Clinical trial NCT01978353: 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
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment
Keywords: Mild cognitive impairment
Dementia
Alzheimer's disease
Memory Training
Cognitive Training
Cognitive Rehabilitation
Neuropsychological Rehabilitation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2013-11-07
Enrollment: 30
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in memory measures
timeFrame: Baseline and within two weeks after intervention
measure: Changes in functional magnetic resonance imaging (fMRI)
timeFrame: Baseline and within two weeks after intervention
Secondary outcomes:
measure: Changes in perception of memory performance and mood
timeFrame: Baseline, within two weeks after intervention
measure: Changes in memory performance and perception of memory performance over time - follow up
timeFrame: One and three months after intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo, Faculty of Medicine, Institute and Department of Psychiatry
Study officials:
affiliation: Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
name: Cássio Machado de Campos Bottino, M.D., Ph.D
role: STUDY_DIRECTOR
affiliation: Old Age Research Group (PROTER), Institute and Department of Psychiatry, Faculty of Medicine
name: Sharon Sanz Simon, Ph.D Student
role: PRINCIPAL_INVESTIGATOR
References: