Extensive phenotyping of REM sleep behavior disorder in patients with Parkinson*s disease and Dementia with Lewy bodies

Extensive phenotyping of REM sleep behavior disorder in patients with Parkinson's disease and Dementia with Lewy bodies - REMIND (REM-sleep In Neurological Disorders)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54258

Enrollment

Registered

2020-07-07

Start date

2022-01-31

Completion date

Unknown

Last updated

2026-02-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

REM sleep behavior disorder

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Diagnosed with probable or possible DLB according to the McKeith diagnostic criteria OR diagnosed with PD according to the Movement Disorder Society clinical diagnostic criteria for Parkinson's disease OR diagnosed with isolated REM-sleep behavior disorder (RBD) according to the ICSD-3 criteriaBeing able to read and understand Dutch Being able to understand the aim of the study and the study procedure and give written informed consent For PD and DLB: absence of medication that is known to precipitate RSWA/RBD, particularly the  antidepressants venlafaxine, serotonin-specific reuptake inhibitors (SSRIs), mirtazapine and other antidepressant agents (but not bupropion), and medication that is known to reduce RSWA (melatonin). For the iRBD cases these medications are not exclusion criteria.For PD and DLB: signed statement of eligibility to participate from the treating specialist (e.g. neurologist)For DLB: presence of a caregiver for at least 5 days a week, who will join the patient at all visits.For isolated RBD: already having been informed about the risk of conversion to PD/DLB

Exclusion criteria

Exclusion criteria: A history of neurodegenerative disorders that affect the central nervous system other than PD or DLBA contraindication to MRI (i.e. metal implants, cardiac pacemakers, prior exposition to metal flakes without an X-ray showing absence of embedded metal in the body, claustrophobia or feeling uncomfortable in small, enclosed spaces, being pregnant)Patients who have received brain surgery for Parkinson’s diseaseUnwillingness to be informed of unexpected medical findingsAfter polysomnographyuntreated moderate to severe obstructive sleep apnea (AHI=15/h) none or insufficient amounts (<5 min) of REM sleep during polysomnography

Design outcomes

Primary

Measure	Time frame
Group comparisons (Parkinson's disease/DLB with RBD versus without RBD and isolated RBD) and correlation analysis with RSWA for the entire sample will be performed for:Clinical characteristics (i.e. motor, psychiatric, autonomic and sleep symptoms)Brain activity during rest, using fMRIBrain anatomy in terms of cortical thickness, regional volume and white matter integrity, using structural MRI and DTIIron levels in the substantia nigra and basal ganglia, using quantitative MRIBlood values (and if available from other studies also CSF values)For isolated RBD: values from stool sample and skin biopsy (alpha-synuclein protein)	—

Measure

Time frame

Group comparisons (Parkinson's disease/DLB with RBD versus without RBD and isolated RBD) and correlation analysis with RSWA for the entire sample will be performed for:Clinical characteristics (i.e. motor, psychiatric, autonomic and sleep symptoms)Brain activity during rest, using fMRIBrain anatomy in terms of cortical thickness, regional volume and white matter integrity, using structural MRI and DTIIron levels in the substantia nigra and basal ganglia, using quantitative MRIBlood values (and if available from other studies also CSF values)For isolated RBD: values from stool sample and skin biopsy (alpha-synuclein protein)

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Countries

Netherlands

Contacts

Public ContactY.D. Werf

Amsterdam UMC

yd.vanderwerf@amsterdamumc.nl020-4445912

Outcome results