Memory Training in Patients With Amnestic Mild Cognitive Impairment

Mild Cognitive Impairment Clinical Trial

Official title:

Episodic Memory Training for Face Name Association in Patients With Amnestic Mild Cognitive Impairment: Cognitive Measures and Functional Resonance Magnetic Imaging Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01978353
• Other study ID #: CAAE: 08223513.3.0000.0068
• Secondary ID: 12/51699-1
• Status: Completed
• Phase: N/A
• First received: October 21, 2013
• Last updated: October 23, 2015
• Start date: November 2012
• Est. completion date: October 2015

Study information

• Verified date: October 2015
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cognition Disorders
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Brazil	University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in memory measures	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	No
Primary	Changes in functional magnetic resonance imaging (fMRI)	fMRI correlates of behavioral performance at face-name task	Baseline and within two weeks after intervention	No
Secondary	Changes in perception of memory performance and mood	Multifactorial Memory Questionnaire, Beck Depression Inventory and Beck Anxiety Inventory	Baseline, within two weeks after intervention	No
Secondary	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)	One and three months after intervention	No