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OpenTrials
Completed

NCT Number: NCT02444637

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

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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Key information

Conditions

Alzheimer Disease Brain Diseases CVA (Cerebrovascular Accident) Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Stroke Tauopathies Vascular Diseases

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

National Neuroscience Institute

Singapore, 308433

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rivastigmine

Drug

Other names: Exelon

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

Sponsors and collaborators

Lead sponsor

National Neuroscience Institute

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
May 14, 2015
Registry last updated
Mar 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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