In Vivo PET of Synaptic Density in Cognitive Disorders: Prospective Evaluation of Neuronal Dysfunction and Relation to Symptomatology

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
SUMMARY

This study will compare the discriminative power of \[18F\]-SynVesT-1 PET and the standard-of-care \[18F\]-FDG PET in different cognitive disorders (Alzheimer's disease, Frontotemporal degeneration, dementia with Lewy bodies and late-life psychiatric disorders). Moreover, changes in \[18F\]-SynVesT-1 PET will be evaluated as well as their correlation with specific symptomatology.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
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⁃ Age between 18 and 85 years old (aimed to be evenly spread over age intervals).

⁃ Subject is judged to be in good health by the investigator on the basis of medical history, physical examination including vital signs, clinical laboratory test and urinalysis.

⁃ No history or evidence of current major neurological, internal or psychiatric disorder, based on the medical assessment and neuropsychological assessment.

⁃ In subjects \< 60 years of age, an unremarkable structural MRI scan as assessed by expert radiologist. In subjects \>= 60 years of age white matter hyperintensities corresponding to a white matter lesion (WML) score \<= 2 (of 3) on the Age-Related White Matter changes scale are acceptable.

⁃ When older than 50 years of age, subject is willing to undergo an additional 18F-NAV-4694 scan when cerebral amyloid status is unknown.

• Patients referred with uncertain diagnosis and subsequent need for FDG PET brain in their work- up to differentiate between dementing disorders or to exclude dementia in late-onset psychiatric disorders with cognitive impairment.

• A routine neuropsychological assessment has been performed during clinical work-up in the memory clinic.

• Subject is at least 30 years old.

Locations
Other Locations
Belgium
UZ Leuven
RECRUITING
Leuven
Contact Information
Primary
Koen Van Laere, MD, PhD, DSc
koen.vanlaere@uzleuven.be
+3216343714
Time Frame
Start Date: 2022-04-11
Estimated Completion Date: 2026-06
Participants
Target number of participants: 150
Treatments
Healthy controls
Synaptic density PET-MR and neuropsychological testing
Patients with Alzheimer's disease
Synaptic density PET-MR and additional neuropsychological testing (if necessary)
Patients with Frontotemporal degeneration
Synaptic density PET-MR and additional neuropsychological testing (if necessary)
Patients with Dementia with Lewy Bodies
Synaptic density PET-MR and additional neuropsychological testing (if necessary)
Patients with late-life psychiatric disorders
Synaptic density PET-MR and additional neuropsychological testing (if necessary)
Related Therapeutic Areas
Sponsors
Leads: Universitaire Ziekenhuizen KU Leuven

This content was sourced from clinicaltrials.gov