NCT05075187

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2021

Typical duration for all trials

Geographic Reach
7 countries

37 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2021

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

September 30, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 12, 2021

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2024

Completed
Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

2.4 years

First QC Date

September 30, 2021

Last Update Submit

April 7, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • To investigate the prevalence of genetic etiologies in FTD by genotyping FTD participants/ FTD suspected participants

    15 months

Study Arms (1)

Participants diagnosed with Frontotemporal Dementia

Participants diagnosed with Frontotemporal Dementia

Diagnostic Test: Genetic Screening

Interventions

Genetic ScreeningDIAGNOSTIC_TEST

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.

Participants diagnosed with Frontotemporal Dementia

Eligibility Criteria

Age25 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants diagnosed with Frontotemporal Dementia (FTD) and participants clinically suspected for FTD

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (37)

AZ Damiaan

Ostend, West Flanders, 8400, Belgium

Location

CHU de Liege

Liège, 4000, Belgium

Location

Hanau Hospital

Hanau, Hesse, 63450, Germany

Location

Gertrudis Klinik

Leun, Hesse, 35638, Germany

Location

University Hospital Dresden

Dresden, Saxony, 01307, Germany

Location

University Medical Center Hamburg Eppendorf

Hamburg, Schleswig-Holstein, 20246, Germany

Location

University of Lübeck

Lübeck, Schleswig-Holstein, 23562, Germany

Location

RWTH Aachen University

Aachen, 52074, Germany

Location

Hochtaunus-Kliniken gGmbH

Bad Homburg, 61352, Germany

Location

AGZ of Charite Universitätsmedizin Berlin

Berlin, 12200, Germany

Location

University Hospital Cologne

Cologne, 50937, Germany

Location

Asklepios Klinik Nord - Ochsenzoll

Hamburg, 22419, Germany

Location

University Hospital Rostock

Rostock, 18057, Germany

Location

Mediterraneo Hospital

Athens, 16675, Greece

Location

University of Ioannina

Ioannina, 45110, Greece

Location

Università degli studi Gabriele D'Annunzio Chieti-Pescara

Chieti, 66100, Italy

Location

Azienda Ospedaliera Universitaria Federico II di Napoli

Naples, 80131, Italy

Location

Azienda Ospedaliero-Universitaria di Parma

Parma, 43126, Italy

Location

Azienda USL-IRCCS of Reggio Emilia

Reggio Emilia, 42121, Italy

Location

Hospital Garcia de Orta

Almada, 2805-267, Portugal

Location

Unidade Psiquiatrica Privada de Coimbra

Coimbra, 3000-606, Portugal

Location

Hospital da Senhora da Oliveira Guimaraes

Guimarães, 4835-044, Portugal

Location

Hospital Beatriz Ângelo

Loures, 2674-514, Portugal

Location

Hospital Pedro Hispano

Matosinhos Municipality, 4464-513, Portugal

Location

CNS - campus neurológico Torres Vedras

Torres Vedras, 2560-280, Portugal

Location

Hospital Universitari vall D´hebron

Barcelona, 08035, Spain

Location

Universitary Hospital La Princesa

Madrid, 28006, Spain

Location

Hospital Clinico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Clinica Universidad de Navarra

Pamplona, 31008, Spain

Location

Marqués de Valdecilla University Hospital

Santander, 39011, Spain

Location

Baskent University

Ankara, 06100, Turkey (Türkiye)

Location

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

Koç University Hospital

Istanbul, 34010, Turkey (Türkiye)

Location

Istanbul University

Istanbul, 34080, Turkey (Türkiye)

Location

Bezmialem Vakif University

Istanbul, 34093, Turkey (Türkiye)

Location

Izmir Economy University Medikalpark Hospital

Izmir, 35575, Turkey (Türkiye)

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood sample applied on the Dry Blood Spot (DBS) Filtercard (Centocard®)

MeSH Terms

Conditions

Frontotemporal Dementia

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Frontotemporal Lobar DegenerationDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTDP-43 ProteinopathiesNeurodegenerative DiseasesProteostasis DeficienciesMetabolic DiseasesNutritional and Metabolic DiseasesNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • Peter Bauer, Ph.D

    Centogene GmbH

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2021

First Posted

October 12, 2021

Study Start

September 1, 2021

Primary Completion

January 9, 2024

Study Completion

January 9, 2024

Last Updated

April 9, 2026

Record last verified: 2026-04

Locations