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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04473235
Other study ID # P0541386
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 11, 2021
Est. completion date December 17, 2022

Study information

Verified date January 2023
Source University of California, San Francisco
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date December 17, 2022
Est. primary completion date December 17, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 40 Years to 89 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Literacy training
Teaching adults how to read and write using the analytical and phonemic method
Non-Literacy training
Attending classes in geography, history, sciences, without receiving the specific training in literacy

Locations

Country Name City State
Brazil Universidade Federal de Minas Gerais Belo Horizonte Minas Gerais

Sponsors (2)

Lead Sponsor Collaborator
University of California, San Francisco Federal University of Minas Gerais

Country where clinical trial is conducted

Brazil, 

Outcome

Type Measure Description Time frame Safety issue
Primary Episodic memory improvement Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR-IR) test 6 months
Secondary Brain connectivity improvement Change in hippocampus-prefrontal cortex functional and structural connectivity 6 months
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