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

This is a multicenter, prospective, phase IV study evaluating safety, tolerability and effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with severe dementia of the Alzheimer's type as per discretion of treating physician.

Study Overview

• Status: Completed
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Rivastigmine

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Phase 4

Contacts and Locations

Study Locations

• India
  • Karnataka
    • Bangalore, Karnataka, India, 560 055
      • Novartis Investigative Site
    • Bangalore, Karnataka, India, 560052
      • Novartis Investigative Site
    • Banglaore, Karnataka, India, 560052
      • Novartis Investigative Site
    • Bengaluru, Karnataka, India, 560005
      • Novartis Investigative Site
  • Maharashtra
    • Mumbai, Maharashtra, India, 400 053
      • Novartis Investigative Site
  • Telangana
    • Hyderabad, Telangana, India, 500082
      • Novartis Investigative Site
  • Uttar Pradesh
    • Lucknow, Uttar Pradesh, India, 226003
      • Novartis Investigative Site
  • West Bengal
    • Kolkata, West Bengal, India, 700017
      • Novartis Investigative Site
    • Kolkata, West Bengal, India, 700 107
      • Novartis Investigative Site
    • Kolkata, West Bengal, India, 700054
      • Novartis Investigative Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 cm2 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Rivastigmine patch; 15 cm2 patch sizes loaded with 27 mg of rivastigmine	Drug: Rivastigmine; 15 cm2 patch sizes loaded with 27 mg of rivastigmine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Number of participants with Adverse events as a measure of Safety and tolerability	16 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in Mini-Mental State Examination (MMSE	The test consists of five sections (orientation, registration, attention-calculation, recall, and language) and results in a total possible score of 30, with higher scores indicating better function. MMSE shall be recorded at the start and end of study provided it is a part of routine clinical practic	baseline, 16 weeks
Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score	This 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 score for each questions ranges as follows: questions 1 - 5, 0 - 15; questions 6 - 8, 0 - 13, questions 9 - 12, 0 - 12; questions 13 - 15, 0 - 10 and questions 16 - 19, 0 - 4. The total score ranges from 0 - 54. Higher scores indicate less functional impairment and greater competence.	baseline, 16 weeks
Mean Caregiver Medication Questionnaire (CMQ) score	The total compliance is rated on an 10 point scale: 0 = "never took the medication as prescribed"; maximum of 10 = "always took the medication as prescribed."	baseline, 16 weeks
Number of participants with a skin irritation	The following score system will be used to assess skin irritation: I. Dermal response: 0 = No erythema (normal skin); = Erythema barely visible; = Mild erythema; = Moderate erythema; = Severe erythema; = Severe erythema with vesicles or blisters II. Other effects: O : Edema P : Papules (many small, red, solid, elevated lesions, surface of reaction with granular feeling) V : Small vesicles (< 0.5 cm) circumscribed elevations with visible fluid B : Large blister (> 0.5 cm) circumscribed elevations with visible fluidPu : Pustules (inflammatory small elevations containing purulent exudate) H : Hyperpigmentation (increase of the usual pigmentation limited to the patch test area) W : Weeping or oozing (may be a sign of vesiculation or blistering manifested by crusting) S : Extension of the reaction beyond patch-test site (on skin area where no test product was applied) A : Marked reaction to adhesive patch	baseline, 16 weeks
Number of participants with a urinary tract infection (UTI)	Urine samples will be collected to assess the number of patients with UTI.	16 weeks
Change from baseline in patch adhesion score	Patch adhesion to the skin will be evaluated by the caregiver. An estimate of the patch adherence will be provided and graded according to the patch adhesiveness score for the intervals between the scheduled outpatient visits. Following scores should be 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 total score ranges from 1 to 4 where a higher score indicates less adhesion.	baseline, 16 weeks

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 31, 2018
• Primary Completion (Actual): December 31, 2020
• Study Completion (Actual): December 7, 2022

Study Registration Dates

• First Submitted: December 8, 2016
• First Submitted That Met QC Criteria: December 8, 2016
• First Posted (Estimate): December 12, 2016

Study Record Updates

• Last Update Posted (Actual): January 25, 2023
• Last Update Submitted That Met QC Criteria: January 24, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Alzheimer, Rivastigmine
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Neuroprotective Agents; Protective Agents; Cholinesterase Inhibitors; Rivastigmine
• Other Study ID Numbers: CENA713DIN01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No