A Phase 1 interventional study of Pramipexole and Placebo in Parkinson Disease, sponsored by Vanderbilt University Medical Center. Completed at 1 site in United States. Open to participants aged 45 Years to 80 Years. Per ClinicalTrials.gov, last updated 2023-10-18.
Sponsored by Vanderbilt University Medical Center · Phase 1, Interventional, and Basic science
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's enrollment of 18 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.
Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.
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Exclusion Criteria:
half of the impulsive group will first get the placebo on the first day and pramipexole on the second day
Drug: Pramipexole · Drug: Placebo
half of the impulsive group will first get the pramipexole on the first day and the placebo on the second day
Drug: Pramipexole · Drug: Placebo
half of the non-impulsive group will first get the placebo on the first day and the pramipexole on the second day
Drug: Pramipexole · Drug: Placebo
half of the non-impulsive group will first get the pramipexole on the first day and the placebo on the second day
Drug: Pramipexole · Drug: Placebo
1mg of pramipexole
1mg equivalent of placebo
The change in a harm aversion cognitive moral decision-making task
change in harm aversion from off drug visit to on drug visit
Time frame: two weeks
change in blood flow in the ventral striatum per ASL images
change in CBF from off drug visit to on drug visit
Time frame: two weeks
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Vanderbilt University Medical Center