Cognitive Training in Patients With MCI Using fMRI

Study Overview
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Brief Summary
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The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

Detailed Description
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We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will also include 30 healthy subjects, over 60 years old, recruited in the community. All the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4 control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will receive cognitive training with alphabet search training and the G6 control group will receive cognitive training with alphabet search training. This will be a longitudinal, randomized, double blind study. MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

Official Title
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Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: Memory Training
* Behavioral: Psychoeducation
* Behavioral: Alphabet search


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Portuguese as native and preferred language; A minimum of 4 years of education; MRI-compatible; Right-handed individuals; Normal corrected vision and hearing; Estimated intelligence average or above (≥ 80 IQ); Amnestic Mild Cognitive Impairment identified by a doctor and neuropsychological tests; Able to give informed consent. Exclusion Criteria: History of neurological disorder; History of serious systemic disease; History of severe mental illness; Current untreated alcohol or substance abuse; Medical conditions that compromise in any way the central nervous system; Presence of visual impairment and / or hearing to preclude cognitive testing; Presence of contraindications to MRI exam; Findings in structural MRI that can interfere with the results of the study

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visual Imaging Training<br>Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions | Behavioral: Memory Training<br> <br> |
| Active Comparator: Psychoeducation<br>Participants will receive information about memory functioning and aging. Intervention: behavioral: Psychoeducation in individual sessions | Behavioral: Psychoeducation<br> <br> |
| Experimental: Alphabet Search<br>Participants will receive alphabet search training. Intervention: Alphabet Search in individual sessions | Behavioral: Alphabet search<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional magnetic resonance imaging (fMRI) | fMRI correlates of behavioral performance | Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance | 
| Changes in memory and language measures | Improvement in Logical Memory Test I and II results and naming tests | Baseline and after 4 weeks of intervention - generalization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in perception of memory performance | Multifactorial Memory Questionnaire | Baseline, within four weeks after intervention |