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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02444637
Enrollment
100
Registered
2015-05-14
Start date
2015-04-30
Completion date
2019-03-31
Last updated
2021-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease, CVA (Cerebrovascular Accident)

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.

Interventions

DRUGRivastigmine

Sponsors

National Neuroscience Institute
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures2 Years

Secondary

MeasureTime frame
Number of Participants with Adverse Events as a Measure of Safety and Tolerability2 Years

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026