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NCT03353207
Striatal Dopamine Transmission in Individuals With Isolated Rapid Eye Movement Sleep With Atonia: a Search for Precursor Biomarker for Neurodegeneration
trial in REM Sleep Behavior Disorder in 50 participants. Completed in 8 February 2021.
1 July 2019
Quick facts
| Lead sponsor | Chinese University of Hong Kong |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 50 |
| Start date | 30 October 2017 |
| Primary completion | 1 July 2019 |
| Estimated completion | 8 February 2021 |
| Sites | 1 location across Hong Kong |
Conditions studied
- REM Sleep Behavior Disorder — all drugs for REM Sleep Behavior Disorder →
- Neurodegenerative Diseases — all drugs for Neurodegenerative Diseases →
Sponsor
Chinese University of Hong Kong
Who can join
Adults 45 to 65, any sex, with REM Sleep Behavior Disorder or Neurodegenerative Diseases. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Previous studies have confirmed that most patients with idiopathic REM sleep behaviour disorder (iRBD) eventually develop neurodegenerative diseases. In addition, REM sleep without atonia (RSWA), a hallmark of RBD feature, is a significant predictor of development of neurodegenerative diseases in patients with iRBD. Some preliminary studies have implied that isolated RSWA in the absence of RBD symptoms may also indicate neurodegeneration. However, this speculation needs to be confirmed by more refined study with sophisticated measures in both RSWA and markers of neurodegeneration Objectives: 1) to determine the differences in striatal dopamine transmission and other markers of neurodegeneration among individuals with isolated RSWA and healthy controls; 2) to examine the correlation of severity of RSWA with striatal dopamine transmission. Design: Case-control study Setting: Community-based sample Participants: 1) iRBD first degree relatives with isolated RSWA (n=18) 2) iRBD first degree relatives without isolated RSWA (n=18) 3) Community-based health controls without isolated RSWA (n=18) Main outcome measures: 1. The dopamine transmission as measured by triple-tracer PET/ CT imaging protocol including 18F-DOPA, 11C-Raclopride and 18F-FDG images; 2. Brain glucose metabolism and neurocognitive measures; 3. Severity of EMG activity during REM sleep
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03353207
- Europe PMC full search
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Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03353207 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Chinese University of Hong Kong
- Last refreshed: 24 February 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03353207.
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