Social Decision Making in Parkinson's Disease

NCT04249544 | Completed Phase 1 FDA Drug

• 2 other identifiers: Social Decision Making in PDW81XWH-19-1-0782
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Parkinson Disease

Keywords

Impulsive behavior; Social decision making; Moral decision making; dopamine agonists

Outcome Measures

Primary Outcomes (2)

• The change in a harm aversion cognitive moral decision-making task

  change in harm aversion from off drug visit to on drug visit

  two weeks

• change in blood flow in the ventral striatum per ASL images

  change in CBF from off drug visit to on drug visit

  two weeks

Study Arms (4)

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

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

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

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

Drug: Pramipexole; Drug: Placebo

Interventions

Pramipexole DRUG

1mg of pramipexole

Impulsive group, placebo then pramipexole; Impulsive group, pramipexole then placebo; Non-impulsive group, placebo then pramipexole; Non-impulsive, pramipexole then placebo

Placebo DRUG

1mg equivalent of placebo

Impulsive group, placebo then pramipexole; Impulsive group, pramipexole then placebo; Non-impulsive group, placebo then pramipexole; Non-impulsive, pramipexole then placebo

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)
• Dementia
• Deep brain stimulation
• Dyskinesia or tremor that would cause severe motion artifact during MRI scan
• Clear indication of secondary gain

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• United States Department of Defense: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

MeSH Terms

Conditions

Parkinson Disease; Impulsive Behavior

Interventions

Pramipexole

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Benzothiazoles; Thiazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Richard R Darby, M.D.

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Neurology

Study Record Dates

• First Submitted: January 28, 2020
• First Posted: January 31, 2020
• Study Start: December 3, 2019
• Primary Completion: June 1, 2022
• Study Completion: September 1, 2022
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

US (1)