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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05075187
Other study ID # EFRONT 05-2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 1, 2021
Est. completion date September 30, 2024

Study information

Verified date November 2023
Source CENTOGENE GmbH Rostock
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

An international, multicenter, epidemiological observational study aims to investigate the prevalence of genetic etiologies in patients diagnosed with FTD or clinically suspected for FTD.


Description:

Frontotemporal dementia (FTD) is a genetically and pathologically heterogeneous neurodegenerative disease caused by the loss or damage of nerve cells in the brain's frontal and temporal lobes. This leads to abnormalities in behaviour, personality, and language comprehension problems. Also, people with FTD show movement disorders like tremor, rigidity, difficulty in coordination, muscle spasms and weakness. FTD's etiology is sporadic or heritable. Sixty to 70% of FTD cases are sporadic, while 30 to 40% are inherited (familial aggregation). For this study, blood samples were collected from clinically diagnosed or suspected FTD patients and were analysed for a broad range of pathogenic variants in genes associated with FTD. The scientific insights acquired from this study will help identify novel therapeutic targets and develop/ investigate potential disease-modifying drugs.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 4500
Est. completion date September 30, 2024
Est. primary completion date June 30, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 25 Years to 85 Years
Eligibility Inclusion Criteria: - Informed consent, which includes reference to the genetic testing, is obtained from the participant/legal guardian - The participant is aged between 25 to 85 years - The participant is diagnosed with Frontotemporal dementia (FTD) or has signs or symptoms of FTD

Study Design


Intervention

Diagnostic Test:
Genetic Screening
Blood samples will be collected from clinically diagnosed or suspected FTD patients and will be analysed for a broad range of pathogenic variants in genes associated with FTD.

Locations

Country Name City State
Belgium CHU de Liege Liège
Belgium AZ Damiaan Oostende West Flanders
Germany RWTH Aachen University Aachen
Germany Hochtaunus-Kliniken gGmbH Bad Homburg
Germany AGZ of Charite Universitätsmedizin Berlin Berlin
Germany University Hospital Cologne Cologne
Germany University Hospital Dresden Dresden Saxony
Germany Asklepios Klinik Nord - Ochsenzoll Hamburg
Germany University Medical Center Hamburg Eppendorf Hamburg Schleswig-Holstein
Germany Hanau Hospital Hanau Hessen
Germany Gertrudis Klinik Leun Hessen
Germany University of Lübeck Lübeck Schleswig-Holstein
Germany University Hospital Rostock Rostock
Greece Mediterraneo Hospital Athens
Greece University of Ioannina Ioánnina
Italy Università degli studi Gabriele D'Annunzio Chieti-Pescara Chieti
Italy Azienda Ospedaliera Universitaria Federico II di Napoli Napoli
Italy Azienda Ospedaliero-Universitaria di Parma Parma
Italy Azienda USL-IRCCS of Reggio Emilia Reggio Emilia
Portugal Hospital Garcia de Orta Almada
Portugal Unidade Psiquiatrica Privada de Coimbra Coimbra
Portugal Hospital da Senhora da Oliveira Guimaraes Guimaraes
Portugal Hospital Beatriz Ângelo Loures
Portugal Hospital Pedro Hispano Matosinhos
Portugal CNS - campus neurológico Torres Vedras Torres Vedras
Spain Hospital Universitari vall D´hebron Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario 12 de Octubre Madrid
Spain Universitary Hospital La Princesa Madrid
Spain Clinica Universidad de Navarra Pamplona
Spain Marqués de Valdecilla University Hospital Santander
Turkey Baskent University Ankara
Turkey Hacettepe University Ankara
Turkey Bezmialem Vakif University Istanbul
Turkey Istanbul University Istanbul
Turkey Koç University Hospital Istanbul
Turkey Izmir Economy University Medikalpark Hospital Izmir

Sponsors (1)

Lead Sponsor Collaborator
CENTOGENE GmbH Rostock

Countries where clinical trial is conducted

Belgium,  Germany,  Greece,  Italy,  Portugal,  Spain,  Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary To investigate the prevalence of genetic etiologies in FTD by genotyping FTD participants/ FTD suspected participants 15 months
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