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

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ClinicalTrials.gov Identifier: NCT02989402
Recruitment Status : Recruiting
First Posted : December 12, 2016
Last Update Posted : May 14, 2021
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Rivastigmine Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : December 31, 2018
Actual Primary Completion Date : October 30, 2020
Estimated Study Completion Date : January 1, 2022


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




Primary Outcome Measures :
  1. Number of participants with Adverse events as a measure of Safety and tolerability [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Change from baseline in Mini-Mental State Examination (MMSE [ Time Frame: baseline, 16 weeks ]
    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

  2. Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score [ Time Frame: baseline, 16 weeks ]
    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.

  3. Mean Caregiver Medication Questionnaire (CMQ) score [ Time Frame: baseline, 16 weeks ]
    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."

  4. Number of participants with a skin irritation [ Time Frame: baseline, 16 weeks ]

    The following score system will be used to assess skin irritation:

    I. Dermal response:

    0 = No erythema (normal skin)

    1. = Erythema barely visible
    2. = Mild erythema
    3. = Moderate erythema
    4. = Severe erythema
    5. = 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


  5. Number of participants with a urinary tract infection (UTI) [ Time Frame: 16 weeks ]
    Urine samples will be collected to assess the number of patients with UTI.

  6. Change from baseline in patch adhesion score [ Time Frame: baseline, 16 weeks ]

    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)

    1. = 75% to < 90% adhered (some edges only lifting off of the skin)
    2. = 50% to < 75% adhered (less than half of the patch lifting off the skin)
    3. = < 50% adhered but not detached (more than half the system lifting off of the skin without falling off)
    4. = the patch was completely detached. The total score ranges from 1 to 4 where a higher score indicates less adhesion.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02989402


Contacts
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Contact: Novartis Pharmaceuticals +41613241111 Trialandresults.registries@novartis.com
Contact: Novartis Pharmaceuticals Trialandresults.registries@novartis.com

Locations
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India
Novartis Investigative Site Recruiting
Bangalore, Karnataka, India, 560 055
Novartis Investigative Site Recruiting
Bangalore, Karnataka, India, 560052
Novartis Investigative Site Recruiting
Banglaore, Karnataka, India, 560052
Novartis Investigative Site Recruiting
Bengaluru, Karnataka, India, 560005
Novartis Investigative Site Recruiting
Mumbai, Maharashtra, India, 400 053
Novartis Investigative Site Recruiting
Hyderabad, Telangana, India, 500082
Novartis Investigative Site Recruiting
Lucknow, Uttar Pradesh, India, 226003
Novartis Investigative Site Recruiting
Kolkata, West Bengal, India, 700 107
Sponsors and Collaborators
Novartis Pharmaceuticals
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02989402    
Other Study ID Numbers: CENA713DIN01
First Posted: December 12, 2016    Key Record Dates
Last Update Posted: May 14, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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


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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Alzheimer, Rivastigmine
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Rivastigmine
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Neuroprotective Agents
Protective Agents