Trial Outcomes & Findings for Better Memory With Literacy Acquisition Later in Life (NCT NCT04473235)

Last Updated: 2024-07-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

108 participants

Primary outcome timeframe

Baseline and 6 months

Results posted on

2024-07-16

Participant Flow

The assignment of participants to each arm group occured after enrollment. There was no specific event before assigment.

Participant milestones

Participant milestones
Measure	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 Literacy training: 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. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy
Overall Study STARTED	58	50
Overall Study COMPLETED	39	38
Overall Study NOT COMPLETED	19	12

Reasons for withdrawal

Reasons for withdrawal
Measure	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 Literacy training: 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. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy
Overall Study Lost to Follow-up	6	5
Overall Study Declined continuation	2	0
Overall Study Physician Decision	1	1
Overall Study Protocol Violation	10	6

Baseline Characteristics

Better Memory With Literacy Acquisition Later in Life

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Literacy Training n=58 Participants 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 Literacy training: Teaching adults how to read and write using the analytical and phonemic method	Non-literacy Training n=50 Participants 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. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy	Total n=108 Participants Total of all reporting groups
Age, Continuous	58.4 years STANDARD_DEVIATION 9.8 • n=5 Participants	58.4 years STANDARD_DEVIATION 9.7 • n=7 Participants	58.4 years STANDARD_DEVIATION 9.7 • n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants	35 Participants n=7 Participants	77 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	15 Participants n=7 Participants	31 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	58 Participants n=5 Participants	50 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	39 Participants n=5 Participants	39 Participants n=7 Participants	78 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	14 Participants n=5 Participants	7 Participants n=7 Participants	21 Participants n=5 Participants
Region of Enrollment Brazil	58 participants n=5 Participants	50 participants n=7 Participants	108 participants n=5 Participants
Free and cued recall sum of attempts	28.3 units on a scale STANDARD_DEVIATION 7.1 • n=5 Participants	28.4 units on a scale STANDARD_DEVIATION 5.5 • n=7 Participants	28.3 units on a scale STANDARD_DEVIATION 6.3 • n=5 Participants

PRIMARY outcome

Timeframe: Baseline and 6 months

Outcome measures

Outcome measures
Measure	Literacy Training n=39 Participants 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 Literacy training: Teaching adults how to read and write using the analytical and phonemic method	Non-literacy Training n=38 Participants 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. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy
Episodic Memory Improvement	31.8 score on a scale Standard Deviation 5.8	31.3 score on a scale Standard Deviation 5.5

SECONDARY outcome

Timeframe: Baseline and 6 months

Population: Some participants had artifacts in their MRIs that made the researchers not able to interpret the resting state functional MRI. Therefore these participants are not included in the analysis for this outcome.

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.

Outcome measures

Outcome measures
Measure	Literacy Training n=31 Participants 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 Literacy training: Teaching adults how to read and write using the analytical and phonemic method	Non-literacy Training n=32 Participants 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. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy
Change in Brain Connectivity Connectivity between the left hippocampal and left prefrontal cortex	-0.11 unitless Standard Deviation 0.38	0.06 unitless Standard Deviation 0.39
Change in Brain Connectivity Connectivity between the right hippocampal and right prefrontal cortex	-0.11 unitless Standard Deviation 0.42	-0.05 unitless Standard Deviation 0.39

Adverse Events

Literacy Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Non-literacy Training

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Literacy Training n=58 participants at risk 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 Literacy training: Teaching adults how to read and write using the analytical and phonemic method	Non-literacy Training n=50 participants at risk 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. After 6 months, the groups switch, so the comparator receives the specific reading and writing training, and the intervention group receives the lessons on other themes. Non-Literacy training: Attending classes in geography, history, sciences, without receiving the specific training in literacy
Nervous system disorders Headache	1.7% 1/58 • Number of events 1 • 6 months	0.00% 0/50 • 6 months
Nervous system disorders Claustrofobia	0.00% 0/58 • 6 months	4.0% 2/50 • Number of events 2 • 6 months

Additional Information

Elisa de Paula França Resende

Universidade Federal de Minas Gerais

Phone: +55 31 3307 9417

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place