Better Memory With Literacy Acquisition Later in Life

NCT04473235 | Completed Results

• 2 other identifiers: P0541386R21AG069252
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

Conditions

Memory Impairment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in Brain Connectivity

  Baseline and 6 months

Study Arms (2)

Literacy training

EXPERIMENTAL

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

Non-literacy training

ACTIVE COMPARATOR

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

Interventions

Literacy training BEHAVIORAL

Teaching adults how to read and write using the analytical and phonemic method

Literacy training

Non-Literacy training BEHAVIORAL

Attending classes in geography, history, sciences, without receiving the specific training in literacy

Non-literacy training

Eligibility Criteria

• Age: 40 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of California, San Francisco: lead
• Federal University of Minas Gerais: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Location

MeSH Terms

Conditions

Memory Disorders

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Elisa de Paula França Resende
• Organization: Universidade Federal de Minas Gerais

elisa.resende@gbhi.org

+55 31 3307 9417

Study Officials

• Elisa Resende, MD, PhD

  UFMG

  PRINCIPAL INVESTIGATOR

• Lea T Grinberg, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2020
• First Posted: July 16, 2020
• Study Start: November 11, 2021
• Primary Completion: December 17, 2022
• Study Completion: December 17, 2022
• Last Updated: July 16, 2024
• Results First Posted: July 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)