Memory Training in Patients With Amnestic Mild Cognitive Impairment

October 23, 2015 updated by: University of Sao Paulo General Hospital

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

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

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • São Paulo, Brazil, 05403-010
        • University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Memory Training
Participants receive memory training to facilitate learning and memory of face-name associations
Participants receive memory training to facilitate learning and memory of face-name associations
Active Comparator: Psychoeducation
Participants receive information about memory functioning and aging
Participants receive information about memory functioning and aging

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in memory measures
Time Frame: Baseline and within two weeks after intervention
Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)
Baseline and within two weeks after intervention
Changes in functional magnetic resonance imaging (fMRI)
Time Frame: Baseline and within two weeks after intervention
fMRI correlates of behavioral performance at face-name task
Baseline and within two weeks after intervention

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
Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory
Baseline, within two weeks after intervention
Changes in memory performance and perception of memory performance over time - follow up
Time Frame: One and three months after intervention
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)
One and three months after intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

October 21, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (Estimate)

November 7, 2013

Study Record Updates

Last Update Posted (Estimate)

October 26, 2015

Last Update Submitted That Met QC Criteria

October 23, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

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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