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NCT Number: NCT03263247

Cognitive Training in Patients With MCI Using fMRI

The current project aims to investigate the efficacy of the visual imaging training (VIT) and alphabet search training in comparison to an active control intervention, namely psychoeducation information (PI) using fMRI in patients with amnestic mild cognitive impairment (MCI) and healthy elderly controls (HE). MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

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This study is active but is not currently recruiting participants.

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Key information

Age range

60 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Sao Paulo

São Paulo, 05403000, Brazil

About this study

We will include 30 subjects with amnestic mild cognitive impairment (MCI) single domain or multiple domain clinical diagnostic, over 60 years old, recruited through the Cognitive and Behavioral Neurology Group ambulatory of University of Sao Paulo General Hospital. We will also include 30 healthy subjects, over 60 years old, recruited in the community. All the participants will be evaluated by neurologists specialized in cognitive neurology and subjected to a neuropsychological assessment. The 30 participants with MCI and 30 healthy subjects will be divided in 6 groups: the G1 MCI group (N=10) will receive 4 sessions of visual imaging training; the G2 control group (N=10) will receive 4 sessions of visual imaging training; the G3 MCI group (N=10) will receive psychoeducation intervention; the G4 control group (N=20) will receive psychoeducation intervention; the G5 MCI group (N=10) will receive cognitive training with alphabet search training and the G6 control group will receive cognitive training with alphabet search training. This will be a longitudinal, randomized, double blind study. MCI patients will be grouped according to biomarkers (PET PIB, PET FDG and liquor).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

memory training

Behavioral

Psychoeducation

Behavioral

Alphabet search

Behavioral

Primary outcomes

  1. Changes in functional magnetic resonance imaging (fMRI)

    Time frame: Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance

    fMRI correlates of behavioral performance

  2. Changes in memory and language measures

    Time frame: Baseline and after 4 weeks of intervention - generalization

    Improvement in Logical Memory Test I and II results and naming tests

Secondary outcomes

  1. Changes in perception of memory performance

    Time frame: Baseline, within four weeks after intervention

    Multifactorial Memory Questionnaire

Sponsors and collaborators

Lead sponsor

São Paulo State University

Other

Collaborators

  • Aline Gisele Gonçalves
  • Ana Carolina Cruz
  • Camila Carneiro Pedroza
  • Edson Amaro Junior
  • Isabella Maria Bello Avolio
  • Leticia Nery Celino de Souza Pak
  • Letícia Ferreira da Mota
  • Maira Okada de Oliveira
  • Maria da Graca M Martin
  • Paulo Rodrigo Bazán
  • Ricardo Nitrini
  • Rodolfo dos Anjos
  • Sonia Brucki

Registry information

Official study title

Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.

Important dates

Study start
2017
Primary completion
2026
Study completion
2026
First posted
Aug 28, 2017
Registry last updated
Jul 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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