CREAD OLE

TerminatedPhase 3Results posted

An Open-Label Crenezumab Study in Participants With Alzheimer's Disease

A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease

Lead sponsor

Hoffmann-La Roche

Asset

Crenezumab

Listed sites

Recruiting sites

Enrollment

149

actual

Study population

Alzheimer’s disease

Key I/E criteria

•Study partner/caregiver required•MRI contraindications excluded

Primary endpoints

•Adverse Events (AEs) and Serious Adverse Events (SAEs)•Anti-Crenezumab Antibodies

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 number2017-002702-12

Org study IDBN40031

NCT IDNCT03491150

Timeline

Milestones

Study first posted2018-04-09actual

Study start2018-04-11actual

Primary completion2019-05-31actual

Study completion2019-05-31actual

Results first posted2020-06-09actual

Last update posted2020-07-13actual

Assets

Drug assets

Crenezumab

Study populations

Who this study enrolls

Alzheimer’s disease

Eligibility

Who can enroll

SexAll

Healthy volunteersNot accepted

Inclusion criteria

•Previous participation in Study BN29552 or BN29553 and completion of the Week 105 visit.

•Able to provide written informed consent by the patient or legally authorized representative, if required.

•Every effort to have the same caregiver participate throughout the duration of the OLE (Open Label Extension) study who also participated in Study BN29552 or BN29553.

•Willingness and ability to complete all aspects of the study [including MRI (Magnetic Resonance Imaging), lumbar puncture [if applicable], and PET (Positron Emission Tomography) imaging [if applicable].

•Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing.

•For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method and agreement to refrain from donating eggs for at least 8 weeks after last dose.

•For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use a protocol approved contraceptive method for at least 8 weeks after last dose

Exclusion criteria

•Patients who discontinued treatment permanently in Study BN29552 or BN29553 for safety reasons.

•Impaired coagulation.

•Evidence of more than 10 microbleeds and/or ARIA-H (amyloid-related imaging abnormalities-hemosiderin deposition) at the Study BN29552 or BN29553 Week 105 visit, as assessed by central review of MRI.

•Diagnosed with three recurrent, symptomatic ARIA-E (amyloid-related imaging abnormalities-edema/effusion) events or exacerbations of previous events.

•Presence of intracranial lesion that could potentially increase the risk of CNS (Central Nervous System) bleeding.

•At risk of suicide in the opinion of the investigator.

•Alcohol and/or substance abuse or dependence within the past 2 years and during the study.

•Inability to tolerate MRI procedures or contraindication to MRI, including, but not limited to, presence of pacemakers not compatible with MRI, aneurysm clips, artificial heart valves, ear implants, or foreign metal objects in the eyes, skin, or body that would contraindicate an MRI scan; or any other clinical history or examination finding that, in the judgment of the investigator, would pose a potential hazard in combination with MRI.

•Pregnant or lactating, or intending to become pregnant during the study.

•Any other severe or unstable medical condition that, in the opinion of the investigator or Sponsor, could be expected to progress, recur, or change to such an extent that it could put the patient at special risk, bias the assessment of the clinical or mental status of the patient to a significant degree, or interfere with the patient's ability to complete the study assessments.

•Chronic use of anticoagulants or participation in any other investigational drug treatment trial.

Endpoints (4)

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

Other (unclassified)

Safety / tolerability / PK

2 endpoints

Primary/protocol endpoint

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).

threshold achievement, event

Primary/registry result

Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Time frame:Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).

threshold achievement, event

Posted result

Group	Value (number), Percentage of Participants	Reported bounds
Parent PlaceboAEsn=76 Participants	32.9	-
SAEsn=76 Participants	3.9	-
Parent CrenezumabAEsn=73 Participants	42.5	-
SAEsn=73 Participants	5.5	-

Other (unclassified)

2 endpoints

Primary/protocol endpoint/low confidence

Percentage of Participants With Anti-Crenezumab Antibodies

Time frame:Baseline up to end of study (up to 54 weeks).

threshold achievement, improvement

Primary/registry result/low confidence

Percentage of Participants With Anti-Crenezumab Antibodies

Time frame:Baseline up to end of study (up to 54 weeks).

threshold achievement, improvement

Provenance

Sources

Trial identity, design, statusClinicalTrials.gov API v2

Snapshot dateJuly 21, 2026

Endpoint classificationDelfa ADRD endpoint taxonomy

Results tableClinicalTrials.gov results section

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.