Trial · NCT05109364
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 19 of 19
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in 123I-MIBG reuptake - early Heart to Mediastinal ratio (H/M) | Every 6 months for 3 years | 123I-MIBG early reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the early images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M \<2.2. |
| Primary | Changes in 123I-MIBG reuptake - late Heart to Mediastinal ratio (H/M) | Every 6 months for 3 years | 123I-MIBG late reuptake will be measured by Heart to Mediastinal ratio (H/M) which will be calculated from the late images after drawing regions of interest (7×7 pixels) over the upper mediastinum and circular ROI around the entire heart. MIBG abnormality cutoff will be set for values of late H/M \<2.2. |
| Primary | Changes in 123I-MIBG - Washout ratio (WR) | Every 6 months for 3 years | 123I-MIBG Washout ratio (WR) will be calculated using the following formula: \[(early heart counts/pixel - early mediastinum counts/pixel) - (late heart counts/pixel decay-corrected - late mediastinum counts/pixel decay-corrected)\]/(early heart counts/pixel - early mediastinum counts/pixel). Care will be taken to exclude lung or liver from the myocardial and large vessels and lung from the mediastinum region of interest. MIBG abnormality cutoff will be set for values of WR \>30%. |
| Secondary | Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population | 3 years | Diagnosis of PD will be defined or ruled out according to the United Kingdom Parkinson's Disease Society Brain Bank (UKPDSBB) criteria |
| Secondary | Changes in 123I-Ioflupane uptake | Every year for three years | Measured by 123I-Ioflupane uptake, between baseline, year one, year two and year three. |
| Secondary | Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies | 3 years | Integrity of pigmented neurons of substantia nigra. |
| Secondary | Heart Rate Variability Analysis (HRV) compared to MIBG results in predicting RBD conversion to PD/other synucleinopathies | Every 6 months for 3 years | Beat-to-beat intervals will be registered to assess sympatho-vagal balance. This measurement will be used for HRV analysis. |
| Other | MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III changes from without (OFF) medication between baseline and every 6 months for three years | Every 6 months for 3 years | The Movement disorder society-unified Parkinson's disease rating scale (MDS-UPDRS) Part III will be administered at baseline and 26 weeks after study medication titration. Each item of the MDS-UPDRS has a possible rating from 0 to 4, where 0 = normal, 1 = slight, 2 = mild, 3 = moderate, and 4 = severe.Clinical scales will be performed without (OFF) medication in those subjects that might be receiving dopaminergic drugs |
| Other | Non-Motor Symptoms Scale (NMSS) changes between baseline and every 6 months for three years | Every 6 months for 3 years | The NMSS measures non-motor symptoms over the previous month. Each symptom is scored with respect to: Severity: 0 = None, 1 = Mild; 2 = Moderate; 3 = Severe and Frequency: 1 = Rarely (\<1/wk); 2 = Often (1/wk); 3 = Frequent (several times per week); 4 = Very Frequent (daily or all the time). |
| Other | Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) changes between baseline and every 6 months for three years | Every 6 months for 3 years | The SCOPA-AUT was developed to evaluate autonomic symptoms in patients with Parkinson's disease. The scale is self-completed by patients and consists of 25 items assessing the following domains: gastrointestinal (7), urinary (6), cardiovascular (3), thermoregulatory (4), pupillomotor (1), and sexual (2 items for men and 2 items for women). |
| Other | Rapid Eyes Movement (REM) sleep Behavior Disorder Screening questionnaire (RBDSQ) changes between baseline and every 6 months for three years | Every 6 months for 3 years | The RBDSQ is a 10-item, patient self-rating instrument assessing the subject's sleep behavior with short questions that have to be answered by either "yes" or "no" that address frequency and content of dreams, their relationship to nocturnal movements/behavior, injuries of the bed partner, nocturnal vocalization, etc. The maximum total score of the RBDSQ is 13 points. |
| Other | Smell changes as measured by University of Pennsylvania Smell Identification Test (UPSIT) | Every 6 months for 3 years | University of Pennsylvania Smell Identification Test (UPSIT) changes. |
| Other | Functional constipation score changes between baseline and every 6 months for three years | Every 6 months for 3 years | Functional constipation will be assessed at screening and at 26 weeks after study medication titration using a questionnaire based on modified The Rome III Criteria for Functional Digestive Disorders (ROME III diagnostic criteria), which focuses on symptoms including straining, lumpy or hard stools, sensation of incomplete evacuation, sensation of anorectal obstruction or blockage, manual maneuvers to facilitate evacuation, and two or fewer bowel movements per week. This questionnaire is based on a six item self-report measures with a three point summated rating scale. The total score has a range of 0 to 12, with scores \> 4 identifying functional constipation. |
| Other | Color vision changes, as assessed using Hardy, Rand and Rittler (HRR) pseudoisochromatic Plates, between baseline and every 6 months for three years | Every 6 months for 3 years | Color vision changes will be assessed using HRR pseudoisochromatic Plates. |
| Other | Central insulin resistance changes between baseline and every 6 months for three years | Every 6 months for 3 years | Measures of insulin sensitivity in neuronal-origin enriched plasma extracellular vesicles EVs (central IR) will be used to test the association of changes in such sensitivity to changes in MIBG uptake and clinical scores. For that purpose, plasma samples will be collected and stored and -80oC (celsius degrees) to allow for isolation of neuronal origin EVs at the completion of the study. |
| Other | Differences in integrity of pigmented neurons in the locus coeruleus and substantia nigra between baseline, year one, year two and year three | 3 years | This outcome will be measured by the content of neuromelanin, a product of catecholamine metabolism in locus coeruleus (LC) and substantia nigra (SN). |
| Other | Correlation between changes in integrity of pigmented neurons of substantia nigra as measured by neuromelanin-sensitive magnetic resonance imaging (MRI) and 123I-Ioflupane uptake as measured by Dopamine Transporter Imaging (DAT scan) | 3 years | These measurements will be aggregated to calculate the correlation between changes in neuromelanin content as measured by NM-MRI and dopamine content as measured by DAT scan |
| Other | Heart Rate Variability (HRV) changes between baseline and every 6 months for three years | Every 6 months for 3 years | Beat-to-beat intervals will be registered to assess sympatho-vagal balance. This measurement will be used for HRV analysis. |
| Other | Peripheral insulin resistance (IR) changes between baseline and every 6 months for three years. | Every 6 months for 3 years | Peripheral IR will be defined by the homeostasis model assessment of IR (HOMA-IR) defined as fasting glucose (mmol/L) x fasting insulin (mU/mL)/22.5. A cutoff HOMA index of 2.0, equivalent to \<50% sensitivity, will be used to define IR. Subjects will be considered to have IR if they either have a HOMA≥2.0 and/or HbA1c≥5.7 |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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