A Study to Test the Efficacy, Safety, and Tolerability of Bepranemab (UCB0107) in Patients With Mild Cognitive Impairment or Mild Alzheimer's Disease (AD)
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
4 other identifiers
interventional
466
10 countries
103
Brief 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2021
Typical duration for phase_2
103 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 27, 2021
CompletedFirst Posted
Study publicly available on registry
April 30, 2021
CompletedStudy Start
First participant enrolled
June 9, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 24, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2025
CompletedAugust 29, 2025
August 1, 2025
3 years
April 27, 2021
August 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score
The Clinical Dementia Rating (CDR) scale is a clinician-rated dementia staging system that tracks the progression of cognitive impairment in 6 categories (memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care). Each category is scored on a 5-point scale in which None=0, Questionable=0.5, Mild=1, Moderate=2, and Severe=3. The global CDR score is established by clinical scoring rules and has values of 0 (no dementia), 0.5, (questionable dementia), 1 (mild dementia), 2 (moderate dementia), and 3 (severe dementia). The Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) is obtained by adding the ratings in each of the 6 categories and ranges from 0 to 18 with higher scores indicative of greater impairment.
From from Baseline to Week 80
Secondary Outcomes (10)
Incidence of treatment-emergent adverse events (TEAEs)
From Baseline to the Safety Follow-Up (Week 152)
Incidence of treatment-emergent serious adverse events (TESAEs)
From Baseline to the Safety Follow-Up (Week 152)
Incidence of TEAEs leading to discontinuation or death
From Baseline to the Safety Follow-Up (Week 152)
Incidence of Drug-related TEAEs
From Baseline to the Safety Follow-Up (Week 152)
Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
From from Baseline to Week 80
- +5 more secondary outcomes
Study Arms (3)
Dose level 1 bepranemab
EXPERIMENTALParticipants 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.
Dose level 2 bepranemab
EXPERIMENTALParticipants 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.
Placebo Arm
PLACEBO COMPARATORParticipants 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.
Interventions
* Pharmaceutical form: Solution for infusion * Route of administration: Intravenous infusion Participants will receive Placebo during the Double-blind Treatment Period.
* 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
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (103)
Ah0003 50428
Fresno, California, 93710, United States
Ah0003 50431
Fullerton, California, 92835, United States
Ah0003 50442
Irvine, California, 92614, United States
Ah0003 50458
Long Beach, California, 90807, United States
Ah0003 50450
Palo Alto, California, 94303, United States
Ah0003 50452
Pasadena, California, 91106, United States
Ah0003 50447
San Diego, California, 92123, United States
Ah0003 50434
Santa Ana, California, 92705, United States
Ah0003 50422
New Haven, Connecticut, 06510, United States
Ah0003 50467
New Haven, Connecticut, 06510, United States
Ah0003 50421
Stamford, Connecticut, 06905, United States
Ah0003 50465
Atlantis, Florida, 33462, United States
Ah0003 50449
Aventura, Florida, 33180, United States
Ah0003 50435
Boca Raton, Florida, 33487, United States
Ah0003 50430
Delray Beach, Florida, 33445, United States
Ah0003 50429
Fort Myers, Florida, 33912, United States
Ah0003 50436
Hialeah, Florida, 33016, United States
Ah0003 50426
Maitland, Florida, 32751, United States
Ah0003 50427
Miami, Florida, 33125, United States
Ah0003 50478
Naples, Florida, 34105, United States
Ah0003 50464
Ocoee, Florida, 34761, United States
Ah0003 50438
Pensacola, Florida, 32502, United States
Ah0003 50623
Pensacola, Florida, 32503, United States
Ah0003 50457
Port Orange, Florida, 32127, United States
Ah0003 50454
Tampa, Florida, 33613, United States
Ah0003 50444
West Palm Beach, Florida, 33407, United States
Ah0003 50476
West Palm Beach, Florida, 33409, United States
Ah0003 50446
Westchester, Florida, 33155, United States
Ah0003 50479
Decatur, Georgia, 30033, United States
Ah0003 50445
Braintree, Massachusetts, 02184, United States
Ah0003 50453
Newton, Massachusetts, 02459, United States
Ah0003 50448
Saint Paul, Minnesota, 55130, United States
Ah0003 50420
Neptune City, New Jersey, 07753, United States
Ah0003 50451
Cincinnati, Ohio, 45219, United States
Ah0003 50423
East Providence, Rhode Island, 02914, United States
Ah0003 50455
Cordova, Tennessee, 38018, United States
Ah0003 50380
Houston, Texas, 77054, United States
Ah0003 50424
Fairfax, Virginia, 22031, United States
Ah0003 50432
Norfolk, Virginia, 23507, United States
Ah0003 50440
Bellevue, Washington, 98007, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
UCB Cares
001 844 599 2273 (UCB)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2021
First Posted
April 30, 2021
Study Start
June 9, 2021
Primary Completion
May 24, 2024
Study Completion
August 1, 2025
Last Updated
August 29, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion.
- Access Criteria
- Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.
Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of reidentifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available.