EFRONT: Epidemiological Study in FRONtoTemporal Dementia

Sponsor

CENTOGENE GmbH Rostock (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05075187

Collaborator

(none)

4,500

Enrollment

Locations

18.9

Anticipated Duration (Months)

160.7

Patients Per Site

8.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Frontotemporal Dementia	Diagnostic Test: Genetic Screening

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

4500 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Epidemiological Study in FRONtoTemporal Dementia

Actual Study Start Date :

Sep 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Mar 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Participants diagnosed with Frontotemporal Dementia Participants diagnosed with Frontotemporal Dementia	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.

Arm

Intervention/Treatment

Participants diagnosed with Frontotemporal Dementia

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.

Outcome Measures

Primary Outcome Measures

To investigate the prevalence of genetic etiologies in FTD by genotyping FTD participants/ FTD suspected participants [15 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Damiaan	Oostende	West Flanders	Belgium	8400
2	CHU de Liege	Liège		Belgium	4000
3	Hanau Hospital	Hanau	Hessen	Germany	63450
4	Gertrudis Klinik	Leun	Hessen	Germany	35638
5	University Hospital Dresden	Dresden	Saxony	Germany	01307
6	University Medical Center Hamburg Eppendorf	Hamburg	Schleswig-Holstein	Germany	20246
7	University of Lübeck	Lübeck	Schleswig-Holstein	Germany	23562
8	RWTH Aachen University	Aachen		Germany	52074
9	Hochtaunus-Kliniken gGmbH	Bad Homburg		Germany	61352
10	University Hospital Cologne	Cologne		Germany	50937
11	University Hospital Rostock	Rostock		Germany	18057
12	Mediterraneo Hospital	Athens		Greece	16675
13	Azienda USL-IRCCS of Reggio Emilia	Reggio Emilia		Italy	42121
14	Hospital Garcia de Orta	Almada		Portugal	2805-267
15	Unidade Psiquiatrica Privada de Coimbra	Coimbra		Portugal	3000-606
16	Hospital Pedro Hispano	Matosinhos		Portugal	4464-513
17	Hospital Universitari vall D´hebron	Barcelona		Spain	08035
18	Universitary Hospital La Princesa	Madrid		Spain	28006
19	Hospital Clinico San Carlos	Madrid		Spain	28040
20	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
21	Clinica Universidad de Navarra	Pamplona		Spain	31008
22	Marqués de Valdecilla University Hospital	Santander		Spain	39011
23	Baskent University	Ankara		Turkey	06100
24	Hacettepe University	Ankara		Turkey	06100
25	Koç University Hospital	Istanbul		Turkey	34010
26	Istanbul University	Istanbul		Turkey	34080
27	Bezmialem Vakif University	Istanbul		Turkey	34093
28	Izmir Economy University Medikalpark Hospital	İzmir		Turkey	35575

Sponsors and Collaborators

CENTOGENE GmbH Rostock

Investigators

Principal Investigator: Peter Bauer, Ph.D, Centogene GmbH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

CENTOGENE GmbH Rostock

ClinicalTrials.gov Identifier:

NCT05075187

Other Study ID Numbers:

EFRONT 05-2021

First Posted:

Oct 12, 2021

Last Update Posted:

Aug 23, 2022

Last Verified:

Aug 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Dementia

Frontotemporal Dementia

Aphasia, Primary Progressive

Pick Disease of the Brain

Study Results

No Results Posted as of Aug 23, 2022