<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/NCT01669876</url>
  </required_header>
  <id_info>
    <org_study_id>RCP-009</org_study_id>
    <nct_id>NCT01669876</nct_id>
  </id_info>
  <brief_title>Study to Evaluate Dietary Supplementation With a Version of Anatabloc(R) in Subjects With Alzheimer's Disease</brief_title>
  <acronym>ASAP</acronym>
  <official_title>3-Month, Single Site or Multi-Site, Double Blind, Randomized, Placebo-Controlled, Parallel-Group Trial to Evaluate the Safety Tolerability and Potential Effects of the Dietary Supplement Anatabloc(R) in Subjects With Alzheimer's Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rock Creek Pharmaceuticals, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Roskamp Institute Inc.</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rock Creek Pharmaceuticals, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on&#xD;
      blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's&#xD;
      Disease (AD) in subjects with mild to moderate AD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Administrative status of active ingredient anatabine&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <phase>Phase 2</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of subjects experiencing adverse effects when using the supplement</measure>
    <time_frame>3 months</time_frame>
    <description>Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Measured changes in blood markers of AD</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in blood levels of amyloid beta (Aβ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in global or functional measures of AD in subjects during the course of the study</measure>
    <time_frame>3 months</time_frame>
    <description>Changes in subject's scores in global and functional measures of AD during the course of the study</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">85</enrollment>
  <condition>Alzheimer Disease</condition>
  <arm_group>
    <arm_group_label>Dietary Supplement: Anatabloc(R)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo, as mint-flavored lozenge, to be taken 2-3 times each day</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Anatabloc(R)</intervention_name>
    <description>Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day</description>
    <arm_group_label>Dietary Supplement: Anatabloc(R)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 65 years old.&#xD;
&#xD;
          -  Have a diagnosis of probable AD or a concurrent diagnosis of probable AD and possible&#xD;
             or probable vascular dementia.&#xD;
&#xD;
          -  Score 16 or more on the Mini-Mental State Examination (MMSE).&#xD;
&#xD;
          -  Otherwise stable medical history and general health.&#xD;
&#xD;
          -  Weigh between 45 kg and 120 kg inclusive.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Have contra-indications, allergy, or sensitivity to the study products or their&#xD;
             components.&#xD;
&#xD;
          -  Be currently taking any of the following medications: systemic (oral or injectable)&#xD;
             glucocorticoids; interferon-alpha; anti-CD20 antibody (e.g., rituximab); or&#xD;
             anti-CTLA-4 antibody (e.g., ipilimumab).&#xD;
&#xD;
          -  Be a current smoker or smokeless tobacco user.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>65 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>A Keegan, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Roskamp Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Roskamp Institute</name>
      <address>
        <city>Sarasota</city>
        <state>Florida</state>
        <zip>34243</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2015</verification_date>
  <study_first_submitted>August 17, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>April 28, 2015</last_update_submitted>
  <last_update_submitted_qc>April 28, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 30, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Randomized</keyword>
  <keyword>Double-Blind</keyword>
  <keyword>Dietary Supplements</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Alzheimer Disease</mesh_term>
  </condition_browse>
  <!-- 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/NCT01669876
org study id: RCP-009
nct id: NCT01669876
lead sponsor: 
collaborator: 
has dmc: No
To explore whether dietary supplementation with a version of Anatabloc(R) exerts an effect on
      blood levels of amyloid beta (Aβ), or impacts global or functional measures of Alzheimer's
      Disease (AD) in subjects with mild to moderate AD.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Number of subjects experiencing adverse effects when using the supplement
time frame: 3 months
description: Collected data on the numbers and types of adverse effects among subject individuals with mild to moderate Alzheimer's disease (AD).
measure: Measured changes in blood markers of AD
time frame: 3 months
description: Changes in blood levels of amyloid beta (Aβ)
measure: Changes in global or functional measures of AD in subjects during the course of the study
time frame: 3 months
description: Changes in subject's scores in global and functional measures of AD during the course of the study
arm group label: Dietary Supplement: Anatabloc(R)
arm group type: Active Comparator
description: Study product, as mint-flavored lozenge (3 mg anatabine per lozenge) to be taken 2-3 times each day
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo, as mint-flavored lozenge, to be taken 2-3 times each day
intervention type: Dietary Supplement
intervention name: Anatabloc(R)
description: Dietary supplement Anatabloc(R), as a mint-flavored lozenge, to be taken 2-3 times each day
arm group label: Dietary Supplement: Anatabloc(R)
intervention type: Dietary Supplement
intervention name: Placebo
description: Placebo, as a mint-flavored lozenge, to be taken 2-3 times each day
arm group label: Placebo
criteria: 
gender: All
minimum age: 65 Years
maximum age: 90 Years
healthy volunteers: No
last name: A Keegan, MD
role: Principal Investigator
affiliation: Roskamp Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Alzheimer Disease