Parkinson DiseasePhase 1NCT04249544
Social Decision Making in Parkinson's Disease
A Phase 1 study testing Pramipexole in people with Parkinson Disease, run by Vanderbilt University Medical Center at 1 site in United States.
Trial summary
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD… Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Pramipexole
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Dec 2019to 1 Sep 2022
- Phase
- Phase 1
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 45-80
- Ability to give informed consent
- Idiopathic Parkinson's disease
- Currently taking dopamine agonist therapy
- Mild symptom severity (Hoehn \& Yahr ≤ 3)
- Disease duration of <12 years
- Demonstrated positive response to dopamine therapy
Who cannot join
- Medications classes that influence GABA concentrations: benzodiazepines, cholinesterase inhibitors, antipsychotics, opioids, and MAO inhibitors
- History of substance abuse or use of any psychostimulants (other than caffeine) in the last 6 months or more than 4 times in lifetime
- Current tobacco (or nicotine use) or alcohol intake greater than 8 ounces of whiskey or equivalent per week
- Comorbid neurological disorders (e.g., stroke, peripheral neuropathy, seizure disorder) or history of head trauma (other than a single concussion)
- Unstable medical condition, [e.g., diabetes or pulmonary disease, significant medical condition, including high blood pressure (systolic B.P. > 135, Diastolic B.P. > 85), or any hepatic, renal, cardiovascular, hematological, endocrine or ophthalmological condition]
- History of major psychiatric illness (including any affective disorder, substance use disorder, psychotic disorder, or eating disorder)
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- Dementia
- Deep brain stimulation
- Contraindications to 3 Tesla MRI, e.g., extreme obesity, claustrophobia, cochlear implant, metal fragments in eyes, cardiac pacemaker, neural stimulator, tattoos with iron pigment and metallic body inclusions or other metal implanted in the body
- Dyskinesia or tremor that would cause severe motion artifact during MRI scan
- Clear indication of secondary gain
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt University Medical Center
Nashville, Tennessee, 37212
About this study
Official title: Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinsons Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Pramipexole. For the off-DAA visit, participants will receive a placebo. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.
Read the detailed description
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications to reduce circulating drugs and residual drug effects. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinson's Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take 1mg of Pramipexole 1 hour before the scan. For the off-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take a placebo 1 hour before the scan. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.
- Conditions
- Parkinson Disease
- Being tested
- Pramipexole, Placebo
- Keywords
- Impulsive behavior, Social decision making, Moral decision making, dopamine agonists
- Medical subject headings
- Parkinson Disease, Impulsive Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PramipexoleDrug
1mg of pramipexole
PlaceboDrug
1mg equivalent of placebo
| Study group | Role | What they receive |
|---|---|---|
| Impulsive group, placebo then pramipexole | Experimental | half of the impulsive group will first get the placebo on the first day and pramipexole on the second day Receives: Drug: Pramipexole; Drug: Placebo |
| Impulsive group, pramipexole then placebo | Experimental | half of the impulsive group will first get the pramipexole on the first day and the placebo on the second day Receives: Drug: Pramipexole; Drug: Placebo |
| Non-impulsive group, placebo then pramipexole | Experimental | half of the non-impulsive group will first get the placebo on the first day and the pramipexole on the second day Receives: Drug: Pramipexole; Drug: Placebo |
| Non-impulsive, pramipexole then placebo | Experimental | half of the non-impulsive group will first get the pramipexole on the first day and the placebo on the second day Receives: Drug: Pramipexole; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in a harm aversion cognitive moral decision-making task
change in harm aversion from off drug visit to on drug visit
Measured: two weeks
change in blood flow in the ventral striatum per ASL images
change in CBF from off drug visit to on drug visit
Measured: two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2020
- Study start3 Dec 2019
- Primary completion1 Jun 2022
- Study completion1 Sep 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Principal investigator, Richard Darby, Vanderbilt University Medical Center
- Investigators
- Richard R Darby, M.D., Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04249544
- Sponsor's protocol ID
- Social Decision Making in PD
- Other IDs
- W81XWH-19-1-0782
- Status last verified
- Oct 2023
- First submitted
- 28 Jan 2020
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Neural Mechanisms of Impaired Social Decision-Making in Parkinson's Patients Taking Dopamine Agonists
- ClinicalTrials.gov ID
- NCT04249544
- Acronym / sponsor ID
- Social Decision Making in PD
- Conditions
- Parkinson Disease
- Keywords
- Impulsive behavior, Social decision making, Moral decision making, dopamine agonists
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Sep 2022 (actual)
- First posted
- 31 Jan 2020 (actual)
- 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.
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinsons Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Pramipexole. For the off-DAA visit, participants will receive a placebo. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.
Detailed description
Impulsive and compulsive behaviors occur in up to 46% of Parkinson's Disease (PD) patients taking dopamine agonist (DAA) medications. While these abnormal social behaviors have been studied in other neurodegenerative disorders, the true incidence of social problems, and the relationship to dopamine therapy, in PD patients remains unknown. This study is aiming to determine if dopamine agonists alter social decision-making and to determine if impaired social decision-making relates to dopamine-induced mesolimbic network dysfunction in PD patients. The protocol will include a screening visit, and on-DAA visit, and an off-DAA visit. For both the on and off DAA visits, participants will continue taking Carbidopa-Levodopa, but will withdrawal off of other PD related medications to reduce circulating drugs and residual drug effects. Both visits will include an MRI, fMRI shock task, questionnaires to be filled out by other the participant and the caregiver, moral-decision making computer tasks, and the Unified Parkinson's Disease Rating Scale (UPDRS) part II and III. For the on-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take 1mg of Pramipexole 1 hour before the scan. For the off-DAA visit, participants will take Carbidopa-Levodopa 1 hour before the scan and will take a placebo 1 hour before the scan. Participants will remind blinded to which medication they are receiving that day and will be counterbalanced such that all participants will not take the Pramipexole or placebo on the same days.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Impulsive group, placebo then pramipexole | Experimental | Drug: Pramipexole, Drug: Placebohalf of the impulsive group will first get the placebo on the first day and pramipexole on the second day |
| Impulsive group, pramipexole then placebo | Experimental | Drug: Pramipexole, Drug: Placebohalf of the impulsive group will first get the pramipexole on the first day and the placebo on the second day |
| Non-impulsive group, placebo then pramipexole | Experimental | Drug: Pramipexole, Drug: Placebohalf of the non-impulsive group will first get the placebo on the first day and the pramipexole on the second day |
| Non-impulsive, pramipexole then placebo | Experimental | Drug: Pramipexole, Drug: Placebohalf of the non-impulsive group will first get the pramipexole on the first day and the placebo on the second day |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 45-80
- Ability to give informed consent
- Idiopathic Parkinson's disease
- Currently taking dopamine agonist therapy
- Mild symptom severity (Hoehn \& Yahr ≤ 3)
Key exclusion criteria (11 listed)
- Medications classes that influence GABA concentrations: benzodiazepines, cholinesterase inhibitors, antipsychotics, opioids, and MAO inhibitors
- History of substance abuse or use of any psychostimulants (other than caffeine) in the last 6 months or more than 4 times in lifetime
- Current tobacco (or nicotine use) or alcohol intake greater than 8 ounces of whiskey or equivalent per week
- Comorbid neurological disorders (e.g., stroke, peripheral neuropathy, seizure disorder) or history of head trauma (other than a single concussion)
- Unstable medical condition, [e.g., diabetes or pulmonary disease, significant medical condition, including high blood pressure (systolic B.P. > 135, Diastolic B.P. > 85), or any hepatic, renal, cardiovascular, hematological, endocrine or ophthalmological condition]
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 |
|---|---|---|
| Pramipexole1mg of pramipexole | Drug | Impulsive group, placebo then pramipexole, Impulsive group, pramipexole then placebo, Non-impulsive group, placebo then pramipexole, Non-impulsive, pramipexole then placebo |
| Placebo1mg equivalent of placebo | Drug | Impulsive group, placebo then pramipexole, Impulsive group, pramipexole then placebo, Non-impulsive group, placebo then pramipexole, Non-impulsive, pramipexole then placebo |
Primary outcome
The change in a harm aversion cognitive moral decision-making task
Time frame: two weeks
change in harm aversion from off drug visit to on drug visit
change in blood flow in the ventral striatum per ASL images
Time frame: two weeks
change in CBF from off drug visit to on drug visit
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 18 Oct 2023.
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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.
Richard R Darby, M.D. principal investigator
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pramipexole in people with Parkinson Disease, run by Vanderbilt University Medical Center 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 11 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 18 Oct 2023. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The change in a harm aversion cognitive moral decision-making task (time frame: two weeks). The study lists 2 primary outcomes in all. 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 18 Oct 2023.