Epidemiological Study in FRONtoTemporal Dementia

Frontotemporal Dementia Clinical Trial

— EFRONT  

Official title:

Epidemiological Study in FRONtoTemporal Dementia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05075187
• Other study ID #: EFRONT 05-2021
• Status: Active, not recruiting
• 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
• 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

Related Conditions & MeSH terms

• Aphasia, Primary Progressive
• Dementia
• Frontotemporal Dementia
• Pick Disease of the Brain

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