<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/NCT04473235</url>
  </required_header>
  <id_info>
    <org_study_id>P0541386</org_study_id>
    <nct_id>NCT04473235</nct_id>
  </id_info>
  <brief_title>Better Memory With Literacy Acquisition Later in Life</brief_title>
  <official_title>Better Memory With Literacy Acquisition Later in Life</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Federal University of Minas Gerais</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to discover whether acquiring basic-literacy in adulthood can improve&#xD;
      episodic memory and brain structural and functional connectivity. In a collaborative project&#xD;
      between Brazil and USA, the investigators will use a randomized controlled trial approach to&#xD;
      leverage the level of evidence of the benefits of basic adult-education as a possible&#xD;
      cognitive reserve builder. If successful, the study's findings will be important in shaping&#xD;
      policies targeting increasing access to late-life education to reduce dementia risk.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 11, 2021</start_date>
  <completion_date type="Actual">December 17, 2022</completion_date>
  <primary_completion_date type="Actual">December 17, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Episodic memory improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR-IR) test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Brain connectivity improvement</measure>
    <time_frame>6 months</time_frame>
    <description>Change in hippocampus-prefrontal cortex functional and structural connectivity</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">108</enrollment>
  <condition>Memory Impairment</condition>
  <arm_group>
    <arm_group_label>Literacy training</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-literacy training</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. After 6 months, the groups switch, so the comparator receives the specific reading and writing training, and the intervention group receives the lessons on other themes.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Literacy training</intervention_name>
    <description>Teaching adults how to read and write using the analytical and phonemic method</description>
    <arm_group_label>Literacy training</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Non-Literacy training</intervention_name>
    <description>Attending classes in geography, history, sciences, without receiving the specific training in literacy</description>
    <arm_group_label>Non-literacy training</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Being illiterate (TOFHLA score &lt;53) and availability to participate in the study for at&#xD;
        least 12 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        A) Presence of remarkable cognitive complains and/or decompensated psychiatric illness&#xD;
        (depression and anxiety) and/or current substance abuse such as alcohol and illicit drugs&#xD;
        use.&#xD;
&#xD;
        B) Objective cognitive impairment: score of 2 standard deviations or bellow for age and&#xD;
        education on the Mini-Mental State Evaluation (MMSE) and/or score of 6 or lower on the&#xD;
        delayed recall task from the Brief Cognitive Battery.&#xD;
&#xD;
        C) History of previously diagnosed dyslexia D) Formal MRI contraindications including metal&#xD;
        or claustrophobia. E) Severe structural lesions detected by MRI.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>89 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elisa Resende, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UFMG</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lea T Grinberg, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Federal de Minas Gerais</name>
      <address>
        <city>Belo Horizonte</city>
        <state>Minas Gerais</state>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>July 12, 2020</study_first_submitted>
  <study_first_submitted_qc>July 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>January 11, 2023</last_update_submitted>
  <last_update_submitted_qc>January 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 13, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT04473235
org study id: P0541386
nct id: NCT04473235
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
This study aims to discover whether acquiring basic-literacy in adulthood can improve
      episodic memory and brain structural and functional connectivity. In a collaborative project
      between Brazil and USA, the investigators will use a randomized controlled trial approach to
      leverage the level of evidence of the benefits of basic adult-education as a possible
      cognitive reserve builder. If successful, the study's findings will be important in shaping
      policies targeting increasing access to late-life education to reduce dementia risk.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Double (Participant, Outcomes Assessor)
measure: Episodic memory improvement
time frame: 6 months
description: Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR-IR) test
measure: Brain connectivity improvement
time frame: 6 months
description: Change in hippocampus-prefrontal cortex functional and structural connectivity
arm group label: Literacy training
arm group type: Experimental
description: The basic-literacy training will be given for two hours/day for four days/week for 6 months. At baseline, participants will be randomized into four classes of 30. An expert in adult education will oversee the classes and meet the teachers periodically, and each class will count with a certified and experienced lead teacher and teacher aid. The intervention group will receive literacy training based on analytical and phonemic methods for enabling reading and writing
arm group label: Non-literacy training
arm group type: Active Comparator
description: The comparator group will have access to non-literacy classes offered at the adult school, including geography, history, informatics, and sciences, but no literacy-training, for two hours/day for four days/week for 6 months. After 6 months, the groups switch, so the comparator receives the specific reading and writing training, and the intervention group receives the lessons on other themes.
intervention type: Behavioral
intervention name: Literacy training
description: Teaching adults how to read and write using the analytical and phonemic method
arm group label: Literacy training
intervention type: Behavioral
intervention name: Non-Literacy training
description: Attending classes in geography, history, sciences, without receiving the specific training in literacy
arm group label: Non-literacy training
criteria: 
gender: All
minimum age: 40 Years
maximum age: 89 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elisa Resende, MD, PhD
role: Principal Investigator
affiliation: UFMG
last name: Lea T Grinberg, MD, PhD
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: Brazil
responsible party type: Sponsor
sharing ipd: No