Prodromal Alpha-Synuclein Screening in Parkinson's Disease Study

NCT04724941 | Recruiting

• 1 other identifier: PASS_PD_D440/2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief Summary

The PASS-PD study is set out to screen individuals from the general population with an increased risk for the development of Parkinson's Disease (PD) and to investigate this highly enriched cohort longitudinally for five year. A special focus is placed on implementation of ethical standards for early risk disclosure in PD.

Conditions

Parkinson Disease

Keywords

Prodromal; Alpha-Synuclein; Risk disclosure

Outcome Measures

Primary Outcomes (1)

• Risk marker profile

  Extend and progression of risk marker profile

  Analysis after three years.

Secondary Outcomes (1)

• Non-motor and motor symptoms

  Analysis after three years

Study Arms (2)

REM behavior disorder +

Individuals with REM Sleep Behavior Disorder: All individuals will be included in a prospective, longitudinal observational study, including an annual investigation at the Department for Neurology (detailed anamnesis, neurological examination, motor assessment). Blood sampling will be performed every six months, non-motor symptoms will be assessed every three months using online surveys. All individuals can participate in an optional substudy including lumbar punctures every two years.

Other: No intervention

REM behavior disorder -

Individuals without REM Sleep Behavior Disorder with increased risk for PD: All individuals will be included in a prospective, longitudinal observational study, including an annual investigation at the Department for Neurology (detailed anamnesis, neurological examination, motor assessment). Blood sampling will be performed every six months, non-motor symptoms will be assessed every three months using online surveys. All individuals can participate in an optional substudy including lumbar punctures every two years.

Other: No intervention

Interventions

No intervention OTHER

No intervention

REM behavior disorder +; REM behavior disorder -

Eligibility Criteria

• Age: 50 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

General population

You may qualify if:

• Age between 50 and 99

You may not qualify if:

• Other significant neurologic diseases affecting the central nervous system (e.g. Multiple sclerosis)
• other significant diseases e.g. orthopaedic diseases affecting quantitative motor assessment
• in case of participation in the lumbal puncture substudy: contraindications for the performance of lumbal puncture (bleeding tendency, intake of anticoagulants)

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead
• UCB Biopharma SRL: collaborator
• University of Kiel: collaborator

Study Sites (1)

Department for Neurology, University of Kiel

Kiel, 24118, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Parkinson Disease; Parkinson Disease 4, Autosomal Dominant Lewy Body

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniela Berg, Prof.Dr.

  Department for Neurology, University of Kiel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Schaeffer, Dr.

CONTACT

004943150023983; eva.schaeffer@uksh.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Eva Schaeffer, Department for Neurology

Study Record Dates

• First Submitted: January 21, 2021
• First Posted: January 26, 2021
• Study Start: June 1, 2021
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

DE (1)