SYF1b813f52676b4e8c82d2b62df97fffd8Registry ID: 2023-503705-10-00|RecruitingPhase 4
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interventional
N/A
1 country
27
Demonstrate a patient-relevant benefit of amyloid PET compared to S3 guideline diagnostics without amyloid PET on dementia-relevant morbidity endpoints.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
Not reported
Date not reportedClick on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 16, 2023
Actual (reported)Measured by investigators blinded to the intervention condition: Ability to manage activities of daily living as measured by the Amsterdam Instrumental Activities of Daily Living Questionnaire© (A-IADL-Q) score 78 weeks after randomization.
Measured by the specialist at the PET centre: occurrence of adverse events in the amyloid PET arm during and immediately after the performance of the amyloid PET examination; measured by the investigator at the trial site in the amyloid PET and control arms over the entire period of the trial: Incidence of adverse and serious adverse events (SAEs) including adverse drug reactions (ARs), mortality (also in the context of the safety assessment)
Measured via the investigator at the trial site (26 weeks after randomisation): Change in aetiological diagnosis of dementia (additional 78 weeks after randomization), change in diagnostic certainty, change in diagnostic and therapeutic (especially administration or discontinuation of medication) management.
Measured across patients and/or relatives by investigators blinded to examination condition (26, 52, 78 and 104 weeks after randomisation): Cognitive performance (ADAS-cog, MMSE), quality of life, incl. health-related quality of life (QOL-AD scale)
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Formulated product
VIZAMYL 400 MBq/mL solution for injection
The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.
SOLUTION FOR INJECTION
View registry recordThe registry names these ingredients. The formulation’s exact chemical form has not been confirmed.
VIZAMYL 400 MBq/mL solution for injection
Named ingredient: Flutemetamol (18f)
View registry recordUniversitaetsklinikum Mannheim GmbH
Mannheim, 68167, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz KöR
Mainz, 55131, Germany
Klinikum der Universitaet Muenchen AöR
Munich, 81377, Germany
Prof. Dr. Stefan Teipel
First Submitted
August 16, 2023
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Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.
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Measured across patients and/or relatives by investigators blinded to examination condition (26, 52, 78 and 104 weeks after randomisation): need for full inpatient or institutionalised outpatient care (institutionalisation) or intensification of institutionalised outpatient care as well as total duration and frequency of unplanned inpatient stays within one year (FIMA).
Measured across patients and/or relatives by investigators blinded to examination condition (78 weeks after randomization): CDR(clinical severity rating of dementia) and GDS(Geriatric Depression Scale)
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Universitaetsklinikum Tuebingen AöR
Tuebingen, 72076, Germany
Klinikum der Universitaet Muenchen AöR
Munich, 80336, Germany
University Hospital Cologne AöR
Cologne, 50937, Germany
Universitaetsklinikum Ulm AöR
Ulm, 89081, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 12203, Germany
Universitaetsmedizin Goettingen
Goettingen, 37075, Germany
Medical Center - University Of Freiburg
Freiburg Im Breisgau, 79106, Germany
University Hospital Cologne AöR
Cologne, 50937, Germany
Universitaetsklinikum Essen AöR
Essen, 45356, Germany
Klinikum rechts der Isar der TU Muenchen AöR
Munich, 81675, Germany
Universitaetsmedizin Goettingen
Goettingen, 37075, Germany
Rostock University Medical Center
Rostock, 18147, Germany
Universitaetsklinikum Magdeburg AöR
Magdeburg, 39120, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, 20251, Germany
Klinikum der Universitaet Muenchen AöR
Munich, 81377, Germany
Philipps University Marburg
Marburg, 35039, Germany
University Of Erlangen Nuremberg
Erlangen, 91054, Germany
Universitaetsmedizin Greifswald KöR
Greifswald, 17489, Germany
Technische Universitat Dresden
Dresden, 01307, Germany
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Bonn, 53127, Germany
Charite Universitaetsmedizin Berlin KöR
Berlin, 10117, Germany
Universitaet Leipzig
Leipzig, 04103, Germany
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, 35043, Germany
Central Institute Of Mental Health
Mannheim, 68159, Germany