Better Memory With Literacy Acquisition Later in Life

NCT ID: NCT04473235

Last Updated: 2024-07-16

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

108 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-11

Study Completion Date

2022-12-17

Brief Summary

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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.

Detailed Description

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Conditions

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Memory Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Literacy training

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

Non-Literacy training

Intervention Type BEHAVIORAL

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

Interventions

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Literacy training

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

Intervention Type BEHAVIORAL

Non-Literacy training

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Federal University of Minas Gerais

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Elisa Resende, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UFMG

Lea T Grinberg, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, Brazil

Site Status

Countries

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Brazil

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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R21AG069252

Identifier Type: NIH

Identifier Source: secondary_id

View Link

P0541386

Identifier Type: -

Identifier Source: org_study_id

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