<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/NCT02991235</url>
  </required_header>
  <id_info>
    <org_study_id>BIO-PRJ-2015-01</org_study_id>
    <nct_id>NCT02991235</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of PRJ212 to Improve the Memory of Patients With Mild Severity Alzheimer's Disease</brief_title>
  <official_title>Evaluation of the Efficacy and Safety of PRJ212 on Improving the Memory of Patients With Mild Severity Alzheimer's Disease: A 6-month Randomized, Double-blind and Placebo-controlled, Followed by a 6-month Open Label Extension Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bioiberica</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bioiberica</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label&#xD;
      extension study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease,&#xD;
      according to the diagnostic criteria established by the National Institute of Neurological&#xD;
      and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders&#xD;
      Associations (NINCDS-ADRDA).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).</measure>
    <time_frame>Comparison of the R-BANS score, from baseline to 6 months.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).</measure>
    <time_frame>Comparison of the WMS score, from baseline to 6 months.</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).</measure>
    <time_frame>Comparison of the total memory composite score, from baseline to 6 months.</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>PRJ212</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PRJ212 is a nutritional product with active food ingredients.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo is like PRJ212 without active food ingredients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>PRJ212</intervention_name>
    <description>6 capsules of study product will be taken daily and orally.</description>
    <arm_group_label>PRJ212</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>6 capsules of study product will be taken daily and orally.</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients aged from 60 to 85 years.&#xD;
&#xD;
          -  Patients with a diagnosis of probable or possible Alzheimer's disease according to the&#xD;
             NINCDS-ADRDA.&#xD;
&#xD;
          -  Patients with mild Alzheimer's disease according to MMSE.&#xD;
&#xD;
          -  Patients with ability to ingest oral medication.&#xD;
&#xD;
          -  Patients able to undergo a MRI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding women or planning a pregnancy during the study.&#xD;
&#xD;
          -  Patients and caregivers unwilling or unable to perform cognitive testing.&#xD;
&#xD;
          -  Patients taking part in an interventional clinical trial.&#xD;
&#xD;
          -  Patients who have a risk of non-compliance to the study procedures.&#xD;
&#xD;
          -  Patients with clinical or significant laboratory abnormalities.&#xD;
&#xD;
          -  Patients treated with concomitant treatment or food supplements which could interfere&#xD;
             with evaluation criteria.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>60 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Martinez</last_name>
    <role>Study Director</role>
    <affiliation>Bioiberica, S.A.</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fundació ACE</name>
      <address>
        <city>Barcelona</city>
        <zip>08028</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>November 29, 2016</study_first_submitted>
  <study_first_submitted_qc>December 12, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 13, 2016</study_first_posted>
  <last_update_submitted>January 18, 2018</last_update_submitted>
  <last_update_submitted_qc>January 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02991235
org study id: BIO-PRJ-2015-01
nct id: NCT02991235
lead sponsor: 
has dmc: No
A 6-month randomized, double-blind and placebo-controlled, followed by a 6-month open label
      extension study.
Men and women from 60 to 85 years old with diagnosis of mild severity Alzheimer's disease,
      according to the diagnostic criteria established by the National Institute of Neurological
      and Communicative Disorders and Stroke and Alzheimer's Disease and Related Disorders
      Associations (NINCDS-ADRDA).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Efficacy of PRJ212 versus placebo on the memory measured by Repeatable Battery for the Assessment of Neuropsychological Status (R-BANS).
time frame: Comparison of the R-BANS score, from baseline to 6 months.
measure: Efficacy of PRJ212 versus placebo on the memory measured by Wechsler Memory Scale (WMS).
time frame: Comparison of the WMS score, from baseline to 6 months.
measure: Efficacy of PRJ212 versus placebo on the memory measured by memory composite (R-BANS+WMS).
time frame: Comparison of the total memory composite score, from baseline to 6 months.
arm group label: PRJ212
arm group type: Experimental
description: PRJ212 is a nutritional product with active food ingredients.
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo is like PRJ212 without active food ingredients.
intervention type: Dietary Supplement
intervention name: PRJ212
description: 6 capsules of study product will be taken daily and orally.
arm group label: PRJ212
intervention type: Dietary Supplement
intervention name: Placebo
description: 6 capsules of study product will be taken daily and orally.
arm group label: Placebo
criteria: 
gender: All
minimum age: 60 Years
maximum age: 85 Years
healthy volunteers: No
last name: Martinez
role: Study Director
affiliation: Bioiberica, S.A.
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Alzheimer Disease
sharing ipd: No