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CompletedNCT02444637Updated Mar 5, 2021

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

A Phase 4 interventional study of Rivastigmine in Alzheimer Disease and CVA (Cerebrovascular Accident), sponsored by National Neuroscience Institute. Completed at 1 site in Singapore. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2021-03-05.

Sponsored by National Neuroscience Institute · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
100
Allocation
Not applicable
Ages
50 Years to 85 Years
Sex
All
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Study 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.

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Conditions studied

  • Alzheimer Disease
  • CVA (Cerebrovascular Accident)
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In context

Alzheimer Disease

3,678 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 100 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

National Neuroscience Institute is the lead sponsor of 10 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
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

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

Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
100 participants (actual)

Study arms

  • 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

Interventions

  • DrugRivastigmine

    Also known as: Exelon

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What researchers measure

Primary outcomes

  1. Number of Participants with Demonstrated Benefit in Global and Cognitive Measures

    Time frame: 2 Years

Secondary outcomes

  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability

    Time frame: 2 Years

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Study locations

1 site
  • National Neuroscience Institute
    Singapore, 308433, Singapore
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 5, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02444637
Lead sponsor
National Neuroscience Institute
Responsible party
Dr Nagaendran Kandiah (Senior Consultant, Department of Neurology, National Neuroscience Institute) — Principal investigator
First posted
May 14, 2015
Start date
Apr 2015
Primary completion
Mar 2019
Completion
Mar 2019
Last update
Mar 5, 2021

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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