Alzheimer's DiseasePhase 4NCT02989402
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
A Phase 4 study testing Rivastigmine in people with Alzheimer's Disease, run by Novartis Pharmaceuticals at 9 sites in India.
Trial summary
This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- Rivastigmine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 9 sitesIndia
- Study dates
- 31 Dec 2018to 8 Dec 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients willing to participate in the study by providing written informed consent.
- Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3 .Patient's prescribed with rivastigmine 27mg -15 cm^2 transdermal patch as per discretion of treating physician
Who cannot join
- Contraindication as per PI
- Patients simultaneously participating in other studies
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)], whichever is longer.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
India9 sites
Novartis Investigative Site
Bangalore, Karnataka, 560 055
Novartis Investigative Site
Bangalore, Karnataka, 560052
Novartis Investigative Site
Banglaore, Karnataka, 560052
Novartis Investigative Site
Bengaluru, Karnataka, 560005
Novartis Investigative Site
Hyderabad, Telangana, 500082
Novartis Investigative Site
Kolkata, West Bengal, 700017
Novartis Investigative Site
Kolkata, West Bengal, 700054
Novartis Investigative Site
Lucknow, Uttar Pradesh, 226003
Novartis Investigative Site
Mumbai, Maharashtra, 400 053
About this study
Official title: A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch
This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.
Read the detailed description
This was a multicenter, prospective, single-arm, open-label, phase IV study to evaluate safety, tolerability and effectiveness of Rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. The prescription decision was independent of the decision for inclusion in the study.
- Conditions
- Alzheimer's Disease
- Being tested
- Rivastigmine
- Keywords
- Alzheimer, Rivastigmine
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RivastigmineDrug
15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day
| Study group | Role | What they receive |
|---|---|---|
| Rivastigmine patch | Experimental | 15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day Receives: Drug: Rivastigmine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs.
Measured: Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.
Secondary outcomes (6)
Change From Baseline in Mini-Mental State Examination (MMSE)
The MMSE is a brief, practical screening test for cognitive dysfunction. The test consists of five sections (orientation, registration, attention-calculation, recall, and language); and results in a total score can range from 0 to 30, with higher scores indicating better function.
Measured: Baseline, 16 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score
Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score is a tool to assess the ability of patients with moderate to severe dementia to perform activities of daily living. The ADCS-ADL SIV assessment is done at start and end of visit. The assessment includes 19 questions. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.
Measured: Baseline, 16 weeks
Compliance by Caregiver Medication Questionnaire (CMQ) Score
Caregiver evaluation of the medications used for Alzheimer Disease was assessed using the Caregiver Medication Questionnaire (CMQ). Compliance was rated on a scale from 0 = "never took the medication as prescribed" to 10 = "always took the medication as prescribed."
Measured: Week 16
Number of Participants With a Skin Irritation
The following score system were used to assess skin irritation:
- Dermal response:
Score 0 = No erythema (normal skin) Score 1 = Erythema barely visible Score 2 = Mild erythema Score 3 = Moderate erythema Score 4 = Severe erythema Score 5 = Severe erythema with vesicles or blisters
Measured: Week 16
Number of Participants With a Urinary Tract Infection (UTI)
Urine samples were collected to assess the number of patients with UTI.
Measured: 16 weeks
Patch Adhesion to the Skin
Patch adhesion to the skin was evaluated by the caregiver. An estimate of the patch adherence was provided and graded according to the patch adhesiveness score.
Following scores were used to capture comments relating to patch adhesion:
0 = 90 % adhered (essentially no lift off of the skin)
- = 75% to < 90% adhered (some edges only lifting off of the skin)
- = 50% to < 75% adhered (less than half of the patch lifting off the skin)
- = < 50% adhered but not detached (more than half the system lifting off of the skin without falling off)
- = the patch was completely detached. The score ranges from 1 to 4 where a higher score indicates less adhesion.
Measured: Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2016 (estimated)
- Study start31 Dec 2018
- Primary completion7 Dec 2022
- Study completion8 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
- 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
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02989402
- Sponsor's protocol ID
- CENA713DIN01
- Status last verified
- Dec 2023
- First submitted
- 8 Dec 2016
- Last updated
- 31 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, 16 Week, Phase IV Study to Evaluate Safety, Tolerability and Effectiveness in Patients With Severe Dementia of the Alzheimer's Type Exposed to Rivastigmine (Exelon)15cm2 Transdermal Patch
- ClinicalTrials.gov ID
- NCT02989402
- Acronym / sponsor ID
- CENA713DIN01
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer, Rivastigmine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 31 Dec 2018 (actual)
- Primary completion
- 7 Dec 2022 (actual)
- Study completion
- 8 Dec 2022 (actual)
- First posted
- 12 Dec 2016 (estimated)
- Results
- Posted 31 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.
Detailed description
This was a multicenter, prospective, single-arm, open-label, phase IV study to evaluate safety, tolerability and effectiveness of Rivastigmine 27 mg -15 cm^2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician. Male and female patients who were treated according to local routine clinical practice were enrolled in the study upon signing informed consent. The prescription decision was independent of the decision for inclusion in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rivastigmine patch | Experimental | Drug: Rivastigmine15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Patients willing to participate in the study by providing written informed consent.
- Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3 .Patient's prescribed with rivastigmine 27mg -15 cm^2 transdermal patch as per discretion of treating physician
Key exclusion criteria (4 listed)
- Contraindication as per PI
- Patients simultaneously participating in other studies
- Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days (for small molecules) /until the expected PD effect has returned to baseline (for biologics)], whichever is longer.
- History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
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 |
|---|---|---|
| Rivastigmine15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day | Drug | Rivastigmine patch |
Primary outcome
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.
Number of participants with treatment emergent AEs (any AE regardless of seriousness), AEs related to study treatment, AEs led to study treatment discontinuation, and SAEs.
6 secondary outcomes
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame: Baseline, 16 weeks
Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score
Time frame: Baseline, 16 weeks
Compliance by Caregiver Medication Questionnaire (CMQ) Score
Time frame: Week 16
Number of Participants With a Skin Irritation
Time frame: Week 16
Number of Participants With a Urinary Tract Infection (UTI)
Time frame: 16 weeks
Patch Adhesion to the Skin
Time frame: Week 16
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
9 sites 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's Disease, run by Novartis Pharmaceuticals at 9 sites in India.
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 2 inclusion and 4 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 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in India. 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?
Yes. Results are posted in the registry (first posted 31 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Adverse events were reported from first dose of study treatment until end of study treatment, plus 30 days post treatment, up to a maximum duration of approximately 142 days.). 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 31 May 2024.