- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01978353
Memory Training in Patients With Amnestic Mild Cognitive Impairment
Episodic Memory Training for Face Name Association in Patients With Amnestic Mild Cognitive Impairment: Cognitive Measures and Functional Resonance Magnetic Imaging Outcomes
Preview research reports evidence of cognitive plasticity among individuals with amnestic Mild cognitive Impairment, and small-size studies have suggest that this population can benefit from memory training. This project intends to assess the efficacy of cognitive training in persons with MCI with a randomized controlled design.
The hypothesis is that cognitive training can improve memory performance for persons with amnestic mild cognitive impairment and this improvement can be maintained over time.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Mild Cognitive Impairment (MCI) often represents a transitional state between healthy aging and dementia, being considered a public health problem especially due to the increase of elder population in Brazil and in the World in general. Yet the conclusions of studies on pharmacological treatments for this population are still controversial, making imperative to invest on new efficient therapies such as non pharmacological interventions aimed at memory improvement.
One training mode that has benefited elders is the association between names and faces, which has a compelling clinical relevance considering that one of the main complains among elders is the difficulty in remembering names. However, the exact effects of this kind of training in elders (i.e. the eventual changes in cognition and in brain activation on Magnetic Resonance Imaging) are still unclear.
Therefore, this study aims to verify the effects of memory training (name-face association) compared with control intervention - psychoeducation, in 30 elders with amnestic MCI. We will request the participants with amnestic MCI to submit to a Cerebrospinal Fluid (CSF) in order to improve the accuracy of the diagnosis. Training and psychoeducation will be conducted in 4 sessions (two per week). To assess the effects, we will use cognitive instruments and MRI exams before and after the intervention. Also, one and three months after the conclusion of the training patients will again be submitted to cognitive tests.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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São Paulo, Brazil, 05403-010
- University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Memory Training
Participants receive memory training to facilitate learning and memory of face-name associations
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Participants receive memory training to facilitate learning and memory of face-name associations
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Active Comparator: Psychoeducation
Participants receive information about memory functioning and aging
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Participants receive information about memory functioning and aging
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Changes in memory measures
Time Frame: Baseline and within two weeks after intervention
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Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)
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Baseline and within two weeks after intervention
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Changes in functional magnetic resonance imaging (fMRI)
Time Frame: Baseline and within two weeks after intervention
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fMRI correlates of behavioral performance at face-name task
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Baseline and within two weeks after intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in perception of memory performance and mood
Time Frame: Baseline, within two weeks after intervention
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Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory
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Baseline, within two weeks after intervention
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Changes in memory performance and perception of memory performance over time - follow up
Time Frame: One and three months after intervention
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Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory, Word list learning test and behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)
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One and three months after intervention
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Collaborators and Investigators
Investigators
- Study Director: Cássio Machado de Campos Bottino, M.D., Ph.D, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
- Principal Investigator: Sharon Sanz Simon, Ph.D Student, Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAE: 08223513.3.0000.0068
- 12/51699-1 (Other Grant/Funding Number: São Paulo Research Foundation - FAPESP)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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