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 Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02989402
• Other study ID #: CENA713DIN01
• Status: Completed
• Phase: Phase 4
• Start date: December 31, 2018
• Est. completion date: December 8, 2022

Study information

• Verified date: December 2023
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 8, 2022
• Est. primary completion date: December 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Drug:
• Rivastigmine
15 cm^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day

Locations

Country	Name	City	State
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Bangalore	Karnataka
India	Novartis Investigative Site	Banglaore	Karnataka
India	Novartis Investigative Site	Bengaluru	Karnataka
India	Novartis Investigative Site	Hyderabad	Telangana
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Kolkata	West Bengal
India	Novartis Investigative Site	Lucknow	Uttar Pradesh
India	Novartis Investigative Site	Mumbai	Maharashtra

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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	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.	Baseline, 16 weeks
Secondary	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.	Baseline, 16 weeks
Secondary	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."	Week 16
Secondary	Number of Participants With a Skin Irritation	The following score system were used to assess skin irritation: I. 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	Week 16
Secondary	Number of Participants With a Urinary Tract Infection (UTI)	Urine samples were collected to assess the number of patients with UTI.	16 weeks
Secondary	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.	Week 16