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CompletedPhase 2

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

Lead sponsor

UCB Biopharma SRL

Asset

Bepranemab

Listed sites

103

Recruiting sites

-

Enrollment

466

actual

Study population

Alzheimer’s disease, MCI / preclinical Alzheimer’s

Key I/E criteria

•mild AD dementia•Amyloid biomarker required (PET/CSF)•CDR global 0.5-1•MMSE ≥20

Primary endpoint

•Clinical Dementia Rating-Sum of Boxes (CDR-SB)

Footprint

Where this trial recruits

Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.

Identifiers

Registered as

Eudract number2020-005829-88
Registry2023-506170-12EU CT Number
Org study IDAH0003
NCT IDNCT04867616
Secondary IDU1111-1293-3985Universal Trial Number (UTN)

Timeline

Milestones

Study first posted2021-04-30actual
Study start2021-06-09actual
Primary completion2024-05-24actual
Study completion2025-08-01actual
Last update posted2025-08-29actual

Assets

Drug assets

Bepranemab

Study populations

Who this study enrolls

Alzheimer’s diseaseMCI / preclinical Alzheimer’s

Eligibility

Who can enroll

Minimum age50 Years
Maximum age80 Years
SexAll
Healthy volunteersNot accepted

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

Endpoints (11)

What's being measured

Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.

Coverage by outcome category

Safety / tolerability / PK
4
Global cognition
3
Function / daily living
1
Behavior / neuropsychiatric
1
Tau biomarkers
1
Other (unclassified)
1

Global cognition

3 endpoints
Primary/protocol endpoint

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

Clinical Dementia Rating-Sum of Boxes (CDR-SB)

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From from Baseline to Week 56 and Week 80

ADAS-Cog

change from baseline, improvement

Secondary/protocol endpoint

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

Time frame:From from Baseline to Week 56 and Week 80

Mini-Mental State Examination (MMSE)

change from baseline, improvement

Function / daily living

1 endpoint
Secondary/protocol endpoint

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

Time frame:From from Baseline to Week 56 and Week 80

change from baseline, improvement

Behavior / neuropsychiatric

1 endpoint
Secondary/protocol endpoint

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

Time frame:From from Baseline to Week 80

change from baseline, improvement

Tau biomarkers

1 endpoint
Secondary/protocol endpoint

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)

Time frame:From from Baseline to Week 56 and Week 80

change from baseline, improvement

Safety / tolerability / PK

4 endpoints
Secondary/protocol endpoint

Incidence of treatment-emergent adverse events (TEAEs)

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

event count, event

Secondary/protocol endpoint

Incidence of treatment-emergent serious adverse events (TESAEs)

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

event count, event

Secondary/protocol endpoint

Incidence of TEAEs leading to discontinuation or death

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

event count, event

Secondary/protocol endpoint

Incidence of Drug-related TEAEs

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

event count, event

Other (unclassified)

1 endpoint
Secondary/protocol endpoint/low confidence

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

Time frame:From from Baseline to Week 80

concentration, descriptive

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2
Snapshot dateJuly 21, 2026
Endpoint classificationDelfa ADRD endpoint taxonomy
Results tableno registry results posted yet

Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.