Clinical trial NCT03263247: Cognitive Training in Patients With MCI Using fMRI
Official title: Randomized Double Blind Study on the Efficacy of Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Mild Cognitive Impairment
Lead sponsor: São Paulo State University
Sponsor class: OTHER
Collaborators: name: Ricardo Nitrini
name: Sonia Brucki
name: Maira Okada de Oliveira
name: Edson Amaro Junior
name: Maria da Graca M Martin
name: Rodolfo dos Anjos
name: Camila Carneiro Pedroza
name: Ana Carolina Cruz
name: Aline Gisele Gonçalves
name: Leticia Nery Celino de Souza Pak
name: Letícia Ferreira da Mota
name: Paulo Rodrigo Bazán
name: Isabella Maria Bello Avolio
First posted: 2017-08-28
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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).

Detailed description: 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).

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 functional magnetic resonance imaging (fMRI)
timeFrame: Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance
measure: Changes in memory and language measures
timeFrame: Baseline and after 4 weeks of intervention - generalization
Secondary outcomes:
measure: Changes in perception of memory performance
timeFrame: Baseline, within four weeks after intervention
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of Sao Paulo
state: Sao Paulo
Study officials:
References: