Efficacy of rivastigmine transdermal patch in patients with mild cognitive impairment with Lewy bodies

Phase 4

• Conditions: REM sleep behavior disorder and presence of probable LB-MCI; Nervous System Diseases

• Registration Number: ISRCTN17719546
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2024-03-14
• Last Update Posted: 25 March 2024
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 10

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified