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

NCT02444637 | Completed Phase 4 DMC

• 1 other identifier: RACE_1.0
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Alzheimer Disease; CVA (Cerebrovascular Accident)

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Demonstrated Benefit in Global and Cognitive Measures

  2 Years

Secondary Outcomes (1)

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

  2 Years

Study Arms (1)

Rivastigmine (Exelon) Patch

EXPERIMENTAL

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

Rivastigmine DRUG

Also known as: Exelon

Rivastigmine (Exelon) Patch

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Neuroscience Institute: lead

Study Sites (1)

National Neuroscience Institute

Singapore, 308433, Singapore

Location

MeSH Terms

Conditions

Alzheimer Disease; Stroke

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior Consultant, Department of Neurology

Study Record Dates

• First Submitted: April 28, 2015
• First Posted: May 14, 2015
• Study Start: April 1, 2015
• Primary Completion: March 1, 2019
• Study Completion: March 1, 2019
• Last Updated: March 5, 2021

Record last verified: 2021-03

Locations

SG (1)