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

Alzheimer Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02444637
• Other study ID #: RACE_1.0
• Status: Completed
• Phase: Phase 4
• Start date: April 2015
• Est. completion date: March 2019

Study information

• Verified date: March 2021
• Source: National Neuroscience Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: March 2019
• Est. primary completion date: March 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• CVA (Cerebrovascular Accident)
• Stroke

Intervention

Drug:
• Rivastigmine

Locations

Country	Name	City	State
Singapore	National Neuroscience Institute	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
National Neuroscience Institute

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants with Demonstrated Benefit in Global and Cognitive Measures		2 Years
Secondary	Number of Participants with Adverse Events as a Measure of Safety and Tolerability		2 Years