Parkinson's DiseaseLab2LifeNCT00917280
Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in Parkinson's Disease (PD) Without Dementia
An observational study of Parkinson's Disease, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life. Read more about this study
- Who is it for?
- Ages 40 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- How many people
- 174 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Jul 2014
- 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 40 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Controls: Recruited from community, VFH.
Who may be able to join
- WUSM Movement Disorders Clinic patients
- males or females between 40 and 70
- meet criteria for idiopathic typical PD
- classified at Hoehn \& Yahr12 stage I, II, or III
- are currently treated with levodopa/carbidopa
- The groups will be matched for age, education and gender
- No Parkinson Disease
Who cannot join
- suspected dementia
- treatment with certain dopaminergic, anticholinergic or benzodiazepine medications
- other neurological problems
- brain surgery
- history or current psychotic disorder
- any condition which would interfere with testing
- control only: a biological family history of PD and being a caregiver or spouse of someone who has PD
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in PD Without Dementia
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.
Read the detailed description
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- 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 | Parkinson Disease participants without dementia | |
| Control | Non-PD participants, matched for age, education and gender. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2009 (estimated)
- Study startDec 2008
- Primary completionJul 2014
- Study completionJul 2014
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 Washington University School of MedicineThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erin Foster, Washington University School of Medicine
- Investigators
- Erin Foster, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00917280
- Sponsor's protocol ID
- #E07-117
- Acronym
- Lab2Life
- Status last verified
- Jun 2015
- First submitted
- 8 Jun 2009
- Last updated
- 3 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Connecting the Lab to Everyday Life: The Relevance of Executive Dysfunction to Participation and Quality of Life in PD Without Dementia
- ClinicalTrials.gov ID
- NCT00917280
- Acronym / sponsor ID
- Lab2Life / #E07-117
- Conditions
- Parkinson's Disease
- Keywords
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 174 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 10 Jun 2009 (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 overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.
Detailed description
The overall purpose of this research is to learn how Parkinson's disease affects thinking and memory in everyday life. Participation will involve thinking tests, questionnaires and interviews about thinking and activities in everyday life.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Disease | – | –Parkinson Disease participants without dementia |
| Control | – | –Non-PD participants, matched for age, education and gender. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Controls: Recruited from community, VFH.
Key inclusion criteria (7 listed)
- WUSM Movement Disorders Clinic patients
- males or females between 40 and 70
- meet criteria for idiopathic typical PD
- classified at Hoehn \& Yahr12 stage I, II, or III
- are currently treated with levodopa/carbidopa
Key exclusion criteria (7 listed)
- suspected dementia
- treatment with certain dopaminergic, anticholinergic or benzodiazepine medications
- other neurological problems
- brain surgery
- history or current psychotic disorder
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
Not reported in the source record.
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 Jun 2015.
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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.
Erin Foster principal investigator
Washington University School of Medicine
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 Washington University School of Medicine 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 7 inclusion and 7 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 Jun 2015. 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.
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 3 Jun 2015.