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

Sponsor
National Neuroscience Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02444637
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
47
Actual Duration (Months)
2.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
Actual Study Start Date :
Apr 1, 2015
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
Mar 1, 2019

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Number of Participants with Demonstrated Benefit in Global and Cognitive Measures [2 Years]

    Secondary Outcome Measures

    1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [2 Years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Neuroscience Institute Singapore Singapore 308433

    Sponsors and Collaborators

    • National Neuroscience Institute

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr Nagaendran Kandiah, Senior Consultant, Department of Neurology, National Neuroscience Institute
    ClinicalTrials.gov Identifier:
    NCT02444637
    Other Study ID Numbers:
    • RACE_1.0
    First Posted:
    May 14, 2015
    Last Update Posted:
    Mar 5, 2021
    Last Verified:
    Mar 1, 2021
    Additional relevant MeSH terms:
    Alzheimer Disease
    Stroke
    Rivastigmine

    Study Results

    No Results Posted as of Mar 5, 2021