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The Dutch Parkinson-GBA Cohort Study (DUPARG) Cognitive and cholinergic function analysis in Dutch Parkinson*s patients with GBA variations.

The Dutch Parkinson-GBA Cohort Study (DUPARG) Cognitive and cholinergic function analysis in Dutch Parkinson*s patients with GBA variations. - The Dutch Parkinson-GBA Cohort Study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50798
Enrollment
205
Registered
2021-03-15
Start date
2021-06-01
Completion date
Unknown
Last updated
2024-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Parkinson Parkinson's disease

Interventions

None listed

Sponsors

Universitair Medisch Centrum Groningen
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Diagnosis Parkinson*s disease according to UK Parkinson's Disease Society Brain Bank criteria - Willingness to cooperate and sign written informed consent

Exclusion criteria

Exclusion criteria: - The refusal to be informed about an unforeseen clinical finding, Exclusion from PET: - pregnant or breast feeding women, Exclusion from MRI scan: - MRI incompatible implants in the body (e.g. prothesis, pacemakers, implanted heart valves.) - Any risk of having metal particles in the eyes due to manual work without proper eye protections - Tattoos containing red pigments that form a safety risk

Design outcomes

Primary

MeasureTime frame
The primary endpoint is the regional VAChT binding, as a measure of brain cholinergic innervation, measured with FEOBV PET imaging.

Secondary

MeasureTime frame
Secondary endpoints include (1) Neuropsychological assessment (NPA) covering all cognitive domains including questionnaires, (2) GCase activity measured using a flow cytometry based assay of peripheral blood mononuclear cells (PBMCs), (3) [18F]DOPA PET to evaluate the dopaminergic system, (4) Magnetic Resonance Imaging (MRI) and, (5) relevant clinical characteristics of the patients.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)