Genetic study of Frontotemporal Dementia in youth from affected families

Genetic Frontotemporal Dementia Initiative for Neurodevelopment

This study is trying to learn more about how Frontotemporal Dementia affects young people aged 9-17 who have family members with the condition by looking at their genes and doing various tests.

Quick facts

• Study type: Observational
• Enrollment: 200 (estimated)
• Ages: 7 Years to 17 Years
• Sex: All
• Sponsor: Western University (Academic / other)
• Locations: 1 site (London, Ontario)
• Trial ID: NCT05779813 on ClinicalTrials.gov

What this trial studies

This international cohort study focuses on first and second-degree family members of individuals with Frontotemporal Dementia (FTD) mutations. It aims to assess genetic FTD and related disorders in youths aged 9-17 who have a known family history of FTD. Participants will undergo longitudinal evaluations involving clinical assessments, neuropsychiatric evaluations, cognitive testing, imaging, and biosample collection. The study seeks to enhance understanding of the genetic implications of FTD in younger populations.

Who should consider this trial

Good fit: Ideal candidates are youths aged 9-16 who have a first or second-degree relative with a known genetic mutation related to Frontotemporal Dementia.

Not a fit: Patients without a family history of Frontotemporal Dementia or those with current cognitive impairments unrelated to FTD may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the early manifestations of Frontotemporal Dementia, potentially leading to improved management and support for at-risk youth.

How similar studies have performed: While there have been studies on genetic FTD, this specific focus on youth and familial connections is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Written informed consent must be obtained and documented (from the participant and their substitute decision maker). This can be obtained in person or remotely.
2. Youths between the ages of 9 and 16 inclusive at time of enrollment, followed until age 17.
3. Youths must have a 1st or 2nd degree biological relative who has participated (past or present) in the Genetic Frontotemporal Dementia Initiative (GENFI) study or with genetic FTD (i.e. a known mutation in biological parent or grandparent).
4. Parent(s)/guardian deem appropriate to participate.
5. Must have a study partner who can participate as required in the protocol (provide corroborative information). Study partner must have regular contact with the participant and must be parent/guardian of this participant.
6. Must have age-appropriate awareness that FTD runs in their family as determined by local PI.

Exclusion Criteria:

1. Current structural brain abnormality affecting cognition or behaviour not thought to be possibly related to genetic FTD that would prevent completion of study assessments (such as brain tumor, stroke, hydrocephalus).
2. Other concerns that participation in the study may not be in the best interest of the youth or parent, as raised by the participant's parent/guardian/primary care provider, local site PI or psychologist.
3. Lack of study partner.
4. For MRI: meeting any MRI incompatible criteria. Note: Participants may opt to decline MRI scans and complete the other measures.

Where this trial is running

London, Ontario

• Western University — London, Ontario, Canada (Recruiting)

Study contacts

• Principal investigator: Elizabeth Finger, MD — Western University
• Study coordinator: Kristy Coleman

Conditions Frontotemporal Dementia; Family Members