Parkinson's DiseaseNCT01351467
Web-based Genetic Research on Parkinson's Disease
An observational study of Parkinson's Disease, run by 23andMe, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to examine how genes and environment affect risk for Parkinson's disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- How many people
- 13,576 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to 23 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Community Sample
Who may be able to join
- diagnosis of Parkinson's disease by a physician
Who cannot join
- diagnoses other than Parkinson's, including:
- progressive supranuclear palsy (PSP)
- multiple system atrophy (MSA)
- Shy-Drager syndrome
- spinal cerebella ataxia (SCA)
- atypical parkinsonism
Show all 9Show fewer
- parkinsonism due to medications, drug-induced parkinsonism
- vascular parkinsonism
- frontotemporal dementia with parkinsonism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ongoing, Web-Based Genome-Wide Association Studies for Targeted Disease Initiatives
The purpose of this study is to examine how genes and environment affect risk for Parkinson's disease.
Read the detailed description
23andMe has created a web-based Parkinson's research initiative to understand the genetic associations found between Parkinson's patients' DNA and their disease. To learn more, visit: https://www.23andme.com/pd/. You can participate in this research initiative without leaving home. If you are eligible to participate, we will send you an in-home 23andMe DNA kit at no cost. We will ask you short online surveys (15-20) about your Parkinson's journey, symptoms, and response to treatment. Enrollment is on-going and open to individuals who have been diagnosed with Parkinson's disease and are residents of the U.S. Participants receive access to ancestry information and uninterpreted genetic data. Participants will also receive regular updates on our research efforts and findings.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's, genetic, online, GWAS, genome wide association
- Medical subject headings
- Parkinson Disease
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 |
|---|---|---|
| Parkinson's disease patients | People diagnosed with Parkinson's disease by a physician |
What is being measured
The primary outcome is the main question the study is designed to answer.
Saliva DNA test and online surveys with questions about Parkinson's disease experience, symptoms and response to treatment
We want to learn how genes and environment could play role in Parkinson's disease risk and progression
Measured: Intermittent surveys every 6 months for up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2011 (estimated)
- Study startApr 2009
- Primary completion23 Jun 2021
- Study completion23 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 13,576 participants (actual)
Sponsor and investigators
- Lead sponsor
- 23andMe, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, The Parkinson's Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01351467
- Sponsor's protocol ID
- 23andMe_PD001
- Status last verified
- Nov 2022
- First submitted
- 9 May 2011
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Do CB, Tung JY, Dorfman E, Kiefer AK, Drabant EM, Francke U, Mountain JL, Goldman SM, Tanner CM, Langston JW, Wojcicki A, Eriksson N. Web-based genome-wide association study identifies two novel loci and a substantial genetic component for Parkinson's disease. PLoS Genet. 2011 Jun;7(6):e1002141. doi: 10.1371/journal.pgen.1002141. Epub 2011 Jun 23.
PubMed 21738487Lill CM, Roehr JT, McQueen MB, Kavvoura FK, Bagade S, Schjeide BM, Schjeide LM, Meissner E, Zauft U, Allen NC, Liu T, Schilling M, Anderson KJ, Beecham G, Berg D, Biernacka JM, Brice A, DeStefano AL, Do CB, Eriksson N, Factor SA, Farrer MJ, Foroud T, Gasser T, Hamza T, Hardy JA, Heutink P, Hill-Burns EM, Klein C, Latourelle JC, Maraganore DM, Martin ER, Martinez M, Myers RH, Nalls MA, Pankratz N, Payami H, Satake W, Scott WK, Sharma M, Singleton AB, Stefansson K, Toda T, Tung JY, Vance J, Wood NW, Zabetian CP; 23andMe Genetic Epidemiology of Parkinson's Disease Consortium; International Parkinson's Disease Genomics Consortium; Parkinson's Disease GWAS Consortium; Wellcome Trust Case Control Consortium 2); Young P, Tanzi RE, Khoury MJ, Zipp F, Lehrach H, Ioannidis JP, Bertram L. Comprehensive research synopsis and systematic meta-analyses in Parkinson's disease genetics: The PDGene database. PLoS Genet. 2012;8(3):e1002548. doi: 10.1371/journal.pgen.1002548. Epub 2012 Mar 15.
PubMed 22438815Pichler I, Del Greco M F, Gogele M, Lill CM, Bertram L, Do CB, Eriksson N, Foroud T, Myers RH; PD GWAS Consortium; Nalls M, Keller MF; International Parkinson's Disease Genomics Consortium; Wellcome Trust Case Control Consortium 2; Benyamin B, Whitfield JB; Genetics of Iron Status Consortium; Pramstaller PP, Hicks AA, Thompson JR, Minelli C. Serum iron levels and the risk of Parkinson disease: a Mendelian randomization study. PLoS Med. 2013;10(6):e1001462. doi: 10.1371/journal.pmed.1001462. Epub 2013 Jun 4.
PubMed 23750121Nalls MA, Pankratz N, Lill CM, Do CB, Hernandez DG, Saad M, DeStefano AL, Kara E, Bras J, Sharma M, Schulte C, Keller MF, Arepalli S, Letson C, Edsall C, Stefansson H, Liu X, Pliner H, Lee JH, Cheng R; International Parkinson's Disease Genomics Consortium (IPDGC); Parkinson's Study Group (PSG) Parkinson's Research: The Organized GENetics Initiative (PROGENI); 23andMe; GenePD; NeuroGenetics Research Consortium (NGRC); Hussman Institute of Human Genomics (HIHG); Ashkenazi Jewish Dataset Investigator; Cohorts for Health and Aging Research in Genetic Epidemiology (CHARGE); North American Brain Expression Consortium (NABEC); United Kingdom Brain Expression Consortium (UKBEC); Greek Parkinson's Disease Consortium; Alzheimer Genetic Analysis Group; Ikram MA, Ioannidis JP, Hadjigeorgiou GM, Bis JC, Martinez M, Perlmutter JS, Goate A, Marder K, Fiske B, Sutherland M, Xiromerisiou G, Myers RH, Clark LN, Stefansson K, Hardy JA, Heutink P, Chen H, Wood NW, Houlden H, Payami H, Brice A, Scott WK, Gasser T, Bertram L, Eriksson N, Foroud T, Singleton AB. Large-scale meta-analysis of genome-wide association data identifies six new risk loci for Parkinson's disease. Nat Genet. 2014 Sep;46(9):989-93. doi: 10.1038/ng.3043. Epub 2014 Jul 27.
PubMed 25064009
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ongoing, Web-Based Genome-Wide Association Studies for Targeted Disease Initiatives
- ClinicalTrials.gov ID
- NCT01351467
- Acronym / sponsor ID
- 23andMe_PD001
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's, genetic, online, GWAS, genome wide association
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13,576 participants (actual)
- Lead sponsor
- 23andMe, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research, The Parkinson's Institute
- Study start
- Apr 2009
- Primary completion
- 23 Jun 2021 (actual)
- Study completion
- 23 Jun 2021 (actual)
- First posted
- 11 May 2011 (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.
The purpose of this study is to examine how genes and environment affect risk for Parkinson's disease.
Detailed description
23andMe has created a web-based Parkinson's research initiative to understand the genetic associations found between Parkinson's patients' DNA and their disease. To learn more, visit: https://www.23andme.com/pd/. You can participate in this research initiative without leaving home. If you are eligible to participate, we will send you an in-home 23andMe DNA kit at no cost. We will ask you short online surveys (15-20) about your Parkinson's journey, symptoms, and response to treatment. Enrollment is on-going and open to individuals who have been diagnosed with Parkinson's disease and are residents of the U.S. Participants receive access to ancestry information and uninterpreted genetic data. Participants will also receive regular updates on our research efforts and findings.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease patients | – | –People diagnosed with Parkinson's disease by a physician |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community Sample
Key inclusion criteria (1 listed)
- diagnosis of Parkinson's disease by a physician
Key exclusion criteria (9 listed)
- diagnoses other than Parkinson's, including:
- progressive supranuclear palsy (PSP)
- multiple system atrophy (MSA)
- Shy-Drager syndrome
- spinal cerebella ataxia (SCA)
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
Saliva DNA test and online surveys with questions about Parkinson's disease experience, symptoms and response to treatment
Time frame: Intermittent surveys every 6 months for up to 24 months
We want to learn how genes and environment could play role in Parkinson's disease risk and progression
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Results publication: PubMed 21738487Do CB, Tung JY, Dorfman E, Kiefer AK, Drabant EM, Francke U, Mountain JL, Goldman SM, Tanner CM, Langston JW, Wojcicki A, Eriksson N. Web-based genome-wide association study identifies two novel loci and a substantial genetic component for Parkinson's disease. PLoS Genet. 2011 Jun;7(6):e1002141. doi: 10.1371/journal.pgen.1002141. Epub 2011 Jun 23.
- Results publication: PubMed 22438815Lill CM, Roehr JT, McQueen MB, Kavvoura FK, Bagade S, Schjeide BM, Schjeide LM, Meissner E, Zauft U, Allen NC, Liu T, Schilling M, Anderson KJ, Beecham G, Berg D, Biernacka JM, Brice A, DeStefano AL, Do CB, Eriksson N, Factor SA, Farrer MJ, Foroud T, Gasser T, Hamza T, Hardy JA, Heutink P, Hill-Burns EM, Klein C, Latourelle JC, Maraganore DM, Martin ER, Martinez M, Myers RH, Nalls MA, Pankratz N, Payami H, Satake W, Scott WK, Sharma M, Singleton AB, Stefansson K, Toda T, Tung JY, Vance J, Wood NW, Zabetian CP; 23andMe Genetic Epidemiology of Parkinson's Disease Consortium; International Parkinson's Disease Genomics Consortium; Parkinson's Disease GWAS Consortium; Wellcome Trust Case Control Consortium 2); Young P, Tanzi RE, Khoury MJ, Zipp F, Lehrach H, Ioannidis JP, Bertram L. Comprehensive research synopsis and systematic meta-analyses in Parkinson's disease genetics: The PDGene database. PLoS Genet. 2012;8(3):e1002548. doi: 10.1371/journal.pgen.1002548. Epub 2012 Mar 15.
- Results publication: PubMed 23750121Pichler I, Del Greco M F, Gogele M, Lill CM, Bertram L, Do CB, Eriksson N, Foroud T, Myers RH; PD GWAS Consortium; Nalls M, Keller MF; International Parkinson's Disease Genomics Consortium; Wellcome Trust Case Control Consortium 2; Benyamin B, Whitfield JB; Genetics of Iron Status Consortium; Pramstaller PP, Hicks AA, Thompson JR, Minelli C. Serum iron levels and the risk of Parkinson disease: a Mendelian randomization study. PLoS Med. 2013;10(6):e1001462. doi: 10.1371/journal.pmed.1001462. Epub 2013 Jun 4.
- Results publication: PubMed 25064009Nalls MA, Pankratz N, Lill CM, Do CB, Hernandez DG, Saad M, DeStefano AL, Kara E, Bras J, Sharma M, Schulte C, Keller MF, Arepalli S, Letson C, Edsall C, Stefansson H, Liu X, Pliner H, Lee JH, Cheng R; International Parkinson's Disease Genomics Consortium (IPDGC); Parkinson's Study Group (PSG) Parkinson's Research: The Organized GENetics Initiative (PROGENI); 23andMe; GenePD; NeuroGenetics Research Consortium (NGRC); Hussman Institute of Human Genomics (HIHG); Ashkenazi Jewish Dataset Investigator; Cohorts for Health and Aging Research in Genetic Epidemiology (CHARGE); North American Brain Expression Consortium (NABEC); United Kingdom Brain Expression Consortium (UKBEC); Greek Parkinson's Disease Consortium; Alzheimer Genetic Analysis Group; Ikram MA, Ioannidis JP, Hadjigeorgiou GM, Bis JC, Martinez M, Perlmutter JS, Goate A, Marder K, Fiske B, Sutherland M, Xiromerisiou G, Myers RH, Clark LN, Stefansson K, Hardy JA, Heutink P, Chen H, Wood NW, Houlden H, Payami H, Brice A, Scott WK, Gasser T, Bertram L, Eriksson N, Foroud T, Singleton AB. Large-scale meta-analysis of genome-wide association data identifies six new risk loci for Parkinson's disease. Nat Genet. 2014 Sep;46(9):989-93. doi: 10.1038/ng.3043. Epub 2014 Jul 27.
- Click here for more information about this study: Web-based Genetic Research on Parkinson's DiseaseLink provided by the sponsor.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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, run by 23andMe, Inc. at 1 site in United States.
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 1 inclusion and 9 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: finished, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Saliva DNA test and online surveys with questions about Parkinson's disease experience, symptoms and response to treatment (time frame: Intermittent surveys every 6 months for up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01351467, which also lists 4 linked publications.
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 3 Nov 2022.