<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/NCT02260141</url>
  </required_header>
  <id_info>
    <org_study_id>PAN- ALZ001</org_study_id>
    <nct_id>NCT02260141</nct_id>
  </id_info>
  <brief_title>Treating Alzheimer's and Dementia With D-ribose</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Practitioners Alliance Network</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Practitioners Alliance Network</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To study the effectiveness of d-ribose in treating Alzheimer's and Dementia&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin&#xD;
      resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm&#xD;
      3 X day for 8 weeks to monitor outcomes in a pilot study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    unable to get adequate enrollment&#xD;
  </why_stopped>
  <start_date type="Actual">September 2014</start_date>
  <completion_date type="Actual">October 2017</completion_date>
  <primary_completion_date type="Actual">October 2017</primary_completion_date>
  <phase>N/A</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>
    <intervention_model_description>Single arm pilot study using ribose for alzheimers</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>ADAS-ADL</measure>
    <time_frame>2 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">3</enrollment>
  <condition>Alzheimers</condition>
  <condition>Dementia</condition>
  <arm_group>
    <arm_group_label>Treatment with d-ribose</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Treatment with ribose 5 gm TID</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>d-ribose</intervention_name>
    <description>giving ribose in those with a diagnosis of Alzheimer's and/or dementia</description>
    <arm_group_label>Treatment with d-ribose</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A diagnosis of Alzheimer's and/or dementia with a Mini Mental Status Exam ( MMSE)&#xD;
             score over 12 or being ambulatory and able to travel outside the home with assistance.&#xD;
&#xD;
          -  Must have a caregiver living with them.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Overt and severe causes of secondary dementia such as metastatic brain cancers, or&#xD;
             severe overt infectious encephalopathies or severe autoimmune illness.&#xD;
&#xD;
          -  Also, severe life threatening illnesses which would make them unlikely to be alive&#xD;
             after 6-12 months.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>PAN</name>
      <address>
        <city>Kailua</city>
        <state>Hawaii</state>
        <zip>96740</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 5, 2014</study_first_submitted>
  <study_first_submitted_qc>October 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>May 6, 2020</last_update_submitted>
  <last_update_submitted_qc>May 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 8, 2020</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>Dementia</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/NCT02260141
org study id: PAN- ALZ001
nct id: NCT02260141
lead sponsor: 
has dmc: Yes
To study the effectiveness of d-ribose in treating Alzheimer's and Dementia
Clinical experience and the pathophysiology of Alzheimer's, including neuronal insulin
      resistance, suggests that ribose improves clinical outcomes. This study will add ribose 5 gm
      3 X day for 8 weeks to monitor outcomes in a pilot study.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm pilot study using ribose for alzheimers
primary purpose: Treatment
masking: None (Open Label)
measure: ADAS-ADL
time frame: 2 months
arm group label: Treatment with d-ribose
arm group type: Experimental
description: Treatment with ribose 5 gm TID
intervention type: Dietary Supplement
intervention name: d-ribose
description: giving ribose in those with a diagnosis of Alzheimer's and/or dementia
arm group label: Treatment with d-ribose
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Dementia
sharing ipd: No