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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03491150




Registration number
NCT03491150
Ethics application status
Date submitted
15/03/2018
Date registered
9/04/2018
Date last updated
13/07/2020

Titles & IDs
Public title
An Open-Label Crenezumab Study in Participants With Alzheimer's Disease
Scientific title
A Multicenter, Open-Label, Long-Term Extension Of Phase III Studies (BN29552/BN29553) Of Crenezumab In Patients With Alzheimer's Disease
Secondary ID [1] 0 0
2017-002702-12
Secondary ID [2] 0 0
BN40031
Universal Trial Number (UTN)
Trial acronym
CREAD OLE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Alzheimer's Disease 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Crenezumab

Placebo comparator: Parent Placebo - Participants (who were treated with Placebo in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).

Experimental: Parent Crenezumab - Participants (who were treated with Crenezumab in the BN29552/BN29553 Studies) received intravenous (IV) infusion of Crenezumab every 4 weeks (Q4W).


Treatment: Drugs: Crenezumab
Crenezumab was administered by intravenous (IV) infusion at 60mg/kg as per the dosing schedule described above.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timepoint [1] 0 0
Baseline up to 16 weeks after the last dose of study drug (up to 54 weeks).
Primary outcome [2] 0 0
Percentage of Participants With Anti-Crenezumab Antibodies
Timepoint [2] 0 0
Baseline up to end of study (up to 54 weeks).

Eligibility
Key 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.
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
11/04/2018
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2019
Sample size
Target
Accrual to date
Final
149
Recruitment in Australia
Recruitment state(s)
VIC,WA
Recruitment hospital [1] 0 0
Heidelberg Repatriation Hospital; Medical and Cognitive Research Centre - Heidelberg West
Recruitment hospital [2] 0 0
Neurodegenerative Disorders Research; Neurology - West Perth
Recruitment postcode(s) [1] 0 0
3081 - Heidelberg West
Recruitment postcode(s) [2] 0 0
6005 - West Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Connecticut
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
Country [4] 0 0
United States of America
State/province [4] 0 0
Georgia
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Kansas
Country [7] 0 0
United States of America
State/province [7] 0 0
Maine
Country [8] 0 0
United States of America
State/province [8] 0 0
Mississippi
Country [9] 0 0
United States of America
State/province [9] 0 0
New Jersey
Country [10] 0 0
United States of America
State/province [10] 0 0
North Carolina
Country [11] 0 0
United States of America
State/province [11] 0 0
Oklahoma
Country [12] 0 0
United States of America
State/province [12] 0 0
Oregon
Country [13] 0 0
United States of America
State/province [13] 0 0
Pennsylvania
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Canada
State/province [16] 0 0
Ontario
Country [17] 0 0
Finland
State/province [17] 0 0
Tampere
Country [18] 0 0
France
State/province [18] 0 0
Toulouse Cedec
Country [19] 0 0
Germany
State/province [19] 0 0
München
Country [20] 0 0
Hong Kong
State/province [20] 0 0
Hong Kong
Country [21] 0 0
Italy
State/province [21] 0 0
Lazio
Country [22] 0 0
Korea, Republic of
State/province [22] 0 0
Incheon
Country [23] 0 0
Korea, Republic of
State/province [23] 0 0
Seoul
Country [24] 0 0
Lithuania
State/province [24] 0 0
Vilnius
Country [25] 0 0
Mexico
State/province [25] 0 0
Culiacan
Country [26] 0 0
Mexico
State/province [26] 0 0
Monterrey
Country [27] 0 0
Mexico
State/province [27] 0 0
Saltillo
Country [28] 0 0
Poland
State/province [28] 0 0
Warszawa
Country [29] 0 0
Russian Federation
State/province [29] 0 0
Kazan
Country [30] 0 0
Russian Federation
State/province [30] 0 0
St. Petersburg
Country [31] 0 0
Spain
State/province [31] 0 0
Barcelona
Country [32] 0 0
Spain
State/province [32] 0 0
Caceres
Country [33] 0 0
Spain
State/province [33] 0 0
Navarra
Country [34] 0 0
Spain
State/province [34] 0 0
Madrid
Country [35] 0 0
Turkey
State/province [35] 0 0
Samsun
Country [36] 0 0
United Kingdom
State/province [36] 0 0
Chertsey
Country [37] 0 0
United Kingdom
State/province [37] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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 crenezumab on the underlying disease process and disease course as an exploratory efficacy objective.
Trial website
https://clinicaltrials.gov/study/NCT03491150
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT03491150