Parkinson's DiseaseNCT00737217
Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
An observational study of Parkinson's Disease, run by University of Michigan at 1 site in United States.
Trial summary
This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- Behavioral assessment/questionnaire
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Apr 2009
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Parkinson's disease, either with or without memory or concentration difficulties, and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.
Who may be able to join
- PDD: Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD with dementia (MMSE 18-25; n=28; age 50-85 years; M/F) are eligible for the study. Hoehn and Yahr stages I-III.
- PD. Patients with who meet the UKPDSBRC criteria for PD with a MMSE of >25 (n=28; age 50-85 years; M/F). Hoehn and Yahr stages I-III.
- Normal control subjects (n=16) (age 50-85 years; M/F).
- No current or past history of neurologic or psychiatric illness.
Who cannot join
- Any subjects on cholinergic, anti-cholinergic drugs will be excluded from the study.
- Current or past history of neurologic or psychiatric illness.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Functional, Cognitive and Mobility Laboratory
Ann Arbor, Michigan, 48106
About this study
This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that in Alzheimer's dementia (dementia is a disease where persons become forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), may be responsible for some of the memory and behavioral changes. At the present time, the investigators have no clear information on the levels of acetylcholine in the brain of patients with Parkinson's disease who also have memory or behavioral changes.
- Conditions
- Parkinson's Disease
- Being tested
- Behavioral assessment/questionnaire
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral assessment/questionnaireBehavioural
Complete behavioral assessment/questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's disease | Not described Receives: Behavioral: Behavioral assessment/questionnaire | |
| Normal Controls | Not described Receives: Behavioral: Behavioral assessment/questionnaire |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2008 (estimated)
- Study startMar 2006
- Primary completionApr 2009
- Study completionApr 2009
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 of MichiganThe 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
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Responsible party
- Principal investigator, Nicolaas Bohnen, MD, PhD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00737217
- Sponsor's protocol ID
- 2005-0464
- Status last verified
- Jun 2013
- First submitted
- 15 Aug 2008
- Last updated
- 26 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Executive, Activities of Daily Living, and Cholinergic Functions in Parkinson's Disease
- ClinicalTrials.gov ID
- NCT00737217
- Acronym / sponsor ID
- 2005-0464
- Conditions
- Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Michael J. Fox Foundation for Parkinson's Research
- Study start
- Mar 2006
- Primary completion
- Apr 2009 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 18 Aug 2008 (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.
This research study will evaluate functions of memory, thinking, behavior, and daily life activities and how these relate to the measurement of certain chemicals (acetylcholine and dopamine) in the brain using an imaging procedure called positron emission tomography (PET). You may know that in Alzheimer's dementia (dementia is a disease where persons become forgetful and confused), a reduction in the amount of acetylcholine, a "neurotransmitter" substance (a chemical messenger that nerve cells need to communicate with each other), may be responsible for some of the memory and behavioral changes. At the present time, the investigators have no clear information on the levels of acetylcholine in the brain of patients with Parkinson's disease who also have memory or behavioral changes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Parkinson's disease | – | Behavioral: Behavioral assessment/questionnaire |
| Normal Controls | – | Behavioral: Behavioral assessment/questionnaire |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Parkinson's disease, either with or without memory or concentration difficulties, and normal control persons between the ages of 50-85 years are eligible to participate in this study. Participants should be willing and able to comply with study requirements. Normal control persons should not have a history of brain or mental disorders. Both males and females are eligible.
Key inclusion criteria (4 listed)
- PDD: Patients who meet the UK Parkinson's Disease Society Brain Bank Research Center (UKPDSBRC) clinical diagnostic criteria for PD with dementia (MMSE 18-25; n=28; age 50-85 years; M/F) are eligible for the study. Hoehn and Yahr stages I-III.
- PD. Patients with who meet the UKPDSBRC criteria for PD with a MMSE of >25 (n=28; age 50-85 years; M/F). Hoehn and Yahr stages I-III.
- Normal control subjects (n=16) (age 50-85 years; M/F).
- No current or past history of neurologic or psychiatric illness.
Key exclusion criteria (2 listed)
- Any subjects on cholinergic, anti-cholinergic drugs will be excluded from the study.
- Current or past history of neurologic or psychiatric illness.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral assessment/questionnaireComplete behavioral assessment/questionnaire | Behavioural | Normal Controls, Parkinson's disease |
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 26 Jun 2013.
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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 University of Michigan 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 4 inclusion and 2 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 26 Jun 2013. 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 26 Jun 2013.