Clinical trial NCT02989402: A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer, Rivastigmine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-12-12
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: 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:
measure: Change From Baseline in Mini-Mental State Examination (MMSE)
timeFrame: Baseline, 16 weeks
measure: Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score
timeFrame: Baseline, 16 weeks
measure: Compliance by Caregiver Medication Questionnaire (CMQ) Score
timeFrame: Week 16
measure: Number of Participants With a Skin Irritation
timeFrame: Week 16
measure: Number of Participants With a Urinary Tract Infection (UTI)
timeFrame: 16 weeks
measure: Patch Adhesion to the Skin
timeFrame: Week 16
Other outcomes:
Locations:
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Banglaore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bengaluru
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mumbai
country: India
facility: Novartis Investigative Site
state: Maharashtra
city: Hyderabad
country: India
facility: Novartis Investigative Site
state: Telangana
city: Lucknow
country: India
facility: Novartis Investigative Site
state: Uttar Pradesh
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
city: Kolkata
country: India
facility: Novartis Investigative Site
state: West Bengal
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: