Mild Cognitive ImpairmentNCT03263247
Cognitive Training in Patients With MCI Using fMRI
A study testing Visual Memory Training and Alphabet search in people with Mild Cognitive Impairment, run by São Paulo State University at 1 site in Brazil.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 60 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Visual Memory Training and Alphabet search
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2017to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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);
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Mild Cognitive Impairment
- Being tested
- Visual Memory Training, Alphabet search
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Memory TrainingBehavioural
In the first phase of the study all participants will receive visual memory training. In the second phase they will receive alphabetic search training
Alphabet searchBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Visual Imaging Training | Experimental | Participants will receive visual imaging training to facilitate learning of written information.
Intervention: Visual Imaging Training in individual sessions Receives: Behavioral: Visual Memory Training; Behavioral: Alphabet search |
What is being measured
The primary outcome is the main question the study is designed to answer.
Results from task performance in functional magnetic resonance imaging (fMRI)
fMRI behavioral performance
Measured: Baseline, after CT, and 12 months later
Secondary outcomes (1)
Changes in cognitive measures and brain activation
Logical Memory Test I and II, RAVLT I e II, brain activity, generalization tasks
Measured: Baseline, after CT e 12 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2017
- Study start2 Jan 2017
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- São Paulo State University
- Sponsor type
- University, hospital or other
- Collaborators
- Ricardo Nitrini, Sonia Brucki, Maira Okada de Oliveira, Edson Amaro Junior, Maria da Graca M Martin, Rodolfo dos Anjos, Camila Carneiro Pedroza, Ana Carolina Cruz, Aline Gisele Gonçalves, Leticia Nery Celino de Souza Pak, Letícia Ferreira da Mota, Paulo Rodrigo Bazán, Isabella Maria Bello Avolio
- Responsible party
- Principal investigator, Eliane Mioto, São Paulo State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03263247
- Sponsor's protocol ID
- MCI cognitive training
- Status last verified
- Aug 2026
- First submitted
- 24 Aug 2017
- Last updated
- 24 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Training in Patients With Mild Cognitive Impairment Using fMRI.
- ClinicalTrials.gov ID
- NCT03263247
- Acronym / sponsor ID
- MCI cognitive training
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- São Paulo State UniversityUniversity, hospital or other
- Collaborators
- Ricardo Nitrini, Sonia Brucki, Maira Okada de Oliveira, Edson Amaro Junior, Maria da Graca M Martin, Rodolfo dos Anjos, Camila Carneiro Pedroza, Ana Carolina Cruz, Aline Gisele Gonçalves, Leticia Nery Celino de Souza Pak, Letícia Ferreira da Mota, Paulo Rodrigo Bazán, Isabella Maria Bello Avolio
- Study start
- 2 Jan 2017 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Visual Imaging Training | Experimental | Behavioral: Visual Memory Training, Behavioral: Alphabet searchParticipants will receive visual imaging training to facilitate learning of written information. Intervention: Visual Imaging Training in individual sessions |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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);
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Memory TrainingIn the first phase of the study all participants will receive visual memory training. In the second phase they will receive alphabetic search training | Behavioural | Visual Imaging Training |
| Alphabet search | Behavioural | Visual Imaging Training |
Primary outcome
Results from task performance in functional magnetic resonance imaging (fMRI)
Time frame: Baseline, after CT, and 12 months later
fMRI behavioral performance
1 secondary outcome
Changes in cognitive measures and brain activation
Time frame: Baseline, after CT e 12 months follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visual Memory Training and Alphabet search in people with Mild Cognitive Impairment, run by São Paulo State University at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Results from task performance in functional magnetic resonance imaging (fMRI) (time frame: Baseline, after CT, and 12 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2026; AzTrials last refreshed its copy on 28 Oct 2026.