The Dutch Parkinson and Cognition Study

NCT04180865 | Unknown DMC

• 2 other identifiers: 201700171NL60540.042.17
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

Parkinson Disease (PD) is a heterogeneous, progressive neurodegenerative disorder which is characterized by a variety of motor and non-motor symptoms. The DUPARC study is a single-centre longitudinal cohort study aimed at deeply phenotyping newly diagnosed PD patients. The main aim is to investigate the relationship between cognitive impairment and both cholinergic and dopaminergic neurodegeneration in the early stages of the disease. In addition, gastrointestinal and visual system dysfunction in PD and their role in the underlying pathology are further explored in a longitudinal setup. Treatment-naïve participants will undergo extensive motor- and non-motor assessment, imaging, and microbiome assessment at time of diagnosis, and will be followed for at least 3 years.

Conditions

Parkinson Disease

Keywords

Parkinson Disease; Treatment naive; Cognition; PET imaging; Acetylcholine; Magnetic Resonance Imaging; Ophthalmology; Gastrointestinal Microbiome; Neurodegenerative Diseases; Genetic subtyping

Outcome Measures

Primary Outcomes (1)

• [18F]FEOBV PET

  Cortical and subcortical cholinergic innervation as measured by \[18F\] FEOBV PET imaging

  Baseline

Secondary Outcomes (22)

• Cognitive screening

  baseline

• Memory performance

  baseline

• Attention and working memory performance

  baseline

• Executive function performance

  baseline

• Visouspatial abilities

  baseline

Other Outcomes (11)

• Hospital Anxiety and Depression Scale

  Baseline, 1 year follow-up, 3 year follow-up

• Utrechtse Coping Lijst

  Baseline, 1 year follow-up, 3 year follow-up

• The Dysexecutive Questionnaire

  Baseline, 1 year follow-up, 3 year follow-up

Study Arms (2)

Parkinson's disease patients

150 de novo treatment naive Parkinson's disease patients.

Healthy control subjects

150 Healthy sex- and age-matched controls, also matched according to presence and severity of constipation, serving as a control group for microbiome composition analyses.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

150 PD patients who are treatment naïve at baseline, diagnosed by a movement disorders specialist, based on the Movement Disorder Society Clinical Diagnostic Criteria for PD. Patients are recruited at partnering hospitals in the northern part of the Netherlands

You may qualify if:

• \- Diagnosis Parkinson's disease

You may not qualify if:

• The refusal to be informed about an unforeseen clinical finding.
• Dopaminergic medication use.
• Pregnant women
• Breast feeding women
• MRI incompatible implants in the body (e.g. prosthesis, 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.
• Active or persistent primary disease of the gastrointestinal tract
• History of peritonitis, severe endometriosis, abdominal, intestinal or urogenital fistula,
• Hepatobiliary or pancreatic disease (except asymptomatic cholecystolithiasis)
• History of abdominal or anorectal surgery, except minor surgery such as uncomplicated appendectomy or cholecystectomy (\>6 months ago).
• Severe gynaecological prolapse (grade III)
• Cancer and/or adjuvant treatment within the last 6 months
• Within the last three months: severe hypo- or hyperkalemia, narcosis, analgosedation, endoscopic procedure of the gastrointestinal tract, abdominal trauma
• Within the last three months: gastrointestinal tract infection, food intoxication

Sponsors & Collaborators

• University Medical Center Groningen: lead
• Parkinson Platform Noord Nederland: collaborator

Study Sites (1)

University Medical Center Groningen

Groningen, 9700RB, Netherlands

RECRUITING

Related Publications (2)

• Chrysou A, Heikka T, van der Zee S, Boertien JM, Jansonius NM, van Laar T. Reduced Thickness of the Retina in de novo Parkinson's Disease Shows A Distinct Pattern, Different from Glaucoma. J Parkinsons Dis. 2024;14(3):507-519. doi: 10.3233/JPD-223481.

  PMID: 38517802 DERIVED

• Boertien JM, van der Zee S, Chrysou A, Gerritsen MJJ, Jansonius NM, Spikman JM, van Laar T; PPNN Study Group. Study protocol of the DUtch PARkinson Cohort (DUPARC): a prospective, observational study of de novo Parkinson's disease patients for the identification and validation of biomarkers for Parkinson's disease subtypes, progression and pathophysiology. BMC Neurol. 2020 Jun 13;20(1):245. doi: 10.1186/s12883-020-01811-3.

  PMID: 32534583 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Feces; Saliva; Plasma EDTA; Buffy coat (plasma EDTA); Serum;

MeSH Terms

Conditions

Parkinson Disease; Neurodegenerative Diseases

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Teus van Laar, MD PhD

  University Medical Center Groningen

  STUDY CHAIR

Central Study Contacts

Teus van Laar, MD PhD

CONTACT

+31503612400; t.van.laar@umcg.nl

Sygrid van der Zee, MSc

CONTACT

+31503612513; s.van.der.zee01@umcg.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Neurology

Study Record Dates

• First Submitted: November 4, 2019
• First Posted: November 29, 2019
• Study Start: October 1, 2017
• Primary Completion: October 1, 2023
• Study Completion: October 1, 2023
• Last Updated: November 29, 2019

Record last verified: 2019-11

Locations

NL (1)