Parkinson DiseaseNCT00094601
Relationship of Dopamine to Cognitive Function in Parkinson's Disease
An observational study of Parkinson Disease, run by National Institute of Mental Health (NIMH) at 1 site in United States.
Trial summary
This study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects. Read more about this study
- Who is it for?
- Ages 40 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Parkinson Disease
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2004to 22 Jan 2008
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- PD patients must meet the diagnosis of idiopathic Parkinson's disease. Diagnosis will be based upon the presence of at least two of the four cardinal symptoms (tremor, bradykinesia, rigidity and instability) as well as a positive response to dopaminergic agents.
- Patients will be on stable dopaminergic therapy for approximately two weeks prior to enrollment.
- Control subjects must be healthy and aged 40 - 85 years and will be age and gender matched to PD patients.
Who cannot join
- Diagnosis of idiopathic Parkinson's disease.
- Secondary cause of Parkinsonism, e.g. Wilson's disease, neuroleptic use.
- Psychiatric disease that would, in judgment of the investigator, interfere with the safe conduct of the study.
- Current psychiatric illness.
- Severe depressive symptoms with BDI 16+.
- Substance abuse, severe systemic disease, poor vision or hearing based on history and physical exam.
Show all 34Show fewer
- Incidence of Parkinson's disease in two or more first degree relatives.
- Dementia not due to PD or severe dementia with MMSE less than 15.
- Neurological disorder other than PD that would effect protocol (e.g. stroke, Alzheimer's disease).
- Laboratory tests with clinically significant abnormalities.
- History of an abnormal MRI.
- Pregnancy or breast feeding.
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual NIH RSC limits.
- Any conditions that increase risk for MRI (pacemaker, metallic foreign body, claustrophobia, etc.).
- Any medical condition that in the opinion of the investigators would interfere with the safe conduct of the study.
- Severe hypertension. The subject may be on anti-hypertensive medications. The initial screening must show no more than moderate hypertension - i.e. less than 160/95. In addition, the subject must have normal laboratory values (e.g., BUN, creatinine, urinalysis, and ECG) to document lack of end organ damage. On baseline evaluation on the day of the scan (i.e., before injection of tracer), the subject must be asymptomatic (no headache, dizziness, neurological symptoms, or blurred vision) AND have sustained BP less than 180/100.
- Inability to provide consent.
- Smoking within 6 months prior to enrollment in the study.
- Secondary cause of Parkinsonism, e.g. Wilson's disease, neuroleptic use.
- Psychiatric disease that would, in judgment of the investigator, interfere with the safe conduct of the study.
- Current psychiatric illness except for depression.
- Severe depressive symptoms with BDI 16+.
- Substance abuse, severe systemic disease, poor vision or hearing based on history and physical exam.
- Dementia not due to PD or severe dementia with MMSE less than 15.
- Neurological disorder other than PD that would effect protocol (e.g. stroke, Alzheimer's disease).
- Laboratory tests with clinically significant abnormalities.
- History of an abnormal MRI.
- Pregnancy or breast feeding.
- Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual NIH RSC limits.
- Any conditions that increase risk for MRI (pacemaker, metallic foreign body, claustrophobia, etc.).
- Any medical condition that in the opinion of the investigators would interfere with the safe conduct of the study.
- Severe hypertension. The subject may be on anti-hypertensive medications. The initial screening must show no more than moderate hypertension - i.e. less than 160/95. In addition, the subject must have normal laboratory values (e.g., BUN, creatinine, urinalysis, and ECG) to document lack of end organ damage. On baseline evaluation on the day of the scan (i.e., before injection of tracer), the subject must be asymptomatic (no headache, dizziness, neurological symptoms, or blurred vision) AND have sustained BP less than 180/100.
- Inability to provide consent.
- Smoking within 6 months prior to enrollment in the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Cognitive Function in Parkinson's Disease: Relationship to Cortical Dopamine Synthesis and Dopamine D1 Receptors
This study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects.
Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years of age may be eligible for this study. Pregnant women with Parkinson's disease and breastfeeding normal volunteers are excluded. Candidates are screened with a physical and neurological examination, blood tests, a brief mental test called the Mini Mental Status Examination, and other tests designed to assess memory, learning, reasoning, and other thought processes. Patients with Parkinson's disease also undergo a more thorough mental evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4 or 5 outpatient visits to NIH.
Read more
Participants undergo two positron emission tomography (PET) scans on two separate days and a magnetic resonance imaging (MRI) scan, as follows:
PET Scans
The two PET procedures are done the same way, except one uses a radioactive tracer called [(18)F]DOPA and one uses a tracer called [(11)C]NNC-112. A catheter (small plastic tube) is placed in a vein in the subject's arm for injection of the tracer. The subject lies on the scanner bed and a special mask is fitted to his or her head to hold it in place during the procedure. Just before injecting the tracer, a 10-minute "transmission scan" is done of the head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers ([(18)F]DOPA or [(11)C]NNC-112 are done for about 90 minutes. About 1 hour before injection of the [(18)F]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the tracer work properly. Blood pressure, breathing and heart are monitored before and after injection of the [(11)C]NNC-112 tracer.
Patients with Parkinson's disease are taken off all Parkinson's medications the night before the [(18)F]DOPA scan and their motor function is tested the following morning before the scans are done, using the Unified Parkinson's Disease Rating Scale. Patients can resume all medications except L-DOPA (including Sinemet) after the movement test, and they can resume L-DOPA after the PET scan is finished.
MRI Scan
MRI uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies still on a table that slides inside the scanner, a metal cylinder. They wear ear plugs to muffle loud knocking sounds that occur during the scanning and can communicate with the MRI staff at any time through an intercom.
Read the detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder, particularly in the elderly population. PD is characterized primarily by motor impairment, but cognitive impairment is common and dementia may occur in about 30% of patients. The pathological hallmark of PD is the selective degeneration of nigrostriatal dopamine neurons and the appearance of intracytoplasmic inclusions known as Lewy Bodies. Dopaminergic dysfunction has been widely demonstrated in PD patients. Reductions in [18F]FDOPA uptake has been consistently observed in PD, although it remains to be established whether there are relative differences between PD with and without dementia, and its association with cognitive function. Furthermore, data relating to dopamine D1 receptors in PD are limited to post mortem studies and imaging with the D1 tracer [11C]SCH 23390, and little is known about the role of D1 receptors in vivo and how it relates to clinical phenomena. The aim of the current study is to assess the feasibility and usefulness of imaging of the dopamine D1 receptor and dopamine terminal function in vivo, using PET (positron emission tomography) in patients with PD, with and without dementia, and to assess changes in presynaptic and postsynaptic dopaminergic markers in PD. The long-term goal of the present study is to further our understanding of the role of the dopaminergic system in the pathogenesis of PD and its relationship with cognitive and motor deficits of PD. Knowledge gained from the present study may assist in the development of novel therapeutic targets for PD.
- Conditions
- Parkinson Disease
- Keywords
- Positron Emission Tomograhy, [18F] FDOPA, [11C] NNC-112, Dopamine, Molecular Imaging, Dopamine D1 Receptor, PET, Parkinson's Disease, Cognition, Parkinson Disease, PD, Healthy Volunteer, HV
- Medical subject headings
- Parkinson Disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2004 (estimated)
- Study start18 Oct 2004
- Study completion22 Jan 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by National Institute of Mental Health (NIMH)The 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
- Enrolment
- 75 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Mental Health (NIMH)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00094601
- Sponsor's protocol ID
- 050011
- Other IDs
- 05-M-0011
- Status last verified
- 22 Jan 2008
- First submitted
- 20 Oct 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Abi-Dargham A, Mawlawi O, Lombardo I, Gil R, Martinez D, Huang Y, Hwang DR, Keilp J, Kochan L, Van Heertum R, Gorman JM, Laruelle M. Prefrontal dopamine D1 receptors and working memory in schizophrenia. J Neurosci. 2002 May 1;22(9):3708-19. doi: 10.1523/JNEUROSCI.22-09-03708.2002.
PubMed 11978847
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Function in Parkinson's Disease: Relationship to Cortical Dopamine Synthesis and Dopamine D1 Receptors
- ClinicalTrials.gov ID
- NCT00094601
- Acronym / sponsor ID
- 050011
- Conditions
- Parkinson Disease
- Keywords
- Positron Emission Tomograhy, [18F] FDOPA, [11C] NNC-112, Dopamine, Molecular Imaging, Dopamine D1 Receptor, PET, Parkinson's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 75 participants
- Lead sponsor
- National Institute of Mental Health (NIMH)US National Institutes of Health
- Study start
- 18 Oct 2004
- Study completion
- 22 Jan 2008
- First posted
- 21 Oct 2004 (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 study will examine how the brain chemical dopamine affects memory, reasoning, and other thought processes in people with Parkinson's disease with and without dementia and in healthy control subjects.
Healthy normal volunteers and people with Parkinson's disease who are between 40 and 85 years of age may be eligible for this study. Pregnant women with Parkinson's disease and breastfeeding normal volunteers are excluded. Candidates are screened with a physical and neurological examination, blood tests, a brief mental test called the Mini Mental Status Examination, and other tests designed to assess memory, learning, reasoning, and other thought processes. Patients with Parkinson's disease also undergo a more thorough mental evaluation called the Mattis Dementia Rating Scale. The study requires about 15 hours over 4 or 5 outpatient visits to NIH.
Participants undergo two positron emission tomography (PET) scans on two separate days and a magnetic resonance imaging (MRI) scan, as follows:
PET Scans
The two PET procedures are done the same way, except one uses a radioactive tracer called [(18)F]DOPA and one uses a tracer called [(11)C]NNC-112. A catheter (small plastic tube) is placed in a vein in the subject's arm for injection of the tracer. The subject lies on the scanner bed and a special mask is fitted to his or her head to hold it in place during the procedure. Just before injecting the tracer, a 10-minute "transmission scan" is done of the head using a tracer called (68)Ge. Then, a series of scans using one of the two study tracers ([(18)F]DOPA or [(11)C]NNC-112 are done for about 90 minutes. About 1 hour before injection of the [(18)F]DOPA tracer, subjects take 200 mg of the drug carbidopa by mouth to help the tracer work properly. Blood pressure, breathing and heart are monitored before and after injection of the [(11)C]NNC-112 tracer.
Patients with Parkinson's disease are taken off all Parkinson's medications the night before the [(18)F]DOPA scan and their motor function is tested the following morning before the scans are done, using the Unified Parkinson's Disease Rating Scale. Patients can resume all medications except L-DOPA (including Sinemet) after the movement test, and they can resume L-DOPA after the PET scan is finished.
MRI Scan
MRI uses a strong magnetic field and radio waves to obtain images of the brain. The subject lies still on a table that slides inside the scanner, a metal cylinder. They wear ear plugs to muffle loud knocking sounds that occur during the scanning and can communicate with the MRI staff at any time through an intercom.
Detailed description
Parkinson's disease (PD) is a common neurodegenerative disorder, particularly in the elderly population. PD is characterized primarily by motor impairment, but cognitive impairment is common and dementia may occur in about 30% of patients. The pathological hallmark of PD is the selective degeneration of nigrostriatal dopamine neurons and the appearance of intracytoplasmic inclusions known as Lewy Bodies. Dopaminergic dysfunction has been widely demonstrated in PD patients. Reductions in [18F]FDOPA uptake has been consistently observed in PD, although it remains to be established whether there are relative differences between PD with and without dementia, and its association with cognitive function. Furthermore, data relating to dopamine D1 receptors in PD are limited to post mortem studies and imaging with the D1 tracer [11C]SCH 23390, and little is known about the role of D1 receptors in vivo and how it relates to clinical phenomena. The aim of the current study is to assess the feasibility and usefulness of imaging of the dopamine D1 receptor and dopamine terminal function in vivo, using PET (positron emission tomography) in patients with PD, with and without dementia, and to assess changes in presynaptic and postsynaptic dopaminergic markers in PD. The long-term goal of the present study is to further our understanding of the role of the dopaminergic system in the pathogenesis of PD and its relationship with cognitive and motor deficits of PD. Knowledge gained from the present study may assist in the development of novel therapeutic targets for PD.
Study design
Who may qualify
- Ages
- 40 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- PD patients must meet the diagnosis of idiopathic Parkinson's disease. Diagnosis will be based upon the presence of at least two of the four cardinal symptoms (tremor, bradykinesia, rigidity and instability) as well as a positive response to dopaminergic agents.
- Patients will be on stable dopaminergic therapy for approximately two weeks prior to enrollment.
- Control subjects must be healthy and aged 40 - 85 years and will be age and gender matched to PD patients.
Key exclusion criteria (34 listed)
- Diagnosis of idiopathic Parkinson's disease.
- Secondary cause of Parkinsonism, e.g. Wilson's disease, neuroleptic use.
- Psychiatric disease that would, in judgment of the investigator, interfere with the safe conduct of the study.
- Current psychiatric illness.
- Severe depressive symptoms with BDI 16+.
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 2 Jul 2017.
- Background: PubMed 11978847Abi-Dargham A, Mawlawi O, Lombardo I, Gil R, Martinez D, Huang Y, Hwang DR, Keilp J, Kochan L, Van Heertum R, Gorman JM, Laruelle M. Prefrontal dopamine D1 receptors and working memory in schizophrenia. J Neurosci. 2002 May 1;22(9):3708-19. doi: 10.1523/JNEUROSCI.22-09-03708.2002.
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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 Disease, run by National Institute of Mental Health (NIMH) 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 3 inclusion and 34 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 2 Jul 2017. 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?
On the ClinicalTrials.gov record for NCT00094601, which also lists 1 linked publication.
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 2 Jul 2017.