A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
100 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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