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

NCT ID: NCT02444637

Last Updated: 2021-03-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-04-30
• Study Completion Date: 2019-03-31

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Rivastigmine

Intervention Type: DRUG

Interventions

Rivastigmine

Intervention Type: DRUG

Other Intervention Names

Exelon

Eligibility 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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Neuroscience Institute

OTHER

Sponsor Role: lead

Responsible Party

Dr Nagaendran Kandiah

Senior Consultant, Department of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

National Neuroscience Institute

Singapore, , Singapore

Countries

Singapore

Other Identifiers

RACE_1.0

Identifier Type: -

Identifier Source: org_study_id