REM sleep behavior disorder and presence of probable LB-MCI Nervous System Diseases
Conditions
Interventions
Rivastigmine transdermal patch will be started at a standard starting dose of 4.6 mg/24 hours. If the subject tolerates the treatment, the dosage will be increased to 9.5 mg/24 hours after 4 weeks, an
Sponsors
Chinese University of Hong Kong
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Aged 60 to 80 years old 2. Video-polysomnography confirmed diagnosis of RBD 3. Presence of probable LB-MCI as diagnosed by a specialist psychiatrist or neurologist according to the Research criteria for the diagnosis of prodromal dementia with Lewy bodies by the prodromal DLB Diagnostic Study Group 4. Capable of giving written informed consent
Exclusion criteria
Exclusion criteria: 1. Presence of Parkinson’s disease, multi-system atrophy, or other neurodegenerative disorders 2. Condition that is contraindicated against rivastigmine patch: Presence of heart block, history of allergic reaction to rivastigmine, or drugs that have cross-hypersensitivity with rivastigmine 3. Conditions that render adverse events more likely: sick sinus syndrome, conduction defects (sino-atrial block, atrioventricular block), gastroduodenal ulcerative conditions (including those predisposed to such situations by concomitant medications), asthma or chronic obstructive pulmonary disease, urinary obstruction, and seizures 4. Body weight <50 kg 5. history of being treated with AChEI or other cognitive enhancers 6. Undergoing other structural, non-pharmacological cognitive-enhancing therapy 7. Other suspected causes of primary causes of cognitive impairment as suggested by clinical examination, blood tests and imaging investigations
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Global cognitive function measured using the Hong Kong Montreal Cognitive Assessment (MoCA-HK) score between T1 (6 months post-treatment) and T0 (baseline assessment). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Global cognitive function measured using the Hong Kong Montreal Cognitive Assessment (MoCA-HK) between T0.5 (3 months post-treatment) and T0 (baseline assessment) 2. Depressive symptoms measured using the Patient Health Questionnaire-9 (PHQ-9) score between T1 and T0 3. Anxiety symptoms measured using the General Anxiety Disorder-7 (GAD-7) score between T1 and T0 4. Quality of life measured using the WHOQOL-BREF score (excluding the Environment domain) between T1 and T0 | — |
Countries
Hong Kong
Contacts
Public ContactSteven, Wai Ho Chau
Outcome results
None listed