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Alzheimer's DiseasePhase 2NCT04867616

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 Phase 2 study testing Bepranemab in people with Alzheimer's Disease, run by UCB Biopharma SRL at 103 sites in 10 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 50 to 80 years
Conditions the study is for
Alzheimer's Disease
What is being tested?
Bepranemab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
466 participants
Where
103 sitesin 10 countries
Study dates
9 Jun 2021to 1 Aug 2025
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • 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

Trial locations and contacts

103 sites in 10 countries.

103 sites in 10 countries

United States40 sites

  • Ah0003 50465

    Atlantis, Florida, 33462

  • Ah0003 50449

    Aventura, Florida, 33180

  • Ah0003 50440

    Bellevue, Washington, 98007

  • Ah0003 50435

    Boca Raton, Florida, 33487

  • Ah0003 50445

    Braintree, Massachusetts, 02184

  • Ah0003 50451

    Cincinnati, Ohio, 45219

  • Ah0003 50455

    Cordova, Tennessee, 38018

  • Ah0003 50479

    Decatur, Georgia, 30033

  • Ah0003 50430

    Delray Beach, Florida, 33445

  • Ah0003 50423

    East Providence, Rhode Island, 02914

  • Ah0003 50424

    Fairfax, Virginia, 22031

  • Ah0003 50429

    Fort Myers, Florida, 33912

  • Ah0003 50428

    Fresno, California, 93710

  • Ah0003 50431

    Fullerton, California, 92835

  • Ah0003 50436

    Hialeah, Florida, 33016

  • Ah0003 50380

    Houston, Texas, 77054

  • Ah0003 50442

    Irvine, California, 92614

  • Ah0003 50458

    Long Beach, California, 90807

  • Ah0003 50426

    Maitland, Florida, 32751

  • Ah0003 50427

    Miami, Florida, 33125

  • Ah0003 50478

    Naples, Florida, 34105

  • Ah0003 50420

    Neptune City, New Jersey, 07753

  • Ah0003 50422

    New Haven, Connecticut, 06510

  • Ah0003 50467

    New Haven, Connecticut, 06510

  • Ah0003 50453

    Newton, Massachusetts, 02459

  • Ah0003 50432

    Norfolk, Virginia, 23507

  • Ah0003 50464

    Ocoee, Florida, 34761

  • Ah0003 50450

    Palo Alto, California, 94303

  • Ah0003 50452

    Pasadena, California, 91106

  • Ah0003 50438

    Pensacola, Florida, 32502

  • Ah0003 50623

    Pensacola, Florida, 32503

  • Ah0003 50457

    Port Orange, Florida, 32127

  • Ah0003 50448

    Saint Paul, Minnesota, 55130

  • Ah0003 50447

    San Diego, California, 92123

  • Ah0003 50434

    Santa Ana, California, 92705

  • Ah0003 50421

    Stamford, Connecticut, 06905

  • Ah0003 50454

    Tampa, Florida, 33613

  • Ah0003 50444

    West Palm Beach, Florida, 33407

  • Ah0003 50476

    West Palm Beach, Florida, 33409

  • Ah0003 50446

    Westchester, Florida, 33155

Other trials in United States

Spain15 sites

  • Ah0003 40159

    Barcelona

  • Ah0003 40160

    Barcelona

  • Ah0003 40267

    Barcelona

  • Ah0003 40612

    Barcelona

  • Ah0003 40105

    Córdoba

  • Ah0003 40614

    Donostia / San Sebastian

  • Ah0003 40540

    Madrid

  • Ah0003 40615

    Madrid

  • Ah0003 40352

    Pamplona

  • Ah0003 40280

    Sant Cugat del Vallès

  • Ah0003 40049

    Seville

  • Ah0003 40453

    Terrassa

  • Ah0003 40230

    Valencia

  • Ah0003 40613

    Valencia

  • Ah0003 40616

    Zaragoza

Other trials in Spain

Poland11 sites

  • Ah0003 40603

    Bialystok

  • Ah0003 40606

    Bydgoszcz

  • Ah0003 40605

    Katowice

  • Ah0003 40609

    Katowice

  • Ah0003 40774

    Katowice

  • Ah0003 40638

    Ścinawa

  • Ah0003 40608

    Szczecin

  • Ah0003 40602

    Warsaw

  • Ah0003 40604

    Warsaw

  • Ah0003 40607

    Warsaw

  • Ah0003 40611

    Wroclaw

Other trials in Poland

France8 sites

  • Ah0003 40129

    Bordeaux

  • Ah0003 40580

    Bron

  • Ah0003 40493

    Marseille

  • Ah0003 40635

    Nantes

  • Ah0003 40578

    Paris

  • Ah0003 40201

    Rennes

  • Ah0003 40581

    Toulouse

  • Ah0003 40579

    Villeurbanne

Other trials in France

Canada7 sites

  • Ah0003 50463

    Kelowna

  • Ah0003 50461

    Ottawa

  • Ah0003 50520

    Québec

  • Ah0003 50045

    Toronto

  • Ah0003 50291

    Toronto

  • Ah0003 50462

    Toronto

  • Ah0003 50522

    West Vancouver

Other trials in Canada

United Kingdom7 sites

  • Ah0003 40662

    Birmingham

  • Ah0003 40619

    Bristol

  • Ah0003 40622

    Guildford

  • Ah0003 40618

    London

  • Ah0003 40621

    London

  • Ah0003 40623

    Plymouth

  • Ah0003 40691

    Winchester

Other trials in United Kingdom

Italy6 sites

  • Ah0003 40371

    Monza

  • Ah0003 40600

    Parma

  • Ah0003 40597

    Pavia

  • Ah0003 40438

    Roma

  • Ah0003 40596

    Rome

  • Ah0003 40598

    Rome

Other trials in Italy

Belgium4 sites

  • Ah0003 40123

    Brussels

  • Ah0003 40575

    Brussels

  • Ah0003 40576

    Kortrijk

  • Ah0003 40002

    Leuven

Other trials in Belgium

Netherlands3 sites

  • Ah0003 40449

    's-Hertogenbosch

  • Ah0003 40450

    Amsterdam

  • Ah0003 40601

    Zwolle

Other trials in Netherlands

Germany2 sites

  • Ah0003 40028

    Berlin

  • Ah0003 40430

    Munich

Other trials in Germany

About this study

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

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).

Being tested
Placebo, Bepranemab
Keywords
Alzheimer's Disease, Bepranemab, UCB0107, Phase 2
Medical subject headings
Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PlaceboOther

    • Pharmaceutical form: Solution for infusion
    • Route of administration: Intravenous infusion

    Participants will receive Placebo during the Double-blind Treatment Period.

  • BepranemabBiological

    • 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.

Study groups in NCT04867616
Study groupRoleWhat they receive
Dose level 1 bepranemabExperimentalParticipants 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.
Receives: Biological: Bepranemab
Dose level 2 bepranemabExperimentalParticipants 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.
Receives: Biological: Bepranemab
Placebo ArmPlacebo 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.
Receives: Other: Placebo; Biological: Bepranemab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: From from Baseline to Week 80

Secondary outcomes (10)

  1. Incidence of treatment-emergent adverse events (TEAEs)

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.

    Measured: From Baseline to the Safety Follow-Up (Week 152)

  2. Incidence of treatment-emergent serious adverse events (TESAEs)

    A serious adverse event (SAE) is any untoward medical occurrence that at any dose:

    • Results in death
    • Is life-threatening
    • Requires inpatient hospitalisation or prolongation of existing hospitalisation
    • Results in persistent or significant disability/incapacity, or
    • Is a congenital anomaly/birth defect
    • Other important medical events which based on medical or scientific judgement may jeopardize the patients, or may require medical or surgical intervention to prevent any of the above

    Measured: From Baseline to the Safety Follow-Up (Week 152)

  3. Incidence of TEAEs leading to discontinuation or death

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.tion, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.

    Measured: From Baseline to the Safety Follow-Up (Week 152)

  4. Incidence of Drug-related TEAEs

    An adverse event (AE) is any untoward medical occurrence in a patient or clinical study participant, temporally associated with the use of study medication, whether or not considered related to the study medication. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study medication.

    Measured: From Baseline to the Safety Follow-Up (Week 152)

  5. Change from Baseline in suicidal ideation and behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)

    The Columbia Suicide Severity Rating Scale (C-SSRS) is a measure used to identify and assess individuals at risk for suicide. The C-SSRS is made up of ten categories, all of which maintain binary responses (yes/no) to indicate a presence or absence of the behavior. The ten categories included in the C-SSRS are as follows: Category 1 - Wish to be Dead; Category 2 - Non-specific Active Suicidal Thoughts; Category 3 - Active Suicidal Ideation with Any Methods (Not Plan) without Intent to Act; Category 4 - Active Suicidal Ideation with Some Intent to Act, without Specific Plan; Category 5 - Active Suicidal Ideation with Specific Plan and Intent; Category 6 - Preparatory Acts or Behavior; Category 7 - Aborted Attempt; Category 8 - Interrupted Attempt; Category 9 - Actual Attempt (non-fatal); Category 10 - Completed Suicide.

    Measured: From from Baseline to Week 80

  6. Change from Baseline to Week 56 and Week 80 on indices of tau burden in the brain as measured by [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET)

    [18F]Genentech tau probe 1 (GTP1) positron emission tomography (PET) will be used to assess the brain aggregated tau burden during the study. Images will be transferred to and analyzed by a central imaging laboratory. [18F]GTP1 imaging data will be analyzed to determine the standardized uptake value ratio relative to cerebellum in multiple brain regions.

    Measured: From from Baseline to Week 56 and Week 80

  7. Change from Baseline to Week 56 and Week 80 in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14)

    The Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog14) is a composite scale (neuropsychological test battery and clinician reported outcome) that evaluates memory, orientation, attention, reasoning, language, and constructional praxis. Higher scores indicate greater impairment, with a minimum of 0 and a maximum of 90.

    Measured: From from Baseline to Week 56 and Week 80

  8. Change from Baseline to Week 56 and Week 80 in Amsterdam-Instrumental Activities of Daily Living (A-iADL)

    The Amsterdam-Instrumental Activities of Daily Living Questionnaire (A-iADL) is an adaptive and computerized observer-reported outcome measure designed to assess impairments in instrumental activities of daily living (iADL) in early dementia. The questionnaire is administered to an informant such as a relative or friend, with every effort made to use the same informant for a particular study participant throughout the study. The questionnaire consists of 70 items in 7 categories, which takes approximately 20 to 25 minutes to complete. The A-iADL assesses impairments in a broad range of daily activities including household activities, household appliances, finances, work, computer, appliances, leisure activities. The scoring range is 20 to 80 using an item response theory algorithm, with higher scores indicating better functioning (Sikkes et al, 2013).

    Measured: From from Baseline to Week 56 and Week 80

  9. Change from Baseline to Week 56 and Week 80 in Mini-Mental State Examination (MMSE) total score

    The MMSE is an 11-item neuropsychological test that is used to assess cognitive status in adults, and can be used to screen for cognitive impairment and to estimate severity of cognitive impairment. It assesses orientation, memory, attention, ability to name, ability to follow verbal and written commands, ability to write a sentence and to copy a drawing. The test takes approximately 10 to 15 minutes to complete. The score ranges from 0 to 30. Lower scores are indicative of poorer cognitive performance.

    Measured: From from Baseline to Week 56 and Week 80

  10. Serum concentrations of bepranemab over the 80-week Double-blind Treatment Period

    Serum samples will be collected for the measurement of concentrations of bepranemab at different time points during the Double-blind Treatment Period.

    Measured: From from Baseline to Week 80

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Apr 2021
  2. Study start9 Jun 2021
  3. Primary completion24 May 2024
  4. Study completion1 Aug 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Upon completion of the 80-week Double-blind Treatment Period, study participants will be eligible to enter a 48-week Open-label Extension Period with planned treatments of bepranemab for 44 weeks, followed by a Safety Follow-up Visit 20 weeks after the last infusion of investigational medicinal product.
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
466 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04867616
Sponsor's protocol ID
AH0003
Other IDs
2020-005829-88, U1111-1293-3985, 2023-506170-12, 2023
Status last verified
Jul 2026
First submitted
27 Apr 2021
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Bepranemab in people with Alzheimer's Disease, run by UCB Biopharma SRL at 103 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 103 sites in United States, Spain, Poland, France, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline to Week 80 in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) total score (time frame: From from Baseline to Week 80). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04867616.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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Clinical Trial NCT04867616 | AzTrials