REM Sleep Behavior DisorderFARPRESTONCT05262543
PREdictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study
An observational study of REM Sleep Behavior Disorder, run by University of Cagliari at 2 sites in Italy.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- REM Sleep Behavior Disorder
- How many people
- 300 participants
- Where
- 2 sitesItaly
- Study dates
- 25 May 2020to 31 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Age: major of 18 years old
- iRBD diagnosis, according to diagnostic criteria of the ICSD second and third edition
Who cannot join
- Impossibility to provide or withdraw informed consent and inability to read, write and understand the purpose and modality of the study.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Centro Interdipartimentale di Medicina del Sonno, Università degli studi di Cagliari
Cagliari, 09042
Puligheddu, 070 5109 6016, centrosonnoca@unica.it
- Recruiting
IRCCS Auxologico Piancavallo
Oggebbio, Verbania, 28824
Riccardo Cremascoli, r.cremascoli@auxologico.it
Riccardo Cremascoli
About this study
Official title: 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.
Read more
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)
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- atonia, neurodegeneration
- Medical subject headings
- REM Sleep Behavior Disorder, Nerve Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of predictive risk factors of phenoconversion in patients with iRBD
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.
Measured: May 25, 2020 - January 31, 2035
Secondary outcomes (6)
Description of the socio-demographic and clinical characteristics of patients diagnosed with iRBD
Data on socio-demographic and clinical characteristics of patients diagnosed with iRBD will be collected and analyzed.
Measured: 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
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.
Measured: May 25, 2020 - January 31, 2035
Evaluation of the impact of iRBD on the quality of life and sleep
The impact of iRBD on the quality of life and sleep will be assessed through the administration of validated questionnaires.
Measured: May 25, 2020 - January 31, 2035
Assessment of the correlation between phenoconversion, cognitive performance and loss of normal muscle atony during REM sleep
The results of cognitive performance tests, video-polysomnographic recording and their connection with phenoconversion will be investigated
Measured: May 25, 2020 - January 31, 2035
Identification of RBD phenotypes through different biomarkers
RBD phenotypes will be identified evaluating clinical, biological,neurophysiological, neuropsychological and imaging biomarkers.
Measured: May 25, 2020 - January 31, 2035
Validation of vPSG criteria for RBD diagnosis
vPSG criteria for RBD diagnosis will be validated
Measured: May 25, 2020 - January 31, 2035
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start25 May 2020
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for REM Sleep Behavior DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Cagliari
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bologna, University of Genova, University of Pavia, Istituto Auxologico Italiano
- Responsible party
- Principal investigator, Monica Puligheddu, University of Cagliari
- Investigators
- Monica Puligheddu, MD,PhD, Principal investigator, University of Cagliari
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05262543
- Sponsor's protocol ID
- FarPresto01
- Acronym
- FARPRESTO
- Status last verified
- Mar 2024
- First submitted
- 21 Feb 2022
- Last updated
- 26 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fantini ML, Corona A, Clerici S, Ferini-Strambi L. Aggressive dream content without daytime aggressiveness in REM sleep behavior disorder. Neurology. 2005 Oct 11;65(7):1010-5. doi: 10.1212/01.wnl.0000179346.39655.e0.
PubMed 16217051Oudiette D, De Cock VC, Lavault S, Leu S, Vidailhet M, Arnulf I. Nonviolent elaborate behaviors may also occur in REM sleep behavior disorder. Neurology. 2009 Feb 10;72(6):551-7. doi: 10.1212/01.wnl.0000341936.78678.3a.
PubMed 19204265Schenck CH, Mahowald MW. REM sleep behavior disorder: clinical, developmental, and neuroscience perspectives 16 years after its formal identification in SLEEP. Sleep. 2002 Mar 15;25(2):120-38. doi: 10.1093/sleep/25.2.120. No abstract available.
PubMed 11902423Frauscher B, Iranzo A, Gaig C, Gschliesser V, Guaita M, Raffelseder V, Ehrmann L, Sola N, Salamero M, Tolosa E, Poewe W, Santamaria J, Hogl B; SINBAR (Sleep Innsbruck Barcelona) Group. Normative EMG values during REM sleep for the diagnosis of REM sleep behavior disorder. Sleep. 2012 Jun 1;35(6):835-47. doi: 10.5665/sleep.1886.
PubMed 22654203Anang JB, Gagnon JF, Bertrand JA, Romenets SR, Latreille V, Panisset M, Montplaisir J, Postuma RB. Predictors of dementia in Parkinson disease: a prospective cohort study. Neurology. 2014 Sep 30;83(14):1253-60. doi: 10.1212/WNL.0000000000000842. Epub 2014 Aug 29.
PubMed 25171928Anang JB, Nomura T, Romenets SR, Nakashima K, Gagnon JF, Postuma RB. Dementia Predictors in Parkinson Disease: A Validation Study. J Parkinsons Dis. 2017;7(1):159-162. doi: 10.3233/JPD-160925.
PubMed 27911340Sinforiani E, Pacchetti C, Zangaglia R, Pasotti C, Manni R, Nappi G. REM behavior disorder, hallucinations and cognitive impairment in Parkinson's disease: a two-year follow up. Mov Disord. 2008 Jul 30;23(10):1441-5. doi: 10.1002/mds.22126.
PubMed 18512749Postuma RB, Gagnon JF, Vendette M, Charland K, Montplaisir J. Manifestations of Parkinson disease differ in association with REM sleep behavior disorder. Mov Disord. 2008 Sep 15;23(12):1665-72. doi: 10.1002/mds.22099.
PubMed 18709686Postuma RB, Gagnon JF, Bertrand JA, Genier Marchand D, Montplaisir JY. Parkinson risk in idiopathic REM sleep behavior disorder: preparing for neuroprotective trials. Neurology. 2015 Mar 17;84(11):1104-13. doi: 10.1212/WNL.0000000000001364. Epub 2015 Feb 13.
PubMed 25681454Fereshtehnejad SM, Romenets SR, Anang JB, Latreille V, Gagnon JF, Postuma RB. New Clinical Subtypes of Parkinson Disease and Their Longitudinal Progression: A Prospective Cohort Comparison With Other Phenotypes. JAMA Neurol. 2015 Aug;72(8):863-73. doi: 10.1001/jamaneurol.2015.0703.
PubMed 26076039Postuma RB, Adler CH, Dugger BN, Hentz JG, Shill HA, Driver-Dunckley E, Sabbagh MN, Jacobson SA, Belden CM, Sue LI, Serrano G, Beach TG. REM sleep behavior disorder and neuropathology in Parkinson's disease. Mov Disord. 2015 Sep;30(10):1413-7. doi: 10.1002/mds.26347. Epub 2015 Aug 12.
PubMed 26265105Schenck CH, Boeve BF, Mahowald MW. Delayed emergence of a parkinsonian disorder or dementia in 81% of older men initially diagnosed with idiopathic rapid eye movement sleep behavior disorder: a 16-year update on a previously reported series. Sleep Med. 2013 Aug;14(8):744-8. doi: 10.1016/j.sleep.2012.10.009. Epub 2013 Jan 22.
PubMed 23347909Iranzo A, Fernandez-Arcos A, Tolosa E, Serradell M, Molinuevo JL, Valldeoriola F, Gelpi E, Vilaseca I, Sanchez-Valle R, Llado A, Gaig C, Santamaria J. Neurodegenerative disorder risk in idiopathic REM sleep behavior disorder: study in 174 patients. PLoS One. 2014 Feb 26;9(2):e89741. doi: 10.1371/journal.pone.0089741. eCollection 2014.
PubMed 24587002Postuma RB. Prodromal Parkinson's disease--using REM sleep behavior disorder as a window. Parkinsonism Relat Disord. 2014 Jan;20 Suppl 1:S1-4. doi: 10.1016/S1353-8020(13)00400-8.
PubMed 24262156Postuma RB, Iranzo A, Hogl B, Arnulf I, Ferini-Strambi L, Manni R, Miyamoto T, Oertel W, Dauvilliers Y, Ju YE, Puligheddu M, Sonka K, Pelletier A, Santamaria J, Frauscher B, Leu-Semenescu S, Zucconi M, Terzaghi M, Miyamoto M, Unger MM, Carlander B, Fantini ML, Montplaisir JY. Risk factors for neurodegeneration in idiopathic rapid eye movement sleep behavior disorder: a multicenter study. Ann Neurol. 2015 May;77(5):830-9. doi: 10.1002/ana.24385. Epub 2015 Mar 13.
PubMed 25767079
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Redictive Risk Factors of Conversion Into Idiopathic RBD. Italian Study [FAttori di Rischio PREdittivi di Conversione Nell'RBD Idiopatico. STudio ItalianO
- ClinicalTrials.gov ID
- NCT05262543
- Acronym / sponsor ID
- FARPRESTO / FarPresto01
- Conditions
- REM Sleep Behavior Disorder
- Keywords
- atonia, neurodegeneration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University of CagliariUniversity, hospital or other
- Collaborators
- University of Bologna, University of Genova, University of Pavia, Istituto Auxologico Italiano
- Study start
- 25 May 2020 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 2 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- Age: major of 18 years old
- iRBD diagnosis, according to diagnostic criteria of the ICSD second and third edition
Key exclusion criteria (1 listed)
- Impossibility to provide or withdraw informed consent and inability to read, write and understand the purpose and modality of the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Description of the socio-demographic and clinical characteristics of patients diagnosed with iRBD
Time frame: 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
Evaluation of the impact of iRBD on the quality of life and sleep
Time frame: 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
Identification of RBD phenotypes through different biomarkers
Time frame: May 25, 2020 - January 31, 2035
Validation of vPSG criteria for RBD diagnosis
Time frame: May 25, 2020 - January 31, 2035
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2024.
- Background: PubMed 16217051Fantini ML, Corona A, Clerici S, Ferini-Strambi L. Aggressive dream content without daytime aggressiveness in REM sleep behavior disorder. Neurology. 2005 Oct 11;65(7):1010-5. doi: 10.1212/01.wnl.0000179346.39655.e0.
- Background: PubMed 19204265Oudiette D, De Cock VC, Lavault S, Leu S, Vidailhet M, Arnulf I. Nonviolent elaborate behaviors may also occur in REM sleep behavior disorder. Neurology. 2009 Feb 10;72(6):551-7. doi: 10.1212/01.wnl.0000341936.78678.3a.
- Background: PubMed 11902423Schenck CH, Mahowald MW. REM sleep behavior disorder: clinical, developmental, and neuroscience perspectives 16 years after its formal identification in SLEEP. Sleep. 2002 Mar 15;25(2):120-38. doi: 10.1093/sleep/25.2.120. No abstract available.
- Background: PubMed 22654203Frauscher B, Iranzo A, Gaig C, Gschliesser V, Guaita M, Raffelseder V, Ehrmann L, Sola N, Salamero M, Tolosa E, Poewe W, Santamaria J, Hogl B; SINBAR (Sleep Innsbruck Barcelona) Group. Normative EMG values during REM sleep for the diagnosis of REM sleep behavior disorder. Sleep. 2012 Jun 1;35(6):835-47. doi: 10.5665/sleep.1886.
- Background: PubMed 25171928Anang JB, Gagnon JF, Bertrand JA, Romenets SR, Latreille V, Panisset M, Montplaisir J, Postuma RB. Predictors of dementia in Parkinson disease: a prospective cohort study. Neurology. 2014 Sep 30;83(14):1253-60. doi: 10.1212/WNL.0000000000000842. Epub 2014 Aug 29.
- Background: PubMed 27911340Anang JB, Nomura T, Romenets SR, Nakashima K, Gagnon JF, Postuma RB. Dementia Predictors in Parkinson Disease: A Validation Study. J Parkinsons Dis. 2017;7(1):159-162. doi: 10.3233/JPD-160925.
- Background: PubMed 18512749Sinforiani E, Pacchetti C, Zangaglia R, Pasotti C, Manni R, Nappi G. REM behavior disorder, hallucinations and cognitive impairment in Parkinson's disease: a two-year follow up. Mov Disord. 2008 Jul 30;23(10):1441-5. doi: 10.1002/mds.22126.
- Background: PubMed 18709686Postuma RB, Gagnon JF, Vendette M, Charland K, Montplaisir J. Manifestations of Parkinson disease differ in association with REM sleep behavior disorder. Mov Disord. 2008 Sep 15;23(12):1665-72. doi: 10.1002/mds.22099.
- Background: PubMed 25681454Postuma RB, Gagnon JF, Bertrand JA, Genier Marchand D, Montplaisir JY. Parkinson risk in idiopathic REM sleep behavior disorder: preparing for neuroprotective trials. Neurology. 2015 Mar 17;84(11):1104-13. doi: 10.1212/WNL.0000000000001364. Epub 2015 Feb 13.
- Background: PubMed 26076039Fereshtehnejad SM, Romenets SR, Anang JB, Latreille V, Gagnon JF, Postuma RB. New Clinical Subtypes of Parkinson Disease and Their Longitudinal Progression: A Prospective Cohort Comparison With Other Phenotypes. JAMA Neurol. 2015 Aug;72(8):863-73. doi: 10.1001/jamaneurol.2015.0703.
- Background: PubMed 26265105Postuma RB, Adler CH, Dugger BN, Hentz JG, Shill HA, Driver-Dunckley E, Sabbagh MN, Jacobson SA, Belden CM, Sue LI, Serrano G, Beach TG. REM sleep behavior disorder and neuropathology in Parkinson's disease. Mov Disord. 2015 Sep;30(10):1413-7. doi: 10.1002/mds.26347. Epub 2015 Aug 12.
- Background: PubMed 23347909Schenck CH, Boeve BF, Mahowald MW. Delayed emergence of a parkinsonian disorder or dementia in 81% of older men initially diagnosed with idiopathic rapid eye movement sleep behavior disorder: a 16-year update on a previously reported series. Sleep Med. 2013 Aug;14(8):744-8. doi: 10.1016/j.sleep.2012.10.009. Epub 2013 Jan 22.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Monica Puligheddu, MD,PhD principal investigator
University of Cagliari
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of REM Sleep Behavior Disorder, run by University of Cagliari at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Monica Puligheddu, MD, PhD (070 5109 6016, centrosonnoca@unica.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of predictive risk factors of phenoconversion in patients with iRBD (time frame: May 25, 2020 - January 31, 2035). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05262543, which also lists 20 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2024; AzTrials last refreshed its copy on 6 Nov 2026.