advanced PD
Conditions
Interventions
Levodopa Acute Challenge Test (LACT)and MRI-MRS Following a 12-Hour Medication-Free Period.
Sponsors
Nishikawa Noriko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Age between 20 and 80 years, inclusive (both males and females are eligible) -Diagnosis of advanced-stage Parkinson's disease (PD) -Considered appropriate candidates for device-aided therapy (DAT) -Regular follow-up at the Department of Neurology, Juntendo University Hospital outpatient clinic (at least once every 8 weeks for a minimum of 24 weeks) -Adequate activities of daily living (ADL) to manage the treatment device independently, or availability of a caregiver to provide support -Provision of written informed consent to participate in the study -Demonstrated responsiveness to levodopa, defined as >=30% improvement in MDS-UPDRS Part III score during a levodopa challenge test
Exclusion criteria
Exclusion criteria: -Presence of severe psychosis-like symptoms, or severe hepatic or renal dysfunction -Significant dermatological issues or surgical scars in the abdominal area -Deemed unsuitable for continued participation in the study by the attending physician -Patients with closed-angle glaucoma or a history of hypersensitivity to any components of LDp/CDp should be excluded, as these contraindications may lead to increased intraocular pressure, worsened symptoms, or allergic reactions
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| he ratio of the threshold plasma concentration of Levodopa for dyskinesia onset between baseline and 24 weeks in the Acute Levodopa Challenge Test (ALCT). | — |
Secondary
| Measure | Time frame |
|---|---|
| -For evaluate LDR, the change in off state MDS-UPDRS Part III scores after the overnight off phase between baseline at both 12 and 24 weeks. This endpoint aims to assess changes in sustained motor response over the course of 12 and 24 weeks, capturing both early and longer-term effects of the treatment. -The change rate in the threshold of plasma Levodopa concentration for dyskinesia onset in ALCT between baseline and 12 weeks. -The severity of dyskinesia difference in MDS-UPDRS Part IV, the Clinical Global Impressions Scale (CGII) and the Unified Dyskinesia Rating Scale (UDysRS) between baseline, 12and 24 weeks after. --CGI-I is assessed at 12 weeks and 24 weeks-- -The change in motor performance, as measured by the difference in MDS-UPDRS Part III scores from the best on scores to the overnight off scores, between baseline, 12 weeks, and 24 weeks in the Acute Levodopa Challenge Test (ALCT). This endpoint evaluates the immediate effect of treatment on motor performance following levodopa administration. | — |
Contacts
Public ContactNoriko Nishikawa
Juntendo University Hospital
Outcome results
None listed