A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.

NCT02989402 | Completed Phase 4 Results

• 1 other identifier: CENA713DIN01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 9

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.

Conditions

Alzheimer's Disease

Keywords

Alzheimer, Rivastigmine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change From Baseline in Mini-Mental State Examination (MMSE)

  Baseline, 16 weeks

• Change From Baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) Score

  Baseline, 16 weeks

• Compliance by Caregiver Medication Questionnaire (CMQ) Score

  Week 16

• Number of Participants With a Skin Irritation

  Week 16

• Number of Participants With a Urinary Tract Infection (UTI)

  16 weeks

Study Arms (1)

Rivastigmine patch

EXPERIMENTAL

15 cm\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day

Drug: Rivastigmine

Interventions

Rivastigmine DRUG

15 cm\^2 patch sizes loaded with 27 mg of rivastigmine - one patch per day

Rivastigmine patch

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (9)

Novartis Investigative Site

Bangalore, Karnataka, 560 055, India

Location

Novartis Investigative Site

Bangalore, Karnataka, 560052, India

Location

Novartis Investigative Site

Banglaore, Karnataka, 560052, India

Location

Novartis Investigative Site

Bengaluru, Karnataka, 560005, India

Location

Novartis Investigative Site

Mumbai, Maharashtra, 400 053, India

Location

Novartis Investigative Site

Hyderabad, Telangana, 500082, India

Location

Novartis Investigative Site

Lucknow, Uttar Pradesh, 226003, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700017, India

Location

Novartis Investigative Site

Kolkata, West Bengal, 700054, India

Location

MeSH Terms

Conditions

Alzheimer Disease

Interventions

Rivastigmine

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phenylcarbamates; Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

+ 1 862 778 8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2016
• First Posted: December 12, 2016
• Study Start: December 31, 2018
• Primary Completion: December 7, 2022
• Study Completion: December 8, 2022
• Last Updated: May 31, 2024
• Results First Posted: May 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

IN (9)