A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
NCT ID: NCT04867616
Last Updated: 2025-08-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
466 participants
INTERVENTIONAL
2021-06-09
2025-08-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Dose level 1 bepranemab
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.
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.
Dose level 2 bepranemab
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.
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.
Placebo Arm
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.
Placebo
* Pharmaceutical form: Solution for infusion
* Route of administration: Intravenous infusion
Participants will receive Placebo during the Double-blind Treatment Period.
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.
Interventions
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Placebo
* Pharmaceutical form: Solution for infusion
* Route of administration: Intravenous infusion
Participants will receive Placebo during the Double-blind Treatment Period.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
50 Years
80 Years
ALL
No
Sponsors
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UCB Biopharma SRL
INDUSTRY
Responsible Party
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Principal Investigators
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UCB Cares
Role: STUDY_DIRECTOR
001 844 599 2273 (UCB)
Locations
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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
Ah0003 40621
London, , United Kingdom
Ah0003 40623
Plymouth, , United Kingdom
Ah0003 40691
Winchester, , United Kingdom
Countries
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Other Identifiers
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2020-005829-88
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1293-3985
Identifier Type: OTHER
Identifier Source: secondary_id
2023-506170-12
Identifier Type: REGISTRY
Identifier Source: secondary_id
AH0003
Identifier Type: -
Identifier Source: org_study_id
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