2026-02-26
notable
Recruiting→Active, Not Recruiting Study Identification, Study Status, Contacts/Locations, References v6
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-11-01→2026-03-10
Completion date2025-11-01→2026-03-10
Study sitesdetails revised at 1 of 1 site
Publicationsdetails revised at 78 of 78 entries
2024-11-22
minor
Study Identification, Study Status, Contacts/Locations, References v5
Study sitescontacts updated at 1 of 1 site
Publicationsdetails revised at 78 of 78 entries
2023-10-04
minor
Study Status, Outcome Measures, Eligibility, Contacts/Locations v4
Secondary endpointsdetails revised at 2 of 4 entries
2022-08-23
minor
Study Status, Sponsor/Collaborators v3
Re-verified, no change to tracked fields
2022-08-16
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v2
Trial statusNot Yet Recruiting→Recruiting
Start date2021-11-23→2022-09-23
Study sites0→1
2021-11-22
minor
Study Status, Study Description, Arms and Interventions, Outcome Measures, Eligibility v1
Start date2021-11-01→2021-11-23
Eligibility criteria+215 characters
[...] ive
Concurrent dementia defined by a score lower than 22 on theThe Montreal Cognitive Assessment (MoCA)
Concurrent severe depression defined by a Beck Depression Inventory-Fast Screen (BDI fast screen) score greater than 13
Comorbidities related to sympathetic nervous system (SNS) hyperactivity
Heart failure (LVEF <45%)
Recent myocardial revascularization (<12 weeks)
Hypertension (systolic blood pressure SBP>150mmHg (millimeters of mercury) or diastolic blood pressure DBP>100mmHg)
Chronic Atrial fibrillation
Concurrent Use of Beta-adrenergic antagonist
Diabetes mellitus
Chronic Obstructive Pul [...] [...]
Secondary endpoints4 entries, revised
Heart Rate Variability Analysis (HRV) compared to MIBG results in predicting RBD convertionconversion to PD/other synucleinopathies
Primary endpoints1 to 3 entries
Changes in 123I-MIBG - Washout ratio (WR)
Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M)
Changes in 123I-MIBG reuptake - late Heart to Mediastinal ratio (H/M)
Study description+109 characters
[...] ive post-synaptic a1-adrenergic blocker terazosin on serial 123 Ioflupane Dopamine Transporter single-photon emission-computed tomography (123I-FP-CIT DAT-SPECT) in a population of subjects with defined pre-motor PD risks [...] tion, depression and color vision abnormality) and abnormal Iodine-123 meta-iodobenzylguanidine (123I-MIBG) uptake.
Imaging changes will be correlated to the presence [...] cardiac autonomic function tests.
The rate of RBD clinical phenoconversionconversion to PD will be estimated and compared to available data in the literature.
2021-10-26
minor
Original filing