Alzheimer's DiseasePhase 3CREAD OLENCT03491150
An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
A Phase 3 study testing Crenezumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 66 sites in 16 countries.
Trial summary
In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Crenezumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 149 participants
- Where
- 66 sitesin 16 countries
- Study dates
- 11 Apr 2018to 31 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
66 sites in 16 countries.
66 sites in 16 countries
United States32 sites
Senior Adults Specialty Research
Austin, Texas, 78757
Bradenton Research Center
Bradenton, Florida, 34205
Behavioral Health Research
Charlotte, North Carolina, 28211
Associated Neurologists PC - Danbury
Danbury, Connecticut, 06810
NeuroStudies.net, LLC
Decatur, Georgia, 30033
Brain Matters Research, Inc.
Delray Beach, Florida, 33445
Alexian Brothers Neurosci Inst
Elk Grove Village, Illinois, 60007
Precise Research Centers
Flowood, Mississippi, 39232
Guilford Neurologic Associates
Greensboro, North Carolina, 27401
Alzheimer's Research and Treatment Center
Lake Worth, Florida, 33414
Institute for Neurodegenerative Disorders
New Haven, Connecticut, 06510
Yale University School Of Medicine
New Haven, Connecticut, 06510
Shankle Clinic
Newport Beach, California, 92663
Sentara Medical Group
Norfolk, Virginia, 23507
Research Center for Clinical Studies, Inc.
Norwalk, Connecticut, 06851
Renstar Medical Research
Ocala, Florida, 34470
Oklahoma Clinical Research
Oklahoma City, Oklahoma, 73112
Bioclinica Research
Orlando, Florida, 32806
Progressive Medical Research
Port Orange, Florida, 32127
Summit Research Network Inc.
Portland, Oregon, 97210
MidAmerica Neuroscience Institute
Prairie Village, Kansas, 66206
Anderson Clinical Research, Inc.
Redlands, California, 92374
National Clinical Research Inc.-Richmond
Richmond, Virginia, 23294
University of California, Davis; Alzheimers Disease Center, Department of Neurology
Sacramento, California, 95817
UCSF - Memory and Aging Center
San Francisco, California, 94158
Neurological Research Inst
Santa Monica, California, 90404
MMP Neurology
Scarborough, Maine, 04074
Southern Illinois University, School of Medicine
Springfield, Illinois, 62702
The Cognitive and Research Center of New Jersey
Springfield, New Jersey, 07081
Stedman Clinical Trials, LLC
Tampa, Florida, 33613
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755
Abington Neurological Associates
Willow Grove, Pennsylvania, 19090
Spain6 sites
Fundació ACE
BArcelon, Barcelona, 08034
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, 28041
Clinica Universitaria de Navarra; Servicio de Neurología
Pamplona, Navarre, 31008
Hospital Virgen del Puerto. Servicio de Neurología
Plasencia, Caceres, 10600
Hospital General De Catalunya; Servicio de Neurologia
Sant Cugat del Vallès, Barcelona, 8195
Hospital Mutua De Terrasa; Servicio de Neurologia
Terrassa, Barcelona, 08222
Canada4 sites
Parkwood Hospital; Geriatric Medicine
London, Ontario, N6C 5J1
Kawartha Centre - Redefining Healthy Aging
Peterborough, Ontario, K9H 2P4
The Centre for Memory and Aging
Toronto, Ontario, M4G 3E8
Devonshire Clinical Research Inc.
Woodstock, Ontario, N4S 5P5
Mexico4 sites
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacán, 80020
Hospital Uni; Dr. Jose E. Gonzalez
Monterrey, 64460
AVIX Investigación Clínica S.C
Monterrey, 64710
Hospital Universitario de Saltillo
Saltillo, 25000
South Korea4 sites
Inha University Hospital
Incheon, 22332
Konkuk University Medical Center
Seoul, 05030
Asan Medical Center
Seoul, 05505
Ewha Womans University Mokdong Hospital
Seoul, 07985
Russia3 sites
State Autonomous Healthcare Institution "Republican Clinical Neurological Center
Kazan', 420021
State autonomous institution of healthcare Inter-regional clinical and diagnostic center
Kazan', 420101
SHI City Psychoneurological Dispensary #7 (with Hospital)
Saint Petersburg, 190121
Australia2 sites
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre
Heidelberg West, Victoria, 3081
Neurodegenerative Disorders Research; Neurology
West Perth, Western Australia, 6005
Italy2 sites
Fondazione Santa Lucia IRCCS
Rome, Lazio, 00179
Ospedale San Giovanni Calibita Fatebenefratell;Neurologia
Rome, Lazio, 00186
United Kingdom2 sites
Surrey and Borders NHS Foundation Trust; Research and Development Departmant; Abraham Cowley Unit
Chertsey, KT16 0AE
Charing Cross Hospital
London, W6 8RF
Germany1 site
Klinikum rechts der Isar der TU München; Klinik für Psychiatrie und Psychotherapie
München, 81675
Hong Kong1 site
Prince of Wales Hospital; Dept. of Medicine & Therapeutics
Hong Kong
Lithuania1 site
Vilnius University Hospital Santariskiu Clinic
Vilnius, 08661
Turkey (Türkiye)1 site
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139
About this study
Official title: A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease
In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
- Conditions
- Alzheimer's Disease
- Being tested
- Crenezumab
- Keywords
- Dementia, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders, Mental Disorders
- Medical subject headings
- Alzheimer Disease, Dementia, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CrenezumabDrug
Also called RO5490245
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
| Study group | Role | What they receive |
|---|---|---|
| Parent Placebo | Placebo comparator | Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). Receives: Drug: Crenezumab |
| Parent Crenezumab | Experimental | Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). Receives: Drug: Crenezumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Measured: Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
Percentage of Participants With Anti-Crenezumab Antibodies
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Measured: Baseline up to end of study (up to 54 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2018
- Study start11 Apr 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Why it stopped: This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open Label Extension (OLE)
- Masking
- None (open label)
- Enrolment
- 149 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03491150
- Sponsor's protocol ID
- BN40031
- Other IDs
- 2017-002702-12, 2017
- Acronym
- CREAD OLE
- Status last verified
- Jun 2020
- First submitted
- 15 Mar 2018
- Last updated
- 13 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT03491150
- Acronym / sponsor ID
- CREAD OLE / BN40031
- Conditions
- Alzheimer's Disease
- Keywords
- Dementia, Neurodegenerative Diseases, Brain Diseases, Central Nervous System Diseases, Nervous System Diseases, Tauopathies, Neurocognitive Disorders, Mental Disorders
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was discontinued due to an interim analysis in the BN29552 study, which indicated that Crenezumab was unlikely to meet its primary endpoint.
- Enrolment
- 149 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 11 Apr 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 9 Apr 2018 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In the BN40031 OLE study, a dose of crenezumab of 60 mg/kg intravenous (IV) every 4 weeks (Q4W) will be offered to all participants who complete Study BN29552 or BN29553 and who meet eligibility criteria in order to evaluate safety in participants on long-term crenezumab treatment and to investigate the effect of crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label Extension (OLE)
| Arm | Type | Receives |
|---|---|---|
| Parent Placebo | Placebo comparator | Drug: CrenezumabParticipants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
| Parent Crenezumab | Experimental | Drug: CrenezumabParticipants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CrenezumabAlso: RO5490245Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above. | Drug | Parent Crenezumab, Parent Placebo |
Primary outcome
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).
An Adverse Event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.
Percentage of Participants With Anti-Crenezumab Antibodies
Time frame: Baseline up to end of study (up to 54 weeks).
Participants were considered positive or negative for ADA based on their baseline and post-baseline sample results. The number and percentage of participants with confirmed positive ADA levels were determined for Crenezumab and Placebo groups. The prevalence of ADA at baseline was calculated as the proportion of participants with confirmed positive ADA levels at baseline relative to the total number of participants with a sample available at baseline. The incidence of treatment-emergent ADAs was determined as the proportion of participants with confirmed post-baseline positive ADAs relative to the total number of participants that had at least one post-baseline sample available for ADA analysis.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
66 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crenezumab in people with Alzheimer's Disease, run by Hoffmann-La Roche at 66 sites in 16 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 7 inclusion and 11 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: stopped early, as of the sponsor's last update on 13 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 66 sites in United States, Spain, Canada, Mexico, South Korea and 11 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Jul 2020.