Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05353881 |
| Other study ID # |
RGC14107520 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
January 3, 2022 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
April 2024 |
| Source |
Chinese University of Hong Kong |
| Contact |
Mandy Yu, MPH |
| Phone |
852-39197593 |
| Email |
mandyyu[@]cuhk.edu.hk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
REM sleep behavior disorder is a novel and distinct parasomnia characterized by recurrent
dream enactment behaviors (DEBs) and REM sleep without atonia (RSWA) during polysomnographic
assessment, with a male predominance and typical onset age at early 60's. The majority of
patients with idiopathic RBD (iRBD) will eventually develop α-synucleinopathy, for instance
Parkinson's disease (PD). Thus, iRBD has been considered as a highly specific precursor of
α-synucleinopathy-related neurodegeneration. Recently, increasing studies have found that
some participants present with only RSWA or DEBs (but without sufficient RSWA), which does
not meet the diagnostic criteria for RBD. It has been suggested that these participants with
subclinical features (either DEBs or RSWA) might represent a condition known as prodromal
RBD. Several emerging evidence, including our own study, have implied a link between isolated
RSWA (RSWA without DEBs) and markers of α-synucleinopathy-related neurodegeneration. However,
it is still unclear whether the other condition related to RBD, i.e. recurrent DEBs but
without sufficient RSWA, is related to a certain degree of α-synucleinopathy. In this regard,
the novel concept of recurrent DEBs but without sufficient RSWA, also termed as
prodromal/isolated RBD by some researchers, requires validation by further evidence in terms
of clinical feature and neurodegenerative prodromal markers perspectives.
Description:
This proposed study is a case-control study, which aims to determine whether recurrent DEBs
but without sufficient RSWA represents an early stage of α-synucleinopathy. The investigators
will recruit 62 participants with recurrent DEBs but without sufficient RSWA and their age-,
sex- matched controls from the community and on-going projects. All participants will undergo
clinical interview, comprehensive measures of prodromal markers of neurodegeneration
(including excessive daytime sleepiness, olfactory functioning, constipation, erectile
dysfunction, urinary dysfunction, symptomatic hypotension, depression, and clinical motor
markers) as suggested by the International Parkinson and Movement Disorder Society (MDS)
research criteria. In addition, a subset of the sample (n = 26 in each group) will undergo
the triple-tracer positron emission tomography/computed tomography (PET/CT) imaging protocol
of 18F-DOPA, to determine dopamine functions in putamen. This proposed study will help to
disentangle the core features of RBD and validate the concept of prodromal RBD with reference
to prodromal markers related to α-synucleinopathy neurodegeneration.
