Trials / Completed
CompletedNCT05384353
In Vivo PET of Synaptic Density in Cognitive Disorders
In Vivo PET of Synaptic Density in Cognitive Disorders: Prospective Evaluation of Neuronal Dysfunction and Relation to Symptomatology
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 134 (actual)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
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.
Detailed description
Forty healthy controls will be included as well as 110 patients that were referred by the UZ Leuven memory clinic with uncertain diagnosis of cognitive impairment and are already sent for \[18F\]-FDG PET imaging in their workup (estimated subgroup size: 30 patients with final diagnosis AD (aMCI); 20 patients with DLB; 30 patients with FTD; 30 patients with late-life psychiatric disorder). Scans will be acquired on a 3T GE Signa PET-MR scanner, for 90 minutes starting at injection of 150 MBq \[18F\]-SynVesT-1 for healthy controls, and from 60 to 90 minutes post injection of 150 MBq \[18F\]-SynVesT-1 for patients. For healthy controls, discrete arterial blood samples will be manually collected every 10s from 10 to 90s; every 15s from 90s to 3min; and then at 3.5, 5, 6.5, 8, 12, 15, 20, 25, 30, 45, 60, 75 and 90min. Plasma samples for correction of radiometabolites will be collected at 3, 8, 15, 30, 60 and 90min after injection. All healthy controls will also be subjected to a neuropsychological test battery and if necessary, additional limited neuropsychological testing on top of those from the memory clinic will be carried out in patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | [18F]-SynVesT-1 | PET radioligand binding to synaptic vesicle protein 2A as a proxy for synaptic density |
Timeline
- Start date
- 2022-04-11
- Primary completion
- 2025-05-28
- Completion
- 2025-06-04
- First posted
- 2022-05-20
- Last updated
- 2026-01-08
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05384353. Inclusion in this directory is not an endorsement.