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Memory Training in Patients With Amnestic Mild Cognitive Impairment

Primary Purpose

Mild Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Memory Training
Psychoeducation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Dementia, Alzheimer's disease, Memory Training, Cognitive Training, Cognitive Rehabilitation, Neuropsychological Rehabilitation

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Memory Training

Psychoeducation

Arm Description

Participants receive memory training to facilitate learning and memory of face-name associations

Participants receive information about memory functioning and aging

Outcomes

Primary Outcome Measures

Changes in memory measures
Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)
Changes in functional magnetic resonance imaging (fMRI)
fMRI correlates of behavioral performance at face-name task

Secondary Outcome Measures

Changes in perception of memory performance and mood
Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory
Changes in memory performance and perception of memory performance over time - follow up
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)

Full Information

First Posted
October 21, 2013
Last Updated
October 23, 2015
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01978353
Brief Title
Memory Training in Patients With Amnestic Mild Cognitive Impairment
Official Title
Episodic Memory Training for Face Name Association in Patients With Amnestic Mild Cognitive Impairment: Cognitive Measures and Functional Resonance Magnetic Imaging Outcomes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
November 2012 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Mild cognitive impairment, Dementia, Alzheimer's disease, Memory Training, Cognitive Training, Cognitive Rehabilitation, Neuropsychological Rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Memory Training
Arm Type
Experimental
Arm Description
Participants receive memory training to facilitate learning and memory of face-name associations
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Participants receive information about memory functioning and aging
Intervention Type
Behavioral
Intervention Name(s)
Memory Training
Intervention Description
Participants receive memory training to facilitate learning and memory of face-name associations
Intervention Type
Behavioral
Intervention Name(s)
Psychoeducation
Intervention Description
Participants receive information about memory functioning and aging
Primary Outcome Measure Information:
Title
Changes in memory measures
Description
Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)
Time Frame
Baseline and within two weeks after intervention
Title
Changes in functional magnetic resonance imaging (fMRI)
Description
fMRI correlates of behavioral performance at face-name task
Time Frame
Baseline and within two weeks after intervention
Secondary Outcome Measure Information:
Title
Changes in perception of memory performance and mood
Description
Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory
Time Frame
Baseline, within two weeks after intervention
Title
Changes in memory performance and perception of memory performance over time - follow up
Description
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)
Time Frame
One and three months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cássio Machado de Campos Bottino, M.D., Ph.D
Organizational Affiliation
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sharon Sanz Simon, Ph.D Student
Organizational Affiliation
Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
City
São Paulo
ZIP/Postal Code
05403-010
Country
Brazil

12. IPD Sharing Statement

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Memory Training in Patients With Amnestic Mild Cognitive Impairment

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