Cognitive Training in Patients With MCI Using fMRI

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03263247
• Other study ID #: MCI cognitive training
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2, 2017
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: São Paulo State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Behavioral:
• Memory Training

• Psychoeducation

• Alphabet search

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	São Paulo	Sao Paulo

Sponsors (14)

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

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in functional magnetic resonance imaging (fMRI)	fMRI correlates of behavioral performance	Baseline and after 4 weeks of intervention fMRI correlates of behavioral performance
Primary	Changes in memory and language measures	Improvement in Logical Memory Test I and II results and naming tests	Baseline and after 4 weeks of intervention - generalization
Secondary	Changes in perception of memory performance	Multifactorial Memory Questionnaire	Baseline, within four weeks after intervention