Alzheimer DiseasePhase 4NCT02444637
Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage AD Having Coexisting svCVD
A Phase 4 study testing Rivastigmine in people with Alzheimer Disease and CVA (Cerebrovascular Accident), run by National Neuroscience Institute at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Alzheimer Disease, CVA (Cerebrovascular Accident)
- What is being tested?
- Rivastigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- Apr 2015to Mar 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
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)
- Being tested
- Rivastigmine
- Medical subject headings
- Alzheimer Disease, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
Also called Exelon
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Rivastigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
Measured: 2 Years
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startApr 2015
- Primary completionMar 2019
- Study completionMar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Neuroscience Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Nagaendran Kandiah, National Neuroscience Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444637
- Sponsor's protocol ID
- RACE_1.0
- Status last verified
- Mar 2021
- First submitted
- 28 Apr 2015
- Last updated
- 5 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Trial of Rivastigmine Patch in Subjects With Mild to Moderate Stage Alzheimer's Disease Having Coexisting Small Vessel Cerebrovascular Disease
- ClinicalTrials.gov ID
- NCT02444637
- Acronym / sponsor ID
- RACE_1.0
- Conditions
- Alzheimer Disease, CVA (Cerebrovascular Accident)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- National Neuroscience InstituteUniversity, hospital or other
- Study start
- Apr 2015 (actual)
- Primary completion
- Mar 2019 (actual)
- Study completion
- Mar 2019 (actual)
- First posted
- 14 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine (Exelon) Patch | Experimental | Drug: RivastigmineFor 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RivastigmineAlso: Exelon | Drug | Rivastigmine (Exelon) Patch |
Primary outcome
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures
Time frame: 2 Years
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Rivastigmine in people with Alzheimer Disease and CVA (Cerebrovascular Accident), run by National Neuroscience Institute at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with Demonstrated Benefit in Global and Cognitive Measures (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2021.