Parkinson's DiseasePFPNCT02760108
Parkinson's Families Project
An observational study of Parkinson's Disease and Parkinsonism, run by University College, London at 2 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease, Parkinsonism
- How many people
- 2,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Apr 2015to Jan 2027
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of capacity to consent to participate in the project.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Free London NHS Foundation Trust
London, NW3 2PF
Study Coordinator, 020 8016 8174, ion.pdresearch@ucl.ac.uk
Huw Morris, PhD, FRCP
- Recruiting
University College London Hospitals NHS Foundation Trust
London, WC1N 3BG
Study Coordinator, 020 8016 8174, ion.pdresearch@ucl.ac.uk
Huw Morris, PhD, FRCP
About this study
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:
- those who developed Parkinson's before the age of 45; and
- those who have a family history of other relatives affected by Parkinson's.
By identifying genetic factors that cause Parkinson's, we hope to understand more about the condition. Doing so will lead to the development of better diagnosis, improved disease models, and we hope in time, to the development of better treatment.
Read the detailed description
One person in every 500 has Parkinson's and around 127,000 people are living with the condition in the UK. Unfortunately, it is a progressive disease that has no cure. Many treatments are available that can improve or maintain someone's quality of life, but the investigators would like to develop treatments that can be used much earlier in the disease process. These could slow down the disease or prevent it from progressing further.
For most people who develop Parkinson's there is no clear underlying cause. However, the investigators are particularly interested in the minority of people diagnosed with Parkinson's who have either early onset disease and/or other relatives affected with Parkinson's. The investigators believe that variations in inherited material (genes) can sometimes cause the disease, and this may run in families. This opens the door to a range of studies on the effects of gene variation at a nerve cell and brain level, which the investigators hope will lead to new targeted treatments.
It is already known that some rare gene variants can cause Parkinson's. Some of these are inherited in what is called an 'autosomal dominant' way i.e. each child of a person with this type of gene change has a 50% chance of inheriting it. However, it is also known that not everyone who carries the change will go on to develop the disease. Some people appear to be protected against developing the disease and the investigators would like to understand this better. Other variants, particularly important in early onset Parkinson's are "recessive", and in this form of inheritance there is a very low risk to parents and children.
The investigators are looking closely at the genetic makeup of people with Parkinson's in comparison with unaffected people and in comparison to unaffected and affected family members in order to find out more about which gene changes can cause Parkinson's.
Following the identification of genetic variation that causes Parkinson's, in collaboration with the NHS and other researchers, the investigators plan to: 1) develop new NHS tests of Parkinson's and 2) develop new disease model which can act as a testbed for new treatments
- Conditions
- Parkinson's Disease, Parkinsonism
- Keywords
- Early onset Parkinson's disease, Familial Parkinson's disease, Parkinson's disease, Genetics
- Medical subject headings
- Parkinson Disease, Parkinsonian Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who are clinically affected by Parkinson's disease or Parkinsonism, in relation to genetic factors.
Measured: Through study completion, approximately 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2027 (estimated)
- Study completionJan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Enrolment
- 2,000 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- Parkinson's UK, Royal Free Hospital NHS Foundation Trust
- Responsible party
- Sponsor
- Investigators
- Huw Morris, PhD, FRCP, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02760108
- Sponsor's protocol ID
- 14/0800
- Acronym
- PFP
- Status last verified
- Jun 2019
- First submitted
- 22 Apr 2016
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Parkinson's Families Project
- ClinicalTrials.gov ID
- NCT02760108
- Acronym / sponsor ID
- PFP / 14/0800
- Conditions
- Parkinson's Disease, Parkinsonism
- Keywords
- Early onset Parkinson's disease, Familial Parkinson's disease, Parkinson's disease, Genetics
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- Parkinson's UK, Royal Free Hospital NHS Foundation Trust
- Study start
- Apr 2015
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Jan 2027 (estimated)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- those who developed Parkinson's before the age of 45; and
- those who have a family history of other relatives affected by Parkinson's.
By identifying genetic factors that cause Parkinson's, we hope to understand more about the condition. Doing so will lead to the development of better diagnosis, improved disease models, and we hope in time, to the development of better treatment.
Detailed description
One person in every 500 has Parkinson's and around 127,000 people are living with the condition in the UK. Unfortunately, it is a progressive disease that has no cure. Many treatments are available that can improve or maintain someone's quality of life, but the investigators would like to develop treatments that can be used much earlier in the disease process. These could slow down the disease or prevent it from progressing further.
For most people who develop Parkinson's there is no clear underlying cause. However, the investigators are particularly interested in the minority of people diagnosed with Parkinson's who have either early onset disease and/or other relatives affected with Parkinson's. The investigators believe that variations in inherited material (genes) can sometimes cause the disease, and this may run in families. This opens the door to a range of studies on the effects of gene variation at a nerve cell and brain level, which the investigators hope will lead to new targeted treatments.
It is already known that some rare gene variants can cause Parkinson's. Some of these are inherited in what is called an 'autosomal dominant' way i.e. each child of a person with this type of gene change has a 50% chance of inheriting it. However, it is also known that not everyone who carries the change will go on to develop the disease. Some people appear to be protected against developing the disease and the investigators would like to understand this better. Other variants, particularly important in early onset Parkinson's are "recessive", and in this form of inheritance there is a very low risk to parents and children.
The investigators are looking closely at the genetic makeup of people with Parkinson's in comparison with unaffected people and in comparison to unaffected and affected family members in order to find out more about which gene changes can cause Parkinson's.
Following the identification of genetic variation that causes Parkinson's, in collaboration with the NHS and other researchers, the investigators plan to: 1) develop new NHS tests of Parkinson's and 2) develop new disease model which can act as a testbed for new treatments
Study design
- Observational model
- Family based
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Month
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Lack of capacity to consent to participate in the project.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who are clinically affected by Parkinson's disease or Parkinsonism, in relation to genetic factors.
Time frame: Through study completion, approximately 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Huw Morris, PhD, FRCP principal investigator
University College, London
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson's Disease and Parkinsonism, run by University College, London at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Study Coordinator (02080168174, ion.pdresearch@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who are clinically affected by Parkinson's disease or Parkinsonism, in relation to genetic factors. (time frame: Through study completion, approximately 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2019.