Neurocognitive DeficitNCT07846839
Validation of MoCA-B and MoCA-Blind for Screening Cognitive Decline
An observational study of Neurocognitive Deficit, run by Universidade Federal do Rio Grande do Norte.
Trial summary
The objective of this observational study is to assess the efficacy of two neuropsychological tests (MoCA-B and MoCA-Blind) in detecting cognitive decline in older adults. The main questions it aims to answer are: Can the results obtained by older adults on the MoCA-B distinguish between those with and without… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Neurocognitive Deficit
- How many people
- 124 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Mar 2027
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Older adults (60 years or older) with and without cognitive decline and with and without visual impairment.
Who may be able to join
- Older adults aged 60 and over;
Who cannot join
- Participants under 60 years of age
- Participants with a prior neuropsychological, neurological, or psychiatric diagnosis that could negatively influence assessment results, such as schizophrenia, stroke within the last three months, intellectual disability, etc
- Participants with self-reported or diagnosed hearing impairment (hearing loss or deafness) that is not corrected by hearing aids.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Validation of the Brazilian Version of the Montreal Cognitive Assessment - Basic (MoCA-B) and Montreal Cognitive Assessment - Blind (MoCA-Blind) for Screening Cognitive Decline
The objective of this observational study is to assess the efficacy of two neuropsychological tests (MoCA-B and MoCA-Blind) in detecting cognitive decline in older adults. The main questions it aims to answer are:
Can the results obtained by older adults on the MoCA-B distinguish between those with and without cognitive decline? Can the results obtained by older adults on the MoCA-Blind distinguish between those with and without cognitive decline?
Participants will be required to: 1. Complete a sociodemographic questionnaire; 2. Undergo a visual acuity test; 3. Complete the Pfeffer and IQCODE scales; and 4. Complete the MMSE, MoCA-B, and MoCA-Blind.
- Conditions
- Neurocognitive Deficit
- Keywords
- neurocognitive déficit, MoCA-B, MoCA-Blind, neuropsychological assessment, visual impairment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| older adults with cognitive decline and without visual impairment | Not described | |
| older adults without cognitive decline (healthy) and without visual impairment | Not described | |
| older adults with cognitive decline and with visual impairment | Not described | |
| older adults without cognitive decline and with visual impairment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Optimal cut-off score for the MoCA-B and MoCA-Blind
The scores obtained by the participants (0 to 30) will be used to calculate the ROC curve and determine the optimal cutoff point (highest sensitivity and specificity) to distinguish between cognitive decline and healthy individuals.
Measured: Assessed at baseline (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DeficitStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Collaborators
- Federal University of São Paulo, Universidade Federal de Goias, Universidade Estadual de Goiás, Universidade Federal do Rio Grande (FURG)
- Responsible party
- Principal investigator, Letícia Ellen Cunha Pereira, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07846839
- Sponsor's protocol ID
- 01815126.6.1001.5537
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the Brazilian Version of the Montreal Cognitive Assessment - Basic (MoCA-B) and Montreal Cognitive Assessment - Blind (MoCA-Blind) for Screening Cognitive Decline
- ClinicalTrials.gov ID
- NCT07846839
- Acronym / sponsor ID
- 01815126.6.1001.5537
- Conditions
- Neurocognitive Deficit
- Keywords
- neurocognitive déficit, MoCA-B, MoCA-Blind, neuropsychological assessment, visual impairment
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Collaborators
- Federal University of São Paulo, Universidade Federal de Goias, Universidade Estadual de Goiás, Universidade Federal do Rio Grande (FURG)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 29 Sep 2026 (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 objective of this observational study is to assess the efficacy of two neuropsychological tests (MoCA-B and MoCA-Blind) in detecting cognitive decline in older adults. The main questions it aims to answer are:
Can the results obtained by older adults on the MoCA-B distinguish between those with and without cognitive decline? Can the results obtained by older adults on the MoCA-Blind distinguish between those with and without cognitive decline?
Participants will be required to: 1. Complete a sociodemographic questionnaire; 2. Undergo a visual acuity test; 3. Complete the Pfeffer and IQCODE scales; and 4. Complete the MMSE, MoCA-B, and MoCA-Blind.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| older adults with cognitive decline and without visual impairment | – | – |
| older adults without cognitive decline (healthy) and without visual impairment | – | – |
| older adults with cognitive decline and with visual impairment | – | – |
| older adults without cognitive decline and with visual impairment | – | – |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Older adults (60 years or older) with and without cognitive decline and with and without visual impairment.
Key inclusion criteria (1 listed)
- Older adults aged 60 and over;
Key exclusion criteria (3 listed)
- Participants under 60 years of age
- Participants with a prior neuropsychological, neurological, or psychiatric diagnosis that could negatively influence assessment results, such as schizophrenia, stroke within the last three months, intellectual disability, etc
- Participants with self-reported or diagnosed hearing impairment (hearing loss or deafness) that is not corrected by hearing aids.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Optimal cut-off score for the MoCA-B and MoCA-Blind
Time frame: Assessed at baseline (Day 0)
The scores obtained by the participants (0 to 30) will be used to calculate the ROC curve and determine the optimal cutoff point (highest sensitivity and specificity) to distinguish between cognitive decline and healthy individuals.
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 29 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Deficit, run by Universidade Federal do Rio Grande do Norte.
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 3 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: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Letícia C Pereira, Master's Student (+55 (84) 999104200, leticiaellencp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Optimal cut-off score for the MoCA-B and MoCA-Blind (time frame: Assessed at baseline (Day 0)). 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 29 Sep 2026.