Better Memory With Literacy Acquisition Later in Life

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.

Study Overview

• Status: Completed
• Conditions: Memory Impairment
• Intervention / Treatment: Behavioral: Literacy training; Behavioral: Non-Literacy training

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Minas Gerais
    • Belo Horizonte, Minas Gerais, Brazil
      • Universidade Federal De Minas Gerais

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.	Behavioral: Non-Literacy training; Attending classes in geography, history, sciences, without receiving the specific training in literacy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Episodic Memory Improvement	Change in free recall sum-of-attempts of the Free and Cued Selective Reminding with Immediate Recall (FCSR) test. The Free and Cued Selective Reminding Test (FCSRT) is an episodic memory test. First, the participant learns 16 figures, 4 each time, with the help of semantic cues provided by the examiner. After that, the participant recalls the figures 3 times, with a distraction activity between each attempt (counting 20 to 1 backwards). The sum of each immediate free recall is called sum of attempts. It ranges from 0 (the participant does not recall any figure in three attempts) to 48 (the participant recalls all the figures). The higher the score, the better the participant's episodic memory.	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brain Connectivity	The intrinsic functional connectivity will be measured using the BOLD (blood oxygen level dependent) that is calculated through resting state functional MRIs that will be performed at baseline and at 6 months follow up. After preprocessing the images and accounting for potential cofounders (head motion signal, cerebral spinal signal, physiological signal and white matter signal), the BOLD signal is measured and coregistered in T1 images for anatomical correspondence of the signal. Then, a seed is placed in the hippocampus and the BOLD signal between the hippocampus and the prefrontal cortex is calculated at baseline and at 6 months follow up. The higher the value, the more the regions are connected. Change in the intrinsic functional connectivity between the hippocampus and the prefrontal cortex.	Baseline and 6 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: National Institute on Aging (NIA); Federal University of Minas Gerais
• Investigators: Principal Investigator: Elisa Resende, MD, PhD, UFMG; Principal Investigator: Lea T Grinberg, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2021
• Primary Completion (Actual): December 17, 2022
• Study Completion (Actual): December 17, 2022

Study Registration Dates

• First Submitted: July 12, 2020
• First Submitted That Met QC Criteria: July 12, 2020
• First Posted (Actual): July 16, 2020

Study Record Updates

• Last Update Posted (Actual): July 16, 2024
• Last Update Submitted That Met QC Criteria: June 21, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: P0541386; R21AG069252 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No