Better Memory With Literacy Acquisition Later in Life

Not Applicable

Completed

• Conditions: Memory Impairment
• Interventions: Behavioral: Non-Literacy training; Behavioral: Literacy training

• Registration Number: NCT04473235
• Lead Sponsor: 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.

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study First Submitted: 2020-07-12
• Study First Submitted QC: 2020-07-12
• Study First Posted: 2020-07-16
• Study Start: 2021-11-11
• Primary Completion: 2022-12-17
• Study Completion: 2022-12-17
• Results First Submitted: 2024-03-25
• Status Verified: 2024-06
• Results First Submitted QC: 2024-06-21
• Last Update Submitted: 2024-06-21
• Results First Posted: 2024-07-16
• Last Update Posted: 2024-07-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

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

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-literacy training	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.
Literacy training	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

Primary Outcome Measures

Name	Time	Method
Episodic Memory Improvement	Baseline and 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Change in Brain Connectivity	Baseline and 6 months	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.

Trial Locations

Locations (1)

Universidade Federal de Minas Gerais; 🇧🇷 Belo Horizonte, Minas Gerais, Brazil