Phase 4
N=100
A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
Alzheimer's Disease
Bottom Line
View on ClinicalTrials.gov: NCT02989402 ↗Enrolled (actual)
100
Serious AEs
4.0%
Results posted
May 2024
Primary outcome: Primary: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) — 32; 13; 4; 4 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Rivastigmine (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Dec 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) |
32; 13; 4; 4 | — |
| SECONDARY Change From Baseline in Mini-Mental State Examination (MMSE) |
3.1 | — |
| SECONDARY Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score |
-1.6 | — |
| SECONDARY Compliance by Caregiver Medication Questionnaire (CMQ) Score |
8.1 | — |
| SECONDARY Number of Participants With a Skin Irritation |
65; 3; 2; 0 | — |
| SECONDARY Number of Participants With a Urinary Tract Infection (UTI) |
10 | — |
| SECONDARY Patch Adhesion to the Skin |
60; 4; 0; 4; 2 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02989402). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.