PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study (FARPRESTO)

March 22, 2024 updated by: Monica Puligheddu, University of Cagliari

Redictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study [FAttori di Rischio PREdittivi di Conversione Nell'RBD Idiopatico. STudio ItalianO

REM Sleep Behavior Disorder (RBD) is a REM sleep parasomnia first described in 1986 and characterized by the loss of physiological muscle atonia typical of REM sleep and by the presence of abnormal, sometimes violent, motor activity often related to dream content The observed motor behaviors are often associated to vivid dreams, characterized by an aggressive-defensive content, even if pleasant dreams have been described, resulting in non-violent behaviors. Diagnosis of RBD requires video-polysomnographic recording (vPSG) at a Sleep Center, essential to identify and quantify the complete or intermittent loss of physiological muscle atonia during REM sleep (REM sleep without atonia, RSWA) and record any related motor behaviors. The exact prevalence of RBD in the general population is not known and it seems underrated, but is estimated to be 0.3-1.15%. RBD is defined as idiopathic or isolated (iRBD) when it is not associated with other neurological diseases. The so-called symptomatic RBD, on the other hand, can occur in association with neurodegenerative diseases of the spectrum of alpha-synucleinopathies which include Parkinson's Disease (PD), Multiple System Atrophy (AMS), and Lewy Body Dementia (DLB). In recent years, several follow-up studies on large cohorts of iRBD patients have shown that the idiopathic form evolves towards a symptomatic form in most cases. More precisely, the risk of developing an alpha-synucleinopathies increases over time, with a conversion rate of up to 90% in some studies at 14 years. RBD represents an early marker of neurodegeneration, like a unique open window on the initial, pre-symptomatic phase of alpha-synucleinopathies, which could allow the use of neuroprotective therapies, as soon as they are available. Several longitudinal studies indicated older age, presence of hyposmia, abnormal color vision, minimal extrapyramidal motor signs, mild cognitive impairment, autonomic disturbances, and severity of loss of RSWA as risk factors for neurodegeneration. However, most studies investigated biomarkers separately, with retrospective study designs, in small cohorts or without a rigorous harmonization between centers in the case of multicenter studies.

To date, however, there is no reliable pool of biomarkers that predict the phenoconversion into α-synucleinopathy, the timing in which this can occur, and the phenotype of α-synucleinopathy. Furthermore, despite clinical and research evidence suggesting that iRBD is a heterogeneous disorder little attention was paid to different iRBD phenotypes and currently, there are no relevant data on the impact of iRBD on quality of life.

Actually, through neural network analysis approaches, it is possible to find out complex correlations between data from different sources (i.e., clinical examinations, questionnaires, biological data, imaging and neurophysiological techniques, etc.) and to identify subgroups of patients sharing the same substantial characteristics. Identifying different iRBD phenotypes through established as well as innovative biomarkers and standardized measures of wellbeing is crucial to better understanding alpha-synucleinopathies, developing targeted interventions, and reducing the disease burden.

To this aim, clinical, biological, neurophysiological, neuropsychological and imaging biomarkers need to be prospectively collected, according to standardized and harmonized procedures. This would significantly increase our understanding of the physiopathological processes of alpha-synucleinopathy from the prodromal phase. Indeed, identifying phenotype clusters with both consolidated and innovative biomarkers may lay the groundwork for a reliable characterization of iRBD patients, likely providing the basis for an efficient stratification of patients longitudinally followed.

Several disease-modifying therapies are now in development, including but not limited to monoclonal antibodies against alpha-synucleinopathy. Prodromal synucleinopathy patients, such as those with iRBD, are the ideal target to test disease-modifying therapies because the neurodegeneration is still in an early stage and the likelihood to rescue both brain structures and function is higher. The last aim of the FarPResto study is to have a trial-ready cohort of iRBD patients, collected with standardized and harmonized procedures, to be enrolled in upcoming disease-modifying trials.

The FARPRESTO project is endorsed by the Italian Association of Sleep Medicine (AIMS) and by The RBD_Patients society (www.sonnomed.it)

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
      • Cagliari, Italy, 09042
        • Recruiting
        • Centro Interdipartimentale di Medicina del Sonno, Università degli studi di Cagliari
        • Contact:
    • Verbania
      • Oggebbio, Verbania, Italy, 28824
        • Recruiting
        • IRCCS Auxologico Piancavallo
        • Contact:
        • Principal Investigator:
          • Riccardo Cremascoli

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients, aged major of 18 years old, diagnosed with iRBD, that can provide informed consent referring to centers participating in the FARPRESTO study

Description

Inclusion Criteria:

  • Age: major of 18 years old
  • iRBD diagnosis, according to diagnostic criteria of the ICSD second and third edition

Exclusion Criteria:

  • Impossibility to provide or withdraw informed consent and inability to read, write and understand the purpose and modality of the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of predictive risk factors of phenoconversion in patients with iRBD
Time Frame: May 25, 2020 - January 31, 2035
In order to increase our understanding on the physiopathological processes of alpha-synucleinopathy from the prodromal phase clinical, biological, neurophysiological, neuropsychological and imaging biomarkers need to be prospectively collected, according to standardized and harmonized procedures. Moreover, identifying phenotype clusters with both consolidated and innovative biomakers may lay the groundwork for a reliable characterization of iRBD patients, likely providing the basis for an efficient stratification of patients to be longitudinally followed.
May 25, 2020 - January 31, 2035

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Description of the socio-demographic and clinical characteristics of patients diagnosed with iRBD
Time Frame: May 25, 2020 - January 31, 2035
Data on socio-demographic and clinical characteristics of patients diagnosed with iRBD will be collected and analyzed.
May 25, 2020 - January 31, 2035
Collection of longitudinal data about the development of alpha-synucleinopathies and estimation of the conversion rate at 3, 5, 7, and 10 years
Time Frame: May 25, 2020 - January 31, 2035
Information about the conversion rate at 3, 5, 7, and 10 years to neurodegenerative pathologies of the spectrum of alpha-synucleinopathies (Parkinson's Disease, Multiple System Atrophy and Lewy Body Dementia) will be collected and evaluated.
May 25, 2020 - January 31, 2035
Evaluation of the impact of iRBD on the quality of life and sleep
Time Frame: May 25, 2020 - January 31, 2035
The impact of iRBD on the quality of life and sleep will be assessed through the administration of validated questionnaires.
May 25, 2020 - January 31, 2035
Assessment of the correlation between phenoconversion, cognitive performance and loss of normal muscle atony during REM sleep
Time Frame: May 25, 2020 - January 31, 2035
The results of cognitive performance tests, video-polysomnographic recording and their connection with phenoconversion will be investigated
May 25, 2020 - January 31, 2035
Identification of RBD phenotypes through different biomarkers
Time Frame: May 25, 2020 - January 31, 2035
RBD phenotypes will be identified evaluating clinical, biological,neurophysiological, neuropsychological and imaging biomarkers.
May 25, 2020 - January 31, 2035
Validation of vPSG criteria for RBD diagnosis
Time Frame: May 25, 2020 - January 31, 2035
vPSG criteria for RBD diagnosis will be validated
May 25, 2020 - January 31, 2035

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Cagliari

Collaborators

University of Bologna
University of Pavia
Istituto Auxologico Italiano
University of Genova

Investigators

  • Principal Investigator: Monica Puligheddu, MD,PhD, University of Cagliari

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 25, 2020

Primary Completion (Estimated)

March 31, 2025

Study Completion (Estimated)

January 31, 2035

Study Registration Dates

First Submitted

February 21, 2022

First Submitted That Met QC Criteria

February 21, 2022

First Posted (Actual)

March 2, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FarPresto01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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