Genetic Frontotemporal Dementia Initiative for Neurodevelopment
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7-17
SponsorWestern University
About this trial
This is an international multi-centre cohort study of first and second degree family members of individuals who carry Frontotemporal Dementia (FTD) mutations in MAPT, GRN or C9ORF72 repeat expansions for youths between the ages 9-17.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Written informed consent must be obtained and documented (from the participant and their substitute decision maker). This can be obtained in person or remotely.
Youths between the ages of 9 and 16 inclusive at time of enrollment, followed until age 17.
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).
Parent(s)/guardian deem appropriate to participate.
Disqualifiers
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).
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.
Lack of study partner.
For MRI: meeting any MRI incompatible criteria. Note: Participants may opt to decline MRI scans and complete the other measures.
Trial population
Youths between the ages of 9 and 16 inclusive at time of enrollment who have a 1st or 2nd degree biological relative with genetic FTD (i.e. a known mutation in biological parent or grandparent). Parents or guardians of potential GENFI NeuroDev participants are all aware of the autosomal dominant genetic nature of FTD in their family prior to being approached for potential participation in this study.
Trial design
Design model
Family-based
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Brain development as measured by structural and functional Magnetic Resonance Imaging
Time frame
Through study completion, an average of 2 yearsOther outcomes
1
Fluid biomarkers of neurodevelopment, neurodegeneration and inflammation
To examine differences compared to age matched non-carriers in physiologic signals in fluid biomarkers of synaptic markers, axonal markers, and neuroinflammation markers.
Time frame
Through study completion, an average of 2 years2
Resting State quantitative electroencephalogram (EEG)
To analyze resting state quantitative EEG (qEEG) power spectral density, a reliable metric of CNS physiology in children.
Time frame
Through study completion, an average of 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov