<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02989402</url>
  </required_header>
  <id_info>
    <org_study_id>CENA713DIN01</org_study_id>
    <nct_id>NCT02989402</nct_id>
  </id_info>
  <brief_title>A Phase IV Study to Evaluate Safety, Tolerability and Effectiveness of Rivastigmine Patch 15cm2 in Patients With Severe Dementia of the Alzheimer's Type.</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Novartis Pharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Novartis</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multicenter, prospective, phase IV study evaluating safety, tolerability and&#xD;
      effectiveness of rivastigmine 27 mg -15 cm2 transdermal patch prescribed in patients with&#xD;
      severe dementia of the Alzheimer's type as per discretion of treating physician.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 31, 2018</start_date>
  <completion_date type="Actual">December 7, 2022</completion_date>
  <primary_completion_date type="Actual">December 31, 2020</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of participants with Adverse events as a measure of Safety and tolerability</measure>
    <time_frame>16 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Mini-Mental State Examination (MMSE</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory - Severe Impairment Version (ADCS-ADL SIV) score</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mean Caregiver Medication Questionnaire (CMQ) score</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>The total compliance is rated on an 10 point scale: 0 = &quot;never took the medication as prescribed&quot;; maximum of 10 = &quot;always took the medication as prescribed.&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a skin irritation</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>The following score system will be used to assess skin irritation:&#xD;
I. Dermal response:&#xD;
0 = No erythema (normal skin)&#xD;
= Erythema barely visible&#xD;
= Mild erythema&#xD;
= Moderate erythema&#xD;
= Severe erythema&#xD;
= Severe erythema with vesicles or blisters&#xD;
II. Other effects:&#xD;
O : Edema P : Papules (many small, red, solid, elevated lesions, surface of reaction with granular feeling) V : Small vesicles (&lt; 0.5 cm) circumscribed elevations with visible fluid B : Large blister (&gt; 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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of participants with a urinary tract infection (UTI)</measure>
    <time_frame>16 weeks</time_frame>
    <description>Urine samples will be collected to assess the number of patients with UTI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in patch adhesion score</measure>
    <time_frame>baseline, 16 weeks</time_frame>
    <description>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.&#xD;
Following scores should be used to capture comments relating to patch adhesion:&#xD;
0 = 90 % adhered (essentially no lift off of the skin)&#xD;
= 75% to &lt; 90% adhered (some edges only lifting off of the skin)&#xD;
= 50% to &lt; 75% adhered (less than half of the patch lifting off the skin)&#xD;
= &lt; 50% adhered but not detached (more than half the system lifting off of the skin without falling off)&#xD;
= the patch was completely detached. The total score ranges from 1 to 4 where a higher score indicates less adhesion.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Alzheimer's Disease</condition>
  <arm_group>
    <arm_group_label>Rivastigmine patch</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>15 cm2 patch sizes loaded with 27 mg of rivastigmine</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rivastigmine</intervention_name>
    <description>15 cm2 patch sizes loaded with 27 mg of rivastigmine</description>
    <arm_group_label>Rivastigmine patch</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients willing to participate in the study by providing written informed consent.&#xD;
&#xD;
          2. Patients diagnosed with severe dementia secondary to Alzheimer's disease (AD) 3&#xD;
             .Patient's prescribed with rivastigmine 27mg -15 cm2 transdermal patch as per&#xD;
             discretion of treating physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Contraindication as per PI&#xD;
&#xD;
          2. Patients simultaneously participating in other studies&#xD;
&#xD;
          3. Use of other investigational drugs within 5 half-lives of enrollment, or within 30&#xD;
             days (for small molecules) /until the expected PD effect has returned to baseline (for&#xD;
             biologics)], whichever is longer.&#xD;
&#xD;
          4. History of hypersensitivity to any of the study drugs or to drugs of similar chemical&#xD;
             classes&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Novartis Pharmaceuticals</last_name>
    <role>Study Director</role>
    <affiliation>Novartis Pharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560 055</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bangalore</city>
        <state>Karnataka</state>
        <zip>560052</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Banglaore</city>
        <state>Karnataka</state>
        <zip>560052</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Bengaluru</city>
        <state>Karnataka</state>
        <zip>560005</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Mumbai</city>
        <state>Maharashtra</state>
        <zip>400 053</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500082</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Lucknow</city>
        <state>Uttar Pradesh</state>
        <zip>226003</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700 107</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700017</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novartis Investigative Site</name>
      <address>
        <city>Kolkata</city>
        <state>West Bengal</state>
        <zip>700054</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 8, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 12, 2016</study_first_posted>
  <last_update_submitted>January 24, 2023</last_update_submitted>
  <last_update_submitted_qc>January 24, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Alzheimer, Rivastigmine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
    <mesh_term>Dementia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rivastigmine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.&#xD;
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02989402
org study id: CENA713DIN01
nct id: NCT02989402
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of participants with Adverse events as a measure of Safety and tolerability
time frame: 16 weeks
measure: Change from baseline in Mini-Mental State Examination (MMSE
time frame: baseline, 16 weeks
description: 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
measure: 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
description: 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.
measure: Mean Caregiver Medication Questionnaire (CMQ) score
time frame: baseline, 16 weeks
description: 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."
measure: Number of participants with a skin irritation
time frame: baseline, 16 weeks
description: 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
measure: Number of participants with a urinary tract infection (UTI)
time frame: 16 weeks
description: Urine samples will be collected to assess the number of patients with UTI.
measure: Change from baseline in patch adhesion score
time frame: baseline, 16 weeks
description: 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.
arm group label: Rivastigmine patch
arm group type: Experimental
description: 15 cm2 patch sizes loaded with 27 mg of rivastigmine
intervention type: Drug
intervention name: Rivastigmine
description: 15 cm2 patch sizes loaded with 27 mg of rivastigmine
arm group label: Rivastigmine patch
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Novartis Pharmaceuticals
role: Study Director
affiliation: Novartis Pharmaceuticals
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: India
responsible party type: Sponsor
mesh term: Alzheimer Disease
mesh term: Dementia
mesh term: Rivastigmine
sharing ipd: Yes
ipd 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