Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD

Phase 4

Completed

• Conditions: Alzheimer Disease; CVA (Cerebrovascular Accident)
• Interventions: Drug: Rivastigmine

• Registration Number: NCT02444637
• Lead Sponsor: National Neuroscience Institute

Brief Summary

Rivastigmine, an acetylcholinesterase inhibitor which has been approved by FDA \& HSA, is authorized for use in the treatment of mild to moderate dementia of the Alzheimer's type.

In this trial, the investigators will be studying the effectiveness of Rivastigmine in subjects with AD and cerebrovascular disease.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-04-28
• Study First Submitted QC: 2015-05-11
• Study First Posted: 2015-05-14
• Primary Completion: 2019-03
• Study Completion: 2019-03
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-03
• Last Update Posted: 2021-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age between 50-85 years
• Diagnosis of dementia of the Alzheimer's type according to the National Institute of Ageing-Alzheimer's Association Criteriah
• MRI brain (with T2 or FLAIR sequences) performed within a 12 month period from time of recruitment demonstrating the presence of WMH of ≥2 on the Fazekas scale (Score range of 0-3 wherein a score of 1 indicates mild WMH, 2 indicates moderate WMH and 3 indicates severe WMH).i
• Clinical Dementia Rating score of 1-2j
• Mini-Mental State Examination (MMSE) scores of 12-26 inclusivek
• English or Mandarin speaking, literate participants

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Exclusion Criteria

• Severe neurological, psychiatric or systemic disease which in the opinion of the clinician could interfere with trial assessments
• The use of any investigational drugs, new psychotropic or dopaminergic agents, cholinesterase inhibitors or anti-cholinergic agents during the 4 weeks prior to recruitment
• Known skin allergy or previous allergic reaction to Rivastigmine patch

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Rivastigmine (Exelon) Patch	Rivastigmine	For the first 4 weeks of the study, subjects will receive Rivastigmine patch 4.6mg/24 hours. Thereafter, subjects will receive Rivastigmine patch 9.5mg/24 hours.

Primary Outcome Measures

Name	Time	Method
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures	2 Years

Secondary Outcome Measures

Name	Time	Method
Number of Participants with Adverse Events as a Measure of Safety and Tolerability	2 Years

Trial Locations

Locations (1)

National Neuroscience Institute; 🇸🇬 Singapore, Singapore