Bron,
    France

    Site Not Available

  • Ah0003 40580

    Bron Cedex,
    France

    Site Not Available

  • Ah0003 40636

    Dijon,
    France

    Site Not Available

  • Ah0003 40636

    Dijon Cedex,
    France

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  • Ah0003 40493

    Marseille,
    France

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  • Ah0003 40635

    Nantes,
    France

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  • Ah0003 40578

    Paris,
    France

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  • Ah0003 40201

    Rennes,
    France

    Site Not Available

  • Ah0003 40131

    Strasbourg,
    France

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  • Ah0003 40581

    Toulouse,
    France

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  • Ah0003 40579

    Villeurbanne,
    France

    Site Not Available

  • Ah0003 40028

    Berlin,
    Germany

    Site Not Available

  • Ah0003 40430

    Munich,
    Germany

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  • Ah0003 40592

    Siegen,
    Germany

    Site Not Available

  • Ah0003 40577

    Ulm,
    Germany

    Site Not Available

  • Ah0003 40371

    Monza,
    Italy

    Site Not Available

  • Ah0003 40600

    Parma,
    Italy

    Site Not Available

  • Ah0003 40597

    Pavia,
    Italy

    Site Not Available

  • Ah0003 40497

    Pozzilli,
    Italy

    Site Not Available

  • Ah0003 40438

    Roma,
    Italy

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  • Ah0003 40596

    Rome,
    Italy

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  • Ah0003 40598

    Rome,
    Italy

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  • Ah0003 40450

    Amsterdam,
    Netherlands

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  • Ah0003 40449

    Den Bosch,
    Netherlands

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  • Ah0003 40601

    Zwolle,
    Netherlands

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  • Ah0003 40603

    Bialystok,
    Poland

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  • Ah0003 40603

    Białystok,
    Poland

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  • Ah0003 40606

    Bydgoszcz,
    Poland

    Site Not Available

  • Ah0003 40605

    Katowice,
    Poland

    Site Not Available

  • Ah0003 40609

    Katowice,
    Poland

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  • Ah0003 40774

    Katowice,
    Poland

    Site Not Available

  • Ah0003 40638

    Scinawa,
    Poland

    Site Not Available

  • Ah0003 40608

    Szczecin,
    Poland

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  • Ah0003 40604

    Warsaw,
    Poland

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  • Ah0003 40607

    Warsaw,
    Poland

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  • Ah0003 40602

    Warszawa,
    Poland

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  • Ah0003 40611

    Wroclaw,
    Poland

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  • Ah0003 40611

    Wrocław,
    Poland

    Site Not Available

  • Ah0003 40638

    Ścinawa,
    Poland

    Site Not Available

  • Ah0003 40159

    Barcelona,
    Spain

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  • Ah0003 40160

    Barcelona,
    Spain

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  • Ah0003 40267

    Barcelona,
    Spain

    Site Not Available

  • Ah0003 40612

    Barcelona,
    Spain

    Site Not Available

  • Ah0003 40105

    Cordoba,
    Spain

    Site Not Available

  • Ah0003 40105

    Córdoba,
    Spain

    Site Not Available

  • Ah0003 40614

    Donostia,
    Spain

    Site Not Available

  • Ah0003 40540

    Madrid,
    Spain

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  • Ah0003 40615

    Madrid,
    Spain

    Site Not Available

  • Ah0003 40352

    Pamplona,
    Spain

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  • Ah0003 40280

    Sant Cugat Del Valles,
    Spain

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  • Ah0003 40280

    Sant Cugat Del Vallès,
    Spain

    Site Not Available

  • Ah0003 40617

    Santander,
    Spain

    Site Not Available

  • Ah0003 40049

    Sevilla,
    Spain

    Site Not Available

  • Ah0003 40453

    Terrassa,
    Spain

    Site Not Available

  • Ah0003 40230

    Valencia,
    Spain

    Site Not Available

  • Ah0003 40613

    Valencia,
    Spain

    Site Not Available

  • Ah0003 40616

    Zaragoza,
    Spain

    Site Not Available

  • Ah0003 40662

    Birmingham,
    United Kingdom

    Site Not Available

  • Ah0003 40619

    Bristol,
    United Kingdom

    Site Not Available

  • Ah0003 40639

    Glasgow,
    United Kingdom

    Site Not Available

  • Ah0003 40619

    Gloucester,
    United Kingdom

    Site Not Available

  • Ah0003 40622

    Guildford,
    United Kingdom

    Site Not Available

  • Ah0003 40618

    London,
    United Kingdom

    Site Not Available

  • Ah0003 40621

    London,
    United Kingdom

    Site Not Available

  • Ah0003 40620

    Motherwell,
    United Kingdom

    Site Not Available

  • Ah0003 40623

    Plymouth,
    United Kingdom

    Site Not Available

  • Ah0003 40391

    Southampton,
    United Kingdom

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  • Ah0003 40691

    Winchester,
    United Kingdom

    Site Not Available

  • Ah0003 50305

    Sun City, Arizona 85351
    United States

    Site Not Available

  • Ah0003 50428

    Fresno, California 93710
    United States

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  • Ah0003 50431

    Fullerton, California 92835
    United States

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  • Ah0003 50442

    Irvine, California 92614
    United States

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  • Ah0003 50458

    Long Beach, California 90807
    United States

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  • Ah0003 50450

    Palo Alto, California 94303
    United States

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  • Ah0003 50452

    Pasadena, California 91106
    United States

    Site Not Available

  • Ah0003 50447

    San Diego, California 92123
    United States

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  • Ah0003 50434

    Santa Ana, California 92705
    United States

    Site Not Available

  • Ah0003 50422

    New Haven, Connecticut 06510
    United States

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  • Ah0003 50467

    New Haven, Connecticut 06510
    United States

    Site Not Available

  • Ah0003 50421

    Stamford, Connecticut 06905
    United States

    Site Not Available

  • Ah0003 50465

    Atlantis, Florida 33462
    United States

    Site Not Available

  • Ah0003 50449

    Aventura, Florida 33180
    United States

    Site Not Available

  • Ah0003 50435

    Boca Raton, Florida 33487
    United States

    Site Not Available

  • Ah0003 50437

    Boynton Beach, Florida 33437
    United States

    Site Not Available

  • Ah0003 50430

    Delray Beach, Florida 33445
    United States

    Site Not Available

  • Ah0003 50429

    Fort Myers, Florida 33912
    United States

    Site Not Available

  • Ah0003 50436

    Hialeah, Florida 33016
    United States

    Site Not Available

  • Ah0003 50426

    Maitland, Florida 32751
    United States

    Site Not Available

  • Ah0003 50427

    Miami, Florida 33125
    United States

    Site Not Available

  • Ah0003 50478

    Naples, Florida 34105
    United States

    Site Not Available

  • Ah0003 50464

    Ocoee, Florida 34761
    United States

    Site Not Available

  • Ah0003 50438

    Pensacola, Florida 32502
    United States

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  • Ah0003 50623

    Pensacola, Florida 32503
    United States

    Site Not Available

  • Ah0003 50457

    Port Orange, Florida 32127
    United States

    Site Not Available

  • Ah0003 50454

    Tampa, Florida 33613
    United States

    Site Not Available

  • Ah0003 50444

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Ah0003 50476

    West Palm Beach, Florida 33409
    United States

    Site Not Available

  • Ah0003 50446

    Westchester, Florida 33155
    United States

    Site Not Available

  • Ah0003 50479

    Decatur, Georgia 30033
    United States

    Site Not Available

  • Ah0003 50439

    Lexington, Kentucky 40504
    United States

    Site Not Available

  • Ah0003 50445

    Braintree, Massachusetts 02184
    United States

    Site Not Available

  • Ah0003 50453

    Newton, Massachusetts 02459
    United States

    Site Not Available

  • Ah0003 50448

    Saint Paul, Minnesota 55130
    United States

    Site Not Available

  • Ah0003 50420

    Neptune, New Jersey 07753
    United States

    Site Not Available

  • Ah0003 50451

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • Ah0003 50255

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Ah0003 50443

    Portland, Oregon 97210
    United States

    Site Not Available

  • Ah0003 50423

    East Providence, Rhode Island 02914
    United States

    Site Not Available

  • Ah0003 50455

    Cordova, Tennessee 38018
    United States

    Site Not Available

  • Ah0003 50380

    Houston, Texas 77054
    United States

    Site Not Available

  • Ah0003 50424

    Fairfax, Virginia 22031
    United States

    Site Not Available

  • Ah0003 50432

    Norfolk, Virginia 23507
    United States

    Site Not Available

  • Ah0003 50440

    Bellevue, Washington 98007
    United States

    Site Not Available

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