Memory Impairment
Conditions
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.
Interventions
BEHAVIORALLiteracy training
Teaching adults how to read and write using the analytical and phonemic method
BEHAVIORALNon-Literacy training
Attending classes in geography, history, sciences, without receiving the specific training in literacy
Sponsors
Federal University of Minas Gerais
National Institute on Aging (NIA)
University of California, San Francisco
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 89 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Brazil
Participant flow
Pre-assignment details
The assignment of participants to each arm group occured after enrollment. There was no specific event before assigment.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 58 |
| 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 | 50 |
| Total | 108 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Declined continuation | 2 | 0 |
| Overall Study | Lost to Follow-up | 6 | 5 |
| Overall Study | Physician Decision | 1 | 1 |
| Overall Study | Protocol Violation | 10 | 6 |
Baseline characteristics
| Characteristic | Literacy Training | Non-literacy Training | Total |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 9.8 | 58.4 years STANDARD_DEVIATION 9.7 | 58.4 years STANDARD_DEVIATION 9.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 58 Participants | 50 Participants | 108 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Free and cued recall sum of attempts | 28.3 units on a scale STANDARD_DEVIATION 7.1 | 28.4 units on a scale STANDARD_DEVIATION 5.5 | 28.3 units on a scale STANDARD_DEVIATION 6.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 39 Participants | 39 Participants | 78 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants | 7 Participants | 21 Participants |
| Race (NIH/OMB) White | 5 Participants | 4 Participants | 9 Participants |
| Region of Enrollment Brazil | 58 participants | 50 participants | 108 participants |
| Sex: Female, Male Female | 42 Participants | 35 Participants | 77 Participants |
| Sex: Female, Male Male | 16 Participants | 15 Participants | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 50 |
| other Total, other adverse events | 1 / 58 | 2 / 50 |
| serious Total, serious adverse events | 0 / 58 | 0 / 50 |
Outcome results
Primary
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.
Time frame: Baseline and 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Literacy Training | Episodic Memory Improvement | 31.8 score on a scale | Standard Deviation 5.8 |
| Non-literacy Training | Episodic Memory Improvement | 31.3 score on a scale | Standard Deviation 5.5 |
p-value: 0.531t-test, 2 sided
Secondary
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Literacy Training | Change in Brain Connectivity | Connectivity between the left hippocampal and left prefrontal cortex | -0.11 unitless | Standard Deviation 0.38 |
| Literacy Training | Change in Brain Connectivity | Connectivity between the right hippocampal and right prefrontal cortex | -0.11 unitless | Standard Deviation 0.42 |
| Non-literacy Training | Change in Brain Connectivity | Connectivity between the left hippocampal and left prefrontal cortex | 0.06 unitless | Standard Deviation 0.39 |
| Non-literacy Training | Change in Brain Connectivity | Connectivity between the right hippocampal and right prefrontal cortex | -0.05 unitless | Standard Deviation 0.39 |
Comparison: Difference in the connectivity between the left hippocampus and left prefrontal cortex.p-value: 0.627t-test, 2 sided
Comparison: Difference in the connectivity between the right hippocampus and right prefrontal cortex.p-value: 0.12t-test, 2 sided