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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 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
Lead sponsor
Asset
Rivastigmine
Listed sites
9
Recruiting sites
-
Enrollment
100
actual
Study population
Alzheimer’s disease
Key I/E criterion
•Alzheimer's disease
Primary endpoint
•Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Drug assets
Study populations
Who this study enrolls
Eligibility
Who can enroll
Inclusion criteria
1. Patients willing to participate in the study by providing written informed consent.
2. 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
Exclusion criteria
1. Contraindication as per PI
2. Patients simultaneously participating in other studies
3. 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.
4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
Endpoints (14)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Global cognition
2 endpointsChange From Baseline in Mini-Mental State Examination (MMSE)
Time frame:Baseline, 16 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Change From Baseline in Mini-Mental State Examination (MMSE)
Time frame:Baseline, 16 weeks
Mini-Mental State Examination (MMSE)
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchn=63 Participants | 3.1 | 4.79 |
Function / daily living
2 endpointsChange 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
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
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
ADCS-Activities of Daily Living (ADCS-ADL)
change from baseline, improvement
Posted result
| Group | Value (mean), Score on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchn=69 Participants | -1.6 | 10.47 |
Caregiver / quality of life
4 endpointsCompliance by Caregiver Medication Questionnaire (CMQ) Score
Time frame:Week 16
descriptive
Patch Adhesion to the Skin
Time frame:Week 16
descriptive
Compliance by Caregiver Medication Questionnaire (CMQ) Score
Time frame:Week 16
descriptive
Posted result
| Group | Value (mean), Score on a scale | Standard deviation |
|---|---|---|
| Rivastigmine Patchn=69 Participants | 8.1 | 2.78 |
Patch Adhesion to the Skin
Time frame:Week 16
descriptive
Posted result
| Group | Value (number), participants | Reported bounds |
|---|---|---|
| Rivastigmine PatchScore 0n=70 Participants | 60 | - |
| Score 1n=70 Participants | 4 | - |
| Score 2n=70 Participants | 0 | - |
| Score 3n=70 Participants | 4 | - |
| Score 4n=70 Participants | 2 | - |
Safety / tolerability / PK
2 endpointsNumber 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.
event count, event
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.
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Rivastigmine PatchAt least one AEn=100 Participants | 32 | - |
| AEs related to study treatmentn=100 Participants | 13 | - |
| AEs leading to treatment discontinuationn=100 Participants | 4 | - |
| At least one SAEn=100 Participants | 4 | - |
Other (unclassified)
4 endpointsNumber of Participants With a Skin Irritation
Time frame:Week 16
event count, event
Number of Participants With a Urinary Tract Infection (UTI)
Time frame:16 weeks
event count, event
Number of Participants With a Skin Irritation
Time frame:Week 16
event count, event
Posted result
| Group | Value (number), participants | Reported bounds |
|---|---|---|
| Rivastigmine PatchScore 0n=70 Participants | 65 | - |
| Score 1n=70 Participants | 3 | - |
| Score 2n=70 Participants | 2 | - |
| Score 3 to 5n=70 Participants | 0 | - |
Number of Participants With a Urinary Tract Infection (UTI)
Time frame:16 weeks
event count, event
Posted result
| Group | Value (count_of_participants), Participants | Reported bounds |
|---|---|---|
| Rivastigmine Patchn=100 Participants | 10 | - |
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 21, 2026 snapshot.