Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
Primary Purpose
Alzheimer Disease, CVA (Cerebrovascular Accident)
Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Rivastigmine
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer Disease
Eligibility Criteria
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
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
Sites / Locations
- National Neuroscience Institute
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Rivastigmine (Exelon) Patch
Arm Description
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.
Outcomes
Primary Outcome Measures
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
Secondary Outcome Measures
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Full Information
NCT ID
NCT02444637
First Posted
April 28, 2015
Last Updated
March 3, 2021
Sponsor
National Neuroscience Institute
1. Study Identification
Unique Protocol Identification Number
NCT02444637
Brief Title
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
Official Title
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 2015 (Actual)
Primary Completion Date
March 2019 (Actual)
Study Completion Date
March 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Neuroscience Institute
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, CVA (Cerebrovascular Accident)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Rivastigmine (Exelon) Patch
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Rivastigmine
Other Intervention Name(s)
Exelon
Primary Outcome Measure Information:
Title
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
Time Frame
2 Years
Secondary Outcome Measure Information:
Title
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
2 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Facility Information:
Facility Name
National Neuroscience Institute
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
12. IPD Sharing Statement
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Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
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