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Better Memory With Literacy Acquisition Later in Life

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04473235
Recruitment Status : Not yet recruiting
First Posted : July 16, 2020
Last Update Posted : May 5, 2021
Federal University of Minas Gerais
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Memory Impairment Behavioral: Literacy training Behavioral: Non-Literacy training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Better Memory With Literacy Acquisition Later in Life
Estimated Study Start Date : September 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Literacy training
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
Behavioral: Literacy training
Teaching adults how to read and write using the analytical and phonemic method

Active Comparator: Non-literacy training
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.
Behavioral: Non-Literacy training
Attending classes in geography, history, sciences, without receiving the specific training in literacy

Primary Outcome Measures :
  1. Episodic memory improvement [ Time Frame: 6 months ]
    Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR-IR) test

Secondary Outcome Measures :
  1. Brain connectivity improvement [ Time Frame: 6 months ]
    Change in hippocampus-prefrontal cortex functional and structural connectivity

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   40 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

Being illiterate (TOFHLA score <53) and availability to participate in the study for at least 12 months

Exclusion Criteria:

A) Presence of remarkable cognitive complains and/or decompensated psychiatric illness (depression and anxiety) and/or current substance abuse such as alcohol and illicit drugs use.

B) Objective cognitive impairment: score of 2 standard deviations or bellow for age and education on the Mini-Mental State Evaluation (MMSE) and/or score of 6 or lower on the delayed recall task from the Brief Cognitive Battery.

C) History of previously diagnosed dyslexia D) Formal MRI contraindications including metal or claustrophobia. E) Severe structural lesions detected by MRI.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04473235

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Contact: Lea T Grinberg, MD, PhD +1 415 514-8953

Sponsors and Collaborators
University of California, San Francisco
Federal University of Minas Gerais
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Principal Investigator: Elisa Resende, MD, PhD UFMG
Principal Investigator: Lea T Grinberg, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco Identifier: NCT04473235    
Other Study ID Numbers: P0541386
First Posted: July 16, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No