Memory Training in Patients With Amnestic Mild Cognitive Impairment

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by University of Sao Paulo General Hospital
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT01978353
First received: October 21, 2013
Last updated: October 31, 2013
Last verified: October 2013
  Purpose

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.


Condition Intervention
Mild Cognitive Impairment
Behavioral: Memory Training
Behavioral: Psychoeducation

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Episodic Memory Training for Face Name Association in Patients With Amnestic Mild Cognitive Impairment: Cognitive Measures and Functional Resonance Magnetic Imaging Outcomes

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

Primary Outcome Measures:
  • Changes in memory measures [ Time Frame: Baseline and within two weeks after intervention ] [ Designated as safety issue: No ]
    Word list learning test, behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)

  • Changes in functional nagnetic resonance imaging (fMRI) [ Time Frame: Baseline and within two weeks after intervention ] [ Designated as safety issue: No ]
    fMRI correlates of behavioral performance at face-name task


Secondary Outcome Measures:
  • Changes in perception of memory performance and mood [ Time Frame: Baseline, within two weeks, one and three months after intervention ] [ Designated as safety issue: No ]
    Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory

  • Changes in memory performance over time - follow up [ Time Frame: One and three months after intervention ] [ Designated as safety issue: No ]
    Word list learning test and behavioral performance on experimental stimuli - face-name memory task (accuracy, reaction time, confidence level)


Estimated Enrollment: 30
Study Start Date: November 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Memory Training
Participants receive memory training to facilitate learning and memory of face-name associations
Behavioral: Memory Training
Participants receive memory training to facilitate learning and memory of face-name associations
Active Comparator: Psychoeducation
Participants receive information about memory functioning and aging
Behavioral: Psychoeducation
Participants receive information about memory functioning and aging

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.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01978353

Contacts
Contact: Sharon Sanz Simon, Researcher (5511) 2661-6973 sharon.sanzsimon@gmail.com

Locations
Brazil
University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry Recruiting
São Paulo, Brazil, 05403-010
Contact: Sharon Sanz Simon, Researcher    (5511) 2661-6973    sharon.sanzsimon@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
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
  More Information

No publications provided

Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT01978353     History of Changes
Other Study ID Numbers: CAAE: 08223513.3.0000.0068, 12/51699-1
Study First Received: October 21, 2013
Last Updated: October 31, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo General Hospital:
Mild cognitive impairment
Dementia
Alzheimer's disease
Memory Training
Cognitive Training
Cognitive Rehabilitation
Neuropsychological Rehabilitation

Additional relevant MeSH terms:
Cognition Disorders
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014