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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 March 2021
• Main ID: NCT02444637
• Date of registration: 28/04/2015
• Prospective Registration: No
• Primary sponsor: National Neuroscience Institute
• Public title: Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
• Scientific title: Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
• Date of first enrolment: April 2015
• Target sample size: 100
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02444637
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Singapore

Key inclusion & exclusion 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



Age minimum: 50 Years
Age maximum: 85 Years
Gender: All

Health Condition(s) or Problem(s) studied

CVA (Cerebrovascular Accident)

Alzheimer Disease

Intervention(s)

Drug: Rivastigmine

Primary Outcome(s)

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

Secondary Outcome(s)

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

Secondary ID(s)

RACE_1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors