Effect of Istradefylline Treatment on Behavioral Measures of Apathy in Parkinson's Disease.

NCT05182151 | Terminated DMC FDA Drug

• 1 other identifier: Pro00108116
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

Apathy is defined as a lack of feeling, emotion, interest, or concern. Apathy also involves reduction or loss of motivation and goal-directed behavior. Clinically significant apathy, where meaningful activities are given up and quality of life is diminished, is common in people with Parkinson's disease (PD). Many individuals with Parkinson's disease experiencing fluctuations in the severity of their movement problems and medication "off" time. "Off" time refers to periods of the day between doses of PD medication when your motor symptoms (e.g., tremor, stiffness, slowness, walking problems, etc.) are worse and interfere with your ability to complete tasks of daily living. The investigational drug, Istradefylline, is an FDA-approved medication to treat motor fluctuations and "off" time in PD. The purpose of this study is to investigate whether people with Parkinson's disease (PD) who are treated with istradefylline (ISD) show improvements in motivation and apathy over a 12-week period. Specifically, we wish to see whether people with PD who are treated with ISD engage in more physical and recreational activities, such as hobbies and other interests.

Conditions

Apathy; Parkinson Disease

Keywords

istradefylline

Outcome Measures

Primary Outcomes (1)

• Physical Activity Scale for the Elderly (PASE)

  telephone survey

  12 weeks

Secondary Outcomes (7)

• Engagement in Meaningful Activities Survey (EMAS)

  12 weeks

• Lille Apathy Rating Scale (LARS)

  12 weeks

• Apathy Evaluation Scale (AES)

  12 weeks

• Beck Depression Inventory (BDI-2)

  12 weeks

• Epworth Sleepiness Scale (ESS)

  12 weeks

Study Arms (1)

Patient

istradefylline 40mg daily over 12 week period

Drug: Istradefylline 40 mg

Interventions

Istradefylline 40 mg DRUG

adenosine A2A receptor antagonist

Patient

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with dopaminergic therapy for idiopathic Parkinson's disease who have clinically significant motor fluctuations or "off" time warranting adjuvant treatment with ISD.

You may qualify if:

• Diagnosis of PD consistent with United Kingdom Brain Bank Criteria or the Movement Disorder Society Research Criteria for the Diagnosis of Parkinson's Disease, with bradykinesia and sequence effect being present, and prominent motor asymmetry (if no rest tremor).
• Current treatment with levodopa.
• Stable on levodopa and other study-approved medications for PD motor symptoms for at least four weeks prior to screening.
• Clinically significant wearing-off / fluctuating symptomatology warranting treatment with ISD
• Presence of apathy at baseline (LARS \> -22)
• Living with adult informant

You may not qualify if:

• Current or prior treatment with istradefylline. 2. History of Deep Brain Stimulation (DBS) surgery, ablative surgery (e.g., pallidotomy, thalamotomy, focused ultrasound, etc.), Duopa pump implantation, or other invasive intervention for Parkinson's disease symptoms. 3. Injury or concomitant health condition at screening that would preclude engagement in light physical activity. 10 4. Prior history of cerebrovascular accident (e.g., stroke or aneurysm) or seizure disorder (other than febrile seizures during childhood). 5. Dementia (MoCA\<22) 6. Psychotic symptoms that would raise concern for safe use of ISD, as indicated by domains A (delusions) and B (hallucinations) of the Neuropsychiatric Inventory (NPI), and defined as a score of ≥4 on either the A (frequency × severity) or B (frequency × severity) scales of the NPI. 7. Depressive mood symptoms at baseline likely to interfere with response to treatment (BDI-II\>19) 8. Active suicidal ideation within 1 year prior to Screening Visit as determined by a positive response to Question 4 or 5 on the C-SSRS. 9. Diagnosis or treatment for any central nervous system disorder other than Parkinson's disease that could be expected in the eyes of the investigator to impact ability to participate in study. 10. Contraindications / conditions that would preclude safe dosing of 40mg ISD 11. Change in medications for mood or anxiety within 6 weeks of enrollment or anticipation of change in medications for mood or anxiety during the 8-week study period. 12. Moderate or severe hepatic impairment. 13. Current treatment with strong CYP3A4 inhibitors 14. Current treatment with strong CYP3A4 inducers 15. Pregnant women are not able to participate due to unknown safety risks associated with ISD

Sponsors & Collaborators

• Kyowa Kirin, Inc.: collaborator
• Medical University of South Carolina: lead

Study Sites (1)

MUSC Movement Disorders Program

Charleston, South Carolina, 29425, United States

Location

MeSH Terms

Conditions

Lethargy; Parkinson Disease

Interventions

istradefylline

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Lilia Lovera, MD

  Medical University of South Carolina

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 20, 2021
• First Posted: January 10, 2022
• Study Start: July 29, 2022
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)