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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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ClinicalTrials.gov Identifier: NCT02444637
Recruitment Status : Unknown
Verified May 2015 by Dr Nagaendran Kandiah, National Neuroscience Institute.
Recruitment status was:  Recruiting
First Posted : May 14, 2015
Last Update Posted : May 14, 2015
Sponsor:
Information provided by (Responsible Party):
Dr Nagaendran Kandiah, National Neuroscience Institute

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
Alzheimer Disease CVA (Cerebrovascular Accident) Drug: Rivastigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
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
Study Start Date : April 2015
Estimated Primary Completion Date : April 2017


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 Name: Exelon




Primary Outcome Measures :
  1. Number of Participants with Demonstrated Benefit in Global and Cognitive Measures [ Time Frame: 2 Years ]

Secondary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 2 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02444637


Contacts
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Contact: Jocelyn Cheong (65) 63577635 ctru@nni.com.sg

Locations
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Singapore
National Neuroscience Institute Recruiting
Singapore, Singapore, 308433
Contact: Jocelyn Cheong    (65) 63577635    ctru@nni.com.sg   
Principal Investigator: Nagaendran Kandiah, MRCP;FAMS         
Sponsors and Collaborators
National Neuroscience Institute

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Responsible Party: Dr Nagaendran Kandiah, Senior Consultant, Department of Neurology, National Neuroscience Institute
ClinicalTrials.gov Identifier: NCT02444637     History of Changes
Other Study ID Numbers: RACE_1.0
First Posted: May 14, 2015    Key Record Dates
Last Update Posted: May 14, 2015
Last Verified: May 2015
Additional relevant MeSH terms:
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Alzheimer Disease
Stroke
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Cerebrovascular Disorders
Vascular Diseases
Cardiovascular Diseases
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents