Clinical trial NCT05075187: Epidemiological Study in FRONtoTemporal Dementia
Official title: Epidemiological Study in FRONtoTemporal Dementia
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Frontotemporal Dementia
Lead sponsor: CENTOGENE GmbH Rostock
Sponsor class: INDUSTRY
First posted: 2021-10-12
Enrollment: 4500
Sex: ALL
Minimum age (years): 25
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants diagnosed with Frontotemporal Dementia (FTD) and participants clinically suspected for FTD

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: To investigate the prevalence of genetic etiologies in FTD by genotyping FTD participants/ FTD suspected participants
timeFrame: 15 months
Secondary outcomes:
Other outcomes:
Locations:
city: Oostende
country: Belgium
facility: AZ Damiaan
state: West Flanders
city: Liège
country: Belgium
facility: CHU de Liege
city: Hanau
country: Germany
facility: Hanau Hospital
state: Hessen
city: Leun
country: Germany
facility: Gertrudis Klinik
state: Hessen
city: Dresden
country: Germany
facility: University Hospital Dresden
state: Saxony
city: Hamburg
country: Germany
facility: University Medical Center Hamburg Eppendorf
state: Schleswig-Holstein
city: Lübeck
country: Germany
facility: University of Lübeck
state: Schleswig-Holstein
city: Aachen
country: Germany
facility: RWTH Aachen University
city: Bad Homburg
country: Germany
facility: Hochtaunus-Kliniken gGmbH
city: Berlin
country: Germany
facility: AGZ of Charite Universitätsmedizin Berlin
city: Cologne
country: Germany
facility: University Hospital Cologne
city: Hamburg
country: Germany
facility: Asklepios Klinik Nord - Ochsenzoll
city: Rostock
country: Germany
facility: University Hospital Rostock
city: Athens
country: Greece
facility: Mediterraneo Hospital
city: Ioánnina
country: Greece
facility: University of Ioannina
city: Chieti
country: Italy
facility: Università degli studi Gabriele D'Annunzio Chieti-Pescara
city: Napoli
country: Italy
facility: Azienda Ospedaliera Universitaria Federico II di Napoli
city: Parma
country: Italy
facility: Azienda Ospedaliero-Universitaria di Parma
city: Reggio Emilia
country: Italy
facility: Azienda USL-IRCCS of Reggio Emilia
city: Almada
country: Portugal
facility: Hospital Garcia de Orta
city: Coimbra
country: Portugal
facility: Unidade Psiquiatrica Privada de Coimbra
city: Guimaraes
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes
city: Loures
country: Portugal
facility: Hospital Beatriz Ângelo
city: Matosinhos
country: Portugal
facility: Hospital Pedro Hispano
city: Torres Vedras
country: Portugal
facility: CNS - campus neurológico Torres Vedras
city: Barcelona
country: Spain
facility: Hospital Universitari vall D´hebron
city: Madrid
country: Spain
facility: Universitary Hospital La Princesa
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Pamplona
country: Spain
facility: Clinica Universidad de Navarra
city: Santander
country: Spain
facility: Marqués de Valdecilla University Hospital
city: Ankara
country: Turkey
facility: Baskent University
city: Ankara
country: Turkey
facility: Hacettepe University
city: Istanbul
country: Turkey
facility: Koç University Hospital
city: Istanbul
country: Turkey
facility: Istanbul University
city: Istanbul
country: Turkey
facility: Bezmialem Vakif University
city: İzmir
country: Turkey
facility: Izmir Economy University Medikalpark Hospital
Study officials:
affiliation: Centogene GmbH
name: Peter Bauer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: