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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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27 February 2023 |
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Main ID: |
NCT05721911 |
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Date of registration:
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30/01/2023 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Implementing a National Biobank of PD With WGS and Functional Assessment of Polygenic Inheritance by iPSC Technology
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Scientific title:
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Implementing a National Biobank of Genetic, Sporadic and Prodromic Parkinson's Disease With Whole Genome Analysis and Functional Assessment of Polygenic Inheritance by iPSC Technology |
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Date of first enrolment:
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June 2023 |
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Target sample size:
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230 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT05721911 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Italy
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Contacts
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Name:
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Teresa Esposito, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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IRCCS INM Neuromed |
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Name:
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Teresa Esposito, PhD |
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Address:
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Telephone:
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+39 0865915249 |
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Email:
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teresa.esposito@igb.cnr.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria PD patients:
- Presence of at least 2 of the 4 cardinal signs (tremor, rigidity, bradykinesia, onset
asymmetric) one of which must be tremor or bradykinesia;
- Absence of atypical symptoms such as: i) early postural instability, freezing
phenomena, cognitive impairment, hallucinations, pathological involuntary movements,
vertical gaze paralysis; ii) confirmed causes of secondary parkinsonism (focal
lesions, drugs, substances toxic);
- Documented response to L-dopa or dopamine agonist use (or lack of adequate therapeutic
attempt with L-dopa or dopamine agonists).
Inclusion Criteria RBD patients:
• Subjects affected by idiopathic RBD that will be selected according to the most recent
criteria international classification of sleep disorders (ICSD-3).
Exclusion Criteria:
- pre-existing psychiatric conditions;
- Neurodegenerative neurological diseases such as multiple sclerosis, lateral sclerosis
amyotrophic, Alzheimer's, neuromuscular pathologies, epilepsy;
- diagnosis of dementia;
- depression;
- prolonged intake of anxiolytics, antidepressants, antipsychotics, hypnotic drugs,
cognitive stimulants
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Parkinson Disease
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REM Sleep Behavior Disorder
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Intervention(s)
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Genetic: whole genome sequencing
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Primary Outcome(s)
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clinical evaluation of of sleep disorders in PD and RBD patients
[Time Frame: 2 years]
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clinical evaluation of levodopa-induced dyskinesia (LID) in PD patients
[Time Frame: 2 years]
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clinical evaluation of of sleep disorders in PD and RBD patients by Polysomnography
[Time Frame: 2 years]
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association with phenotypic manifestation of PD
[Time Frame: 2 years]
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clinical evaluation of cognitive impairment of PD and RBD patients by MoCA test score
[Time Frame: 2 years]
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motor symptoms of PD and RBD patients will be evaluated with Hoehn and Yahr (HY) score
[Time Frame: 2 years]
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identification of variants/mutations
[Time Frame: 2 years]
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motor and non motor symptoms of PD and RBD patients will be evaluated with MDS-UPDRS
[Time Frame: 2 years]
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Secondary ID(s)
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PNRR-MAD-2022-12375960
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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