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    Summary
    EudraCT Number:2020-001384-87
    Sponsor's Protocol Code Number:WN29722
    National Competent Authority:Germany - PEI
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2020-09-02
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedGermany - PEI
    A.2EudraCT number2020-001384-87
    A.3Full title of the trial
    A PHASE II, MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO EVALUATE THE PHARMACODYNAMIC EFFECTS OF ONCE WEEKLY ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH EARLY (PRODOMAL TO MILD) ALZHEIMER'S DISEASE
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A Study to Evaluate the Pharmacodynamic Effects of Once Weekly Administration of Gantenerumab in Participants With Early Alzheimer’s Disease
    A.4.1Sponsor's protocol code numberWN29722
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorF. Hoffmann-La Roche Ltd
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportF.Hoffmann-La Roche Ltd.
    B.4.2CountrySwitzerland
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationF.Hoffmann-La Roche Ltd.
    B.5.2Functional name of contact pointTrial Information Support Line-TISL
    B.5.3 Address:
    B.5.3.1Street AddressGrenzacherstrasse 124
    B.5.3.2Town/ cityBasel
    B.5.3.3Post codeCH-4070
    B.5.3.4CountrySwitzerland
    B.5.6E-mailglobal.rochegenentechtrials@roche.com
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation No
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameGantenerumab
    D.3.2Product code RO4909832
    D.3.4Pharmaceutical form Solution for injection
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPSubcutaneous use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNGANTENERUMAB
    D.3.9.2Current sponsor codeRO4909832
    D.3.9.3Other descriptive nameGANTENERUMAB RO4909832
    D.3.9.4EV Substance CodeSUB177613
    D.3.10 Strength
    D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number150
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin No
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product Yes
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Alzheimer's Disease (AD)
    E.1.1.1Medical condition in easily understood language
    AD is a progressive disorder that causes problems with memory, thinking and behavior. Symptoms usually develop slowly and get worse over time, becoming severe enough to interfere with daily tasks
    E.1.1.2Therapeutic area Diseases [C] - Nervous System Diseases [C10]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level HLT
    E.1.2Classification code 10001897
    E.1.2Term Alzheimer's disease (incl subtypes)
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 20.0
    E.1.2Level PT
    E.1.2Classification code 10074616
    E.1.2Term Prodromal Alzheimer's disease
    E.1.2System Organ Class 10029205 - Nervous system disorders
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    • To evaluate the pharmacodynamic (PD) effect of a once a week (Q1W) dosing regimen of gantenerumab on brain amyloid load as determined by positron emission tomography (PET) imaging in participants with early (prodromal to mild) AD
    E.2.2Secondary objectives of the trial
    • To evaluate caregiver overall satisfaction and confidence with home administration
    • To assess the safety of gantenerumab in participants with early (prodromal to mild) AD
    • To characterize the pharmacokinetic profile of gantenerumab using a new titration scheme and especially at the Q1W dosing frequency
    • To assess the PD effect of the dosing frequency on brain amyloid
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    • Age 50-90 years old
    • Probable AD dementia or prodromal AD
    • Availability of a reliable study partner who accepts to participate in study procedure throughout the study duration
    • Evidence of AD pathological process, as confirmed by amyloid PET scan by qualitative read by the core/central PET laboratory
    • Prodromal or mild symptomatology, as defined by a screening Mini-Mental State Examination score >= 22 and Clinical Dementia Rating global score of 0.5 or 1.0, as well as a clinical dementia rating memory domain score >= 0.5
    • If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 3 months prior to screening and until start of study treatment
    • Agreement not to participate in other research studies for the duration of this trial
    • For women of childbearing potential: agreement to remain abstinent or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 16 weeks after the final dose of study drug
    E.4Principal exclusion criteria
    • Any evidence of a condition other than AD that may affect cognition
    • History or presence of clinically evident systemic vascular disease that in the opinion of the investigator has the potential to affect cognitive function
    • Uncontrolled hypertension
    • Unstable or clinically significant cardiovascular, kidney or liver disease
    • History or presence of clinically evident cerebrovascular disease, posterior reversible encephalopathy syndrome, any stroke with clinical symptoms within the past 12 months, or documented history within the last 6 months of an acute event that is consistent, in the opinion of the investigator, with a transient ischemic attack
    • History of severe, clinically significant CNS trauma, history or presence of intracranial mass that could potentially impair cognition
    • Any contraindications to brain magnetic resonance imaging
    • Presence of infections that affect brain function or history of infections that resulted in neurologic sequelae
    • History or presence of systemic autoimmune disorders that potentially cause progressive neurologic disease with associated cognitive deficits
    • History of schizophrenia, schizoaffective disorder, major depression, or bipolar disorder
    • At risk for suicide in the opinion of the investigator
    • Alcohol and/or substance abuse or dependence within the past 2 years
    E.5 End points
    E.5.1Primary end point(s)
    The change from baseline to Week 52 and to Week 104 in deposited amyloid as measured by brain amyloid PET Centiloid levels
    E.5.1.1Timepoint(s) of evaluation of this end point
    From baseline (screening amyloid PET) to Week 52 and to Week 104
    E.5.2Secondary end point(s)
    1. Responses to home administration questionnaire (Caregiver) up to Week 52 and up to Week 104
    2. Nature, frequency, severity, and timing of adverse events and serious adverse events
    3. Physical examinations, vital signs, blood tests, ECGs, and ColumbiaSuicide Severity Rating Scale
    4. Nature, frequency, severity, and timing of MRI findings: amyloid-related imaging abnormalities-edema/effusion; amyloid-related imaging abnormalities-hemosiderin deposition
    5. Nature, frequency, severity, and timing of injection site reactions
    6. Presence of anti-drug antibody (ADAs) during the study relative to the presence of ADAs at baseline
    7. Plasma concentration of gantenerumab at specified timepoints
    8.The influence of dosing frequency information on the performance of a quantitative PK-PD model developed based on PK and PET from this and previous studies
    E.5.2.1Timepoint(s) of evaluation of this end point
    1. Up to Week 52 and up to Week 104
    2-7. Baseline up to end of study (Week 120)
    8. At week 52 and Week 104
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic Yes
    E.6.7Pharmacodynamic Yes
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.4.1Number of sites anticipated in Member State concerned3
    E.8.5The trial involves multiple Member States Yes
    E.8.5.1Number of sites anticipated in the EEA30
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA Yes
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    Belgium
    France
    Germany
    Italy
    Poland
    Spain
    United Kingdom
    United States
    E.8.7Trial has a data monitoring committee No
    E.8.8 Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial
    The end of the study is defined as the date when the last participant, last visit occurs or the date at which the last data point required for statistical analysis or safety follow-up is received for the last participant, whichever occurs later.
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years3
    E.8.9.1In the Member State concerned months0
    E.8.9.1In the Member State concerned days0
    E.8.9.2In all countries concerned by the trial years3
    E.8.9.2In all countries concerned by the trial months0
    E.8.9.2In all countries concerned by the trial days16
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 50
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 100
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception No
    F.3.3.2Women of child-bearing potential using contraception Yes
    F.3.3.3Pregnant women No
    F.3.3.4Nursing women No
    F.3.3.5Emergency situation No
    F.3.3.6Subjects incapable of giving consent personally Yes
    F.3.3.6.1Details of subjects incapable of giving consent
    Written consent signed by the participant (co-signed by the participant’s legally authorized representative, if required by the local regulations)
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state12
    F.4.2 For a multinational trial
    F.4.2.1In the EEA 112
    F.4.2.2In the whole clinical trial 150
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    The Sponsor will offer continued access to Roche IMP gantenerumab free of charge to eligible participants in accordance with the Roche Global Policy on Continued Access to Investigational Medicinal Product, as outlined in protocol section 4.3.5.
    The Roche Global Policy on Continued Access to Investigational Medicinal Product is available at the following website:
    http://www.roche.com/policy_continued_access_to_investigational_medicines.pdf
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-11-18
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-10-21
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
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