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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
National Neuroscience Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
April 28, 2015
Last Updated
March 3, 2021
Sponsor
National Neuroscience Institute
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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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