NCT02760108

Brief Summary

One person in every 500 has Parkinson's and around 127,000 people are living with the condition in the UK. The aim of the study is to identify new genes that predispose or cause Parkinson's Disease or Parkinsonism. There is a pressing need to study the genetic makeup of family members both with and without Parkinson's. As families share a common genetic background, it is easier to find new Parkinson's genes by studying the genetic makeup of people with Parkinson's alongside other members of their families. We are particularly interested in studying the genetic makeup of two groups of people:

  1. 1.those who developed Parkinson's before the age of 45; and
  2. 2.those who have a family history of other relatives affected by Parkinson's.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Apr 2015Jan 2027

Study Start

First participant enrolled

April 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

April 22, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 3, 2016

Completed
10.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2027

Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

11.8 years

First QC Date

April 22, 2016

Last Update Submit

June 10, 2019

Conditions

Parkinson's DiseaseParkinsonism

Keywords

Early onset Parkinson's diseaseFamilial Parkinson's diseaseParkinson's diseaseGenetics

Outcome Measures

Primary Outcomes (1)

  • Number of participants who are clinically affected by Parkinson's disease or Parkinsonism, in relation to genetic factors.

    Through study completion, approximately 10 years

Study Arms (3)

Index case

Patients with a family history of Parkinson's/parkinsonism, and/or early onset Parkinson's/parkinsonism. The first individual member from a family who is recruited to the study.

Affected relatives

Patients with Parkinson's/parkinsonism who are first or second degree relatives of an Index Case.

Unaffected relatives

Participants who do not have Parkinson's/parkinsonism and are first or second degree relatives of an Index Case.

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants will be recruited from specialist secondary care clinics at collaborating centres in the United Kingdom. Participants can also be recruited from the community, through advertisements in patient newsletters and websites.

You may qualify if:

  • Clinical diagnosis of Parkinson's disease or parkinsonism, and either family history of Parkinson's/parkinsonism (first or second degree family member affected by Parkinson's or parkinsonism) AND/OR Early onset Parkinson's/parkinsonism (symptom onset before the age of 45 years) First or second degree family member of an Index Case, affected or unaffected by Parkinson's/parkinsonism.
  • Aged over 16 years

You may not qualify if:

  • Lack of capacity to consent to participate in the project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Free London NHS Foundation Trust

London, NW3 2PF, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, WC1N 3BG, United Kingdom

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from whole blood.

MeSH Terms

Conditions

Parkinson DiseaseParkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Huw Morris, PhD, FRCP

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Coordinator

CONTACT

02080168174ion.pdresearch@ucl.ac.uk

Study Design

Study Type
observational
Observational Model
FAMILY BASED
Time Perspective
CROSS SECTIONAL
Target Duration
1 Month
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2016

First Posted

May 3, 2016

Study Start

April 1, 2015

Primary Completion (Estimated)

January 1, 2027

Study Completion (Estimated)

January 1, 2027

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Anonymous study information may made available to collaborators at other sites in the UK and overseas and may be made publicly available to bona fide researchers to enable the combined analysis of samples from different, large patient series around the world. This may include commercial companies. These are rare conditions and it is likely that sharing and collaboration between research groups and companies in different countries will be needed to make the best use of the study. Transfer of study data will be managed in a highly secure and anonymised format.

Locations

GB(2)