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

March 3, 2021 updated by: Dr Nagaendran Kandiah, National Neuroscience Institute

Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
        • National Neuroscience Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Rivastigmine (Exelon) Patch
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.
Drug: Rivastigmine
Other Names:
  • Exelon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
Time Frame: 2 Years
2 Years

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame: 2 Years
2 Years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Neuroscience Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 1, 2015

Primary Completion (ACTUAL)

March 1, 2019

Study Completion (ACTUAL)

March 1, 2019

Study Registration Dates

First Submitted

April 28, 2015

First Submitted That Met QC Criteria

May 11, 2015

First Posted (ESTIMATE)

May 14, 2015

Study Record Updates

Last Update Posted (ACTUAL)

March 5, 2021

Last Update Submitted That Met QC Criteria

March 3, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RACE_1.0

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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