Trial · NCT04218968
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 16 of 16
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in 123I-Ioflupane uptake - DATscan | Every year for three years | Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three. |
| Secondary | Diagnosis of PD or other synucleinopathies by the end of 3 years in the study population | Every year for 3 years | Clinical evaluation |
| Secondary | Changes in 123I-MIBG late H/M | Every 6 months for 3 years | Changes in 123I-MIBG reuptake, as measured by late H/M ratio, between baseline and every six months for three years |
| Secondary | Changes in 123I-MIBG WR rate | Every 6 months for 3 years | Changes in 123I-MIBG WR reuptake, as measured by WR rate, between baseline and every six months for three years |
| Secondary | Sensitivity and specificity of DAT Scan compared to MIBG in predicting RBD conversion to PD/other synucleinopathies | Every year for3 years | Changes in 123I-Ioflupane uptake, as measured by specific binding ratio (SBR), between baseline, year one, year two and year three. |
| Other | MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III | Every 6 months for 3 years | MDS-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III changes from OFF medication between baseline and every 6 months for three years |
| Other | Non-Motor Symptoms Scale (NMSS) changes | Every 6 months for 3 years | Non-Motor Symptoms Scale (NMSS) changes between baseline and every 6 months for three years |
| Other | Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) | Every 6 months for 3 years | Scales for Outcomes in Parkinson's Disease - Autonomic Dysfunction (SCOPA-AUT) changes between baseline and every 6 months for three years |
| Other | REM sleep Behavior Disorder Screening questionnaire (RBDSQ) | Every 6 months for 3 years | REM sleep Behavior Disorder Screening questionnaire (RBDSQ) changes between baseline and every 6 months for three years |
| Other | University of Pennsylvania Smell Identification Test (UPSIT) | Every 6 months for 3 years | University of Pennsylvania Smell Identification Test (UPSIT) changes between baseline and every 6 months for three years |
| Other | Functional constipation score changes | Every 6 months for 3 years | Functional constipation score changes between baseline and every 6 months for three years. The total score has a range of 0 to 12, with scores \> 4 identifying functional constipation |
| Other | Color vision changes | Every 6 months for 3 years | Color vision changes, as assessed using HRR Pseudoisochromatic Plates, between baseline and every 6 months for three years |
| Other | Central and peripheral insulin resistance changes | Every 6 months for 3 years | Peripheral Insulin Resistance (IR) will be defined by testing for fasting plasma insulin (FPI), fasting plasma glucose (FPG) and glycated hemoglobin (HbA1c). HOMA index will be calculated by the formula: HOMA-IR = (FPI x FPG)/405 . A cutoff HOMA index of 2.0, equivalent to \<50% sensitivity, will be used to define IR. Subjects were considered to have IR if they either had a HOMA≥2.0 and/or HbA1c≥5.7 . In addition, measures of insulin sensitivity in neuronal-origin enriched plasma EVs (central IR) will be used to test the association of changes in such sensitivity to changes in MIBG uptake and clinical scores from baseline and every 6 months. For that purpose, plasma samples will be collected and stored and -80oC 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 cathecolamine metabolism in LC and 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 every 6 months for 3 years |
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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