Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID04639622

GENetic Fronto Temporal Dementia Initiative in Lille

Led by University Hospital, Lille · Updated on 2026-05-22

20

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are investigating genetic frontotemporal dementia (FTD) and related disorders such as motor neuron disease (MND/ALS) in families with known mutations in the GRN or MAPT genes or expansions in the C9orf72 gene. This study aims to better describe patients with symptoms and those at risk before symptoms begin, to identify markers indicating when to start treatments, and to track disease progression. The research also seeks to help design future clinical trials by estimating appropriate sample sizes. Participants include those diagnosed with FTD or related disorders and their first-degree relatives who may carry genetic mutations or expansions linked to the disease. All participants undergo repeated assessments over time, including clinical evaluations, neuropsychiatric and cognitive tests, brain imaging with MRI and PET scans, and collection of biological samples like cerebrospinal fluid and blood. Both mutation carriers and non-carrier relatives serve as study groups to compare disease features and progression. During the study, participants will be followed longitudinally with regular visits for various assessments and tests to monitor symptoms and biomarker changes. Researchers measure the yearly proportion of symptomatic and at-risk individuals over two years as a primary outcome. Genetic analysis is performed on blood samples without sharing results with participants or investigators. The study includes safety monitoring and requires caregiver support for cognitively impaired participants. The total duration and follow-up time may vary by participant.

CONDITIONS

Brief Title

GENetic Fronto Temporal Dementia Initiative in Lille

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Participant is 18 years old or older
  • Participant is a member of a family with a known pathogenic mutation in GRN or MAPT genes, or a pathogenic expansion in the C9orf72 gene
  • Affected members have a clinical diagnosis of frontotemporal dementia or related disorder by a neurologist
  • At-risk members are first-degree relatives of affected individuals
  • For novel likely pathogenic mutations, inclusion is determined by the GENFI Genetics Core
  • Pathogenic C9orf72 expansion is defined as more than 30 repeats; intermediate expansions are excluded
  • Participants from families with two or more pathogenic mutations are excluded
  • Demented or cognitively impaired participants must have a caregiver to escort them
  • Participant must have an identified informant
  • Participant must be fluent in the language of their country of assessment
  • Participant agrees to genetic analysis of blood samples without receiving results
Not Eligible

You will not qualify if you...

  • Participant has another medical or psychiatric illness interfering with completing assessments
  • Contraindications to FDG-PET (e.g., allergy to FDG)
  • Participant is pregnant

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - 2 years

Participants undergo clinical, neuropsychiatric, cognitive assessments, imaging (MRI and PET scans), and biosample collections (CSF, blood samples) to characterize their condition or risk status.

Annual visits for assessments

Long-term Monitoring

Duration - 2 years

Participants are observed longitudinally to track disease progression and to develop markers indicative of clinical onset and progression.

Annual visits for follow-up assessments

Trial Site Locations

Total: 1 location

1

Hôpital Roger Salengro, CHRU de Lille - CMRR

Lille, France, 59000

Actively Recruiting

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Research Team

T

Thibaud LEBOUVIER, MD, Ph

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

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