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Clinical trials for Gantenerumab

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44335   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    7 result(s) found for: Gantenerumab. Displaying page 1 of 1.
    EudraCT Number: 2020-000766-42 Sponsor Protocol Number: WN42171 Start Date*: 2020-07-23
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL, MULTICENTER, ROLLOVER STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND EFFICACY OF LONG-TERM GANTENERUMAB ADMINISTRATION IN PARTICIPANTS WITH ALZHEIMER'S DISEASE
    Medical condition: Alzheimer's Disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10001897 Alzheimer's disease (incl subtypes) HLT
    20.0 10029205 - Nervous system disorders 10074616 Prodromal Alzheimer's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DK (Completed) PT (Prematurely Ended) PL (Prematurely Ended) HU (Completed) DE (Completed) FR (Completed) IT (Prematurely Ended) LT (Completed) NL (Completed) BE (Completed) FI (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2020-001384-87 Sponsor Protocol Number: WN29722 Start Date*: 2020-10-19
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: 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...
    Medical condition: Alzheimer's Disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10001897 Alzheimer's disease (incl subtypes) HLT
    20.0 10029205 - Nervous system disorders 10074616 Prodromal Alzheimer's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Prematurely Ended) BE (Completed) FR (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003390-95 Sponsor Protocol Number: WN28745 Start Date*: 2014-02-26
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: A Phase III, randomized, double-blind, placebo-controlled, parallel-group, multicenter efficacy and safety study of Gantenerumab in patients with Mild Alzheimer’s disease: Part II: Open-label exten...
    Medical condition: MILD ALZHEIMER’S DISEASE
    Disease: Version SOC Term Classification Code Term Level
    18.1 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed) SE (Completed) ES (Completed) PT (Completed) IT (Completed) NL (Completed) BE (Completed) HU (Completed) FI (Completed) BG (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2019-004431-23 Sponsor Protocol Number: WN41874 Start Date*: 2020-06-03
    Sponsor Name:F. Hoffmann-La Roche Ltd
    Full Title: AN OPEN-LABEL, MULTI-CENTER, ROLL-OVER STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF LONG-TERM ADMINISTRATION OF GANTENERUMAB IN PARTICIPANTS WITH ALZHEIMER’S DISEASE
    Medical condition: Alzheimer’s disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) ES (Ongoing) PL (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2017-001365-24 Sponsor Protocol Number: WN39658 Start Date*: 2018-06-05
    Sponsor Name:Roche Farma S.A.(Soc. Unipersonal) que realiza el ensayo en España y actúa como representante de F.Hoffmann-La Roche LTD
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, EFFICACY, AND SAFETY STUDY OF GANTENERUMAB IN PATIENTS WITH EARLY (PRODROMAL TO MILD) ALZHEIMER’S DISEASE
    Medical condition: Alzheimer’s Disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029205 - Nervous system disorders 10001897 Alzheimer's disease (incl subtypes) HLT
    20.0 10029205 - Nervous system disorders 10074616 Prodromal Alzheimer's disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) GB (GB - no longer in EU/EEA) DK (Completed) BE (Completed) PT (Prematurely Ended) PL (Prematurely Ended) NL (Prematurely Ended) SE (Completed) FI (Prematurely Ended) HR (Completed)
    Trial results: View results
    EudraCT Number: 2021-001184-25 Sponsor Protocol Number: WN42444 Start Date*: 2022-01-31
    Sponsor Name:Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche Ltd
    Full Title: A PHASE III, MULTICENTER, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF GANTENERUMAB IN PARTICIPANTS AT RISK FOR OR AT THE EARLIEST STAGE...
    Medical condition: Alzheimer's Disease (AD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004852 10001897 Alzheimer's disease (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing) SE (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-000307-17 Sponsor Protocol Number: DIAN-TU-001 Start Date*: 2014-01-08
    Sponsor Name:Washington University in St. Louis
    Full Title: A Phase II/III randomized, double-blind, placebo-controlled, cognitive endpoint, multicenter study of potential disease modifying therapies in individuals at risk for and with dominantly inherited ...
    Medical condition: Dominantly Inherited Alzheimer Disease (DIAD)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) IT (Trial now transitioned) ES (Temporarily Halted) DE (Trial now transitioned)
    Trial results: (No results available)
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    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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