Memory Training in Patients With Amnestic Mild Cognitive Impairment

NCT ID: NCT01978353

Last Updated: 2015-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2015-10-31

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.

Conditions

Mild Cognitive Impairment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Memory Training

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

Group Type: EXPERIMENTAL

Memory Training

Intervention Type: BEHAVIORAL

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

Psychoeducation

Participants receive information about memory functioning and aging

Group Type: ACTIVE_COMPARATOR

Psychoeducation

Intervention Type: BEHAVIORAL

Participants receive information about memory functioning and aging

Interventions

Memory Training

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

Intervention Type: BEHAVIORAL

Psychoeducation

Participants receive information about memory functioning and aging

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Cássio Machado de Campos Bottino, M.D., Ph.D

Role: STUDY_DIRECTOR

Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

Sharon Sanz Simon, Ph.D Student

Role: PRINCIPAL_INVESTIGATOR

Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine

Locations

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

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

12/51699-1

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CAAE: 08223513.3.0000.0068

Identifier Type: -

Identifier Source: org_study_id