NCT01978353

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2012

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

November 7, 2013

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
Last Updated

October 26, 2015

Status Verified

October 1, 2015

Enrollment Period

2.9 years

First QC Date

October 21, 2013

Last Update Submit

October 23, 2015

Conditions

Mild Cognitive Impairment

Keywords

Mild cognitive impairmentDementiaAlzheimer's diseaseMemory TrainingCognitive TrainingCognitive RehabilitationNeuropsychological Rehabilitation

Outcome Measures

Primary Outcomes (2)

  • 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

  • Changes in functional magnetic resonance imaging (fMRI)

    fMRI correlates of behavioral performance at face-name task

    Baseline and within two weeks after intervention

Secondary Outcomes (2)

  • Changes in perception of memory performance and mood

    Baseline, within two weeks after intervention

  • Changes in memory performance and perception of memory performance over time - follow up

    One and three months after intervention

Study Arms (2)

Memory Training

EXPERIMENTAL

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

Behavioral: Memory Training

Psychoeducation

ACTIVE COMPARATOR

Participants receive information about memory functioning and aging

Behavioral: Psychoeducation

Interventions

Memory TrainingBEHAVIORAL

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

Memory Training
PsychoeducationBEHAVIORAL

Participants receive information about memory functioning and aging

Psychoeducation

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer Disease

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

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

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

    STUDY DIRECTOR

  • Sharon Sanz Simon, Ph.D Student

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 21, 2013

First Posted

November 7, 2013

Study Start

November 1, 2012

Primary Completion

October 1, 2015

Study Completion

October 1, 2015

Last Updated

October 26, 2015

Record last verified: 2015-10

Locations

BR(1)