- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03263247
Cognitive Training in Patients With MCI Using fMRI
August 20, 2026 updated by: Eliane Mioto, São Paulo State University
Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.
The current project aims to investigate the trajectories of the visual imaging cognitive training (CT) and alphabet search training 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).
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Detailed Description
We will include 40 subjects with amnestic mild cognitive impairment (MCI) multiple domain clinical diagnostic, over 60 years old, recruited through the outpatient clinic of University of Sao Paulo General Hospital.
We will also include 20 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 40 participants with MCI and 20 healthy subjects will receive 6 sessions of visual imaging training.
After this first study, they will receive cognitive training with alphabet search training.
This will be a longitudinal study.
MCI patients will be grouped according to biomarkers (PET PIB).
Study Type
Interventional
Enrollment (Estimated)
60
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
São Paulo
-
São Paulo, São Paulo, Brazil, 05403000
- University of Sao Paulo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years to 90 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
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);
Exclusion Criteria:
- History of neurological disorder, 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Visual Imaging Training
Participants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions |
In the first phase of the study all participants will receive visual memory training.
In the second phase they will receive alphabetic search training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Results from task performance in functional magnetic resonance imaging (fMRI)
Time Frame: Baseline, after CT, and 12 months later
|
fMRI behavioral performance
|
Baseline, after CT, and 12 months later
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Changes in cognitive measures and brain activation
Time Frame: Baseline, after CT e 12 months follow-up
|
Logical Memory Test I and II, RAVLT I e II, brain activity, generalization tasks
|
Baseline, after CT e 12 months follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2017
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2026
Study Registration Dates
First Submitted
August 24, 2017
First Submitted That Met QC Criteria
August 24, 2017
First Posted (Actual)
August 28, 2017
Study Record Updates
Last Update Posted (Actual)
August 24, 2026
Last Update Submitted That Met QC Criteria
August 20, 2026
Last Verified
August 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MCI cognitive training
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.