Mild Cognitive ImpairmentPhase 1NCT03911765
Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
A Phase 1 study testing digital cognitive training in people with Mild Cognitive Impairment and Aging, run by Universidade Federal do Rio de Janeiro at 1 site in Brazil.
Trial summary
The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Aging
- What is being tested?
- digital cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 2 Jan 2019to 2 Dec 2019
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age above 65 years old;
- Elderly enrolled in home for aged in wich the research is taking place;
- Montreal Cognitive Assessment above 21 points;
Who cannot join
- Clinical diagnosis of Alzheimer's Disease;
- Serious medical or neurological condition preventing from participation in the study;
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Universidade Federal do Rio de Janeiro
Rio de Janeiro, Rio de Janeiro
Rogério Panizzutti, MD, Phd, 5521999090498, rogerio@icb.ufrj.br
Aline D'Avila, MSc, 5531987778981, lininha_davila@yahoo.com.br
About this study
The purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.
Read the detailed description
Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.
After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.
- Conditions
- Mild Cognitive Impairment, Aging
- Being tested
- digital cognitive training
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital cognitive trainingBehavioural
Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform.
| Study group | Role | What they receive |
|---|---|---|
| Executive Function cognitive training | Experimental | 20 hours of digital cognitive training targeting executive function. Receives: Behavioral: digital cognitive training |
| Games | Active comparator | 10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function. Receives: Behavioral: digital cognitive training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Performance in everyday living score change
Performance in everyday living score change will be measured using Canadian Occupational Performance Measure (COPM).
The Canadian Occupational Performance Measure (COPM) has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale.
Measured: 3 months
Secondary outcomes (1)
Functional status score change
Functional status score will be measured using the Direct Assessment of Functional Status-Revised (DAFS-R). DAFS-R assesses seven different domains of functional abilities by requiring the participant to carry out different tasks, two domains will be evaluated: dealing with Finances (score range 0-32) and shopping skills (score range 0-20), with higher scores indicating better functioning.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start2 Jan 2019
- Primary completion1 Jul 2019 (estimated)
- Study completion2 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Stepped wedge
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio de Janeiro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rogerio Panizzutti, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911765
- Sponsor's protocol ID
- 17976113.1.0000.5257
- Status last verified
- Apr 2019
- First submitted
- 9 Apr 2019
- Last updated
- 17 Apr 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Poltronieri BC, Carvalho CM, Reuwsaat K, Reis MEA, Madeira AC, de Carvalho Freire T, Panizzutti R. Does Dosage Drive Durability? A Longitudinal Study on Digital Cognitive Training for Sustained Functional Independence. Geriatr Gerontol Int. 2026 Oct;26(10):e70848. doi: 10.1111/ggi.70848.
PubMed 42791030Carvalho CM, Poltronieri BC, Reuwsaat K, Reis MEA, Panizzutti R. Digital cognitive training for functionality in mild cognitive impairment: a randomized controlled clinical trial. Geroscience. 2025 Jun;47(3):5111-5121. doi: 10.1007/s11357-024-01464-x. Epub 2025 Jan 6.
PubMed 39760921
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Digital Cognitive Training on the Functionality of Older Adults With Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT03911765
- Acronym / sponsor ID
- 17976113.1.0000.5257
- Conditions
- Mild Cognitive Impairment, Aging
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 1 Jul 2019 (estimated)
- Study completion
- 2 Dec 2019 (estimated)
- First posted
- 11 Apr 2019 (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 purpose of this study is to investigate the effect of digital cognitive training in the functionality of older adults with Mild Cognitive Impairment.
Detailed description
Mild Cognitive Impairment (MCI) is characterized by decline in one or more cognitive domains, including memory, attention, executive functions, language and visuospatial abilities, and in a significant portion of cases may evolve to Alzheimer's Disease. According to established diagnostic criteria, independence for daily life activities is preserved, but activities are carried out less effectiveness and efficiency, affected subjects usually take more time and make more mistakes, when compared to their pre-morbid performance. Different studies have observed that impairments in functional performance in older adults with MCI are associated with impairments in executive function. This study intends to verify the impact of the use of digital cognitive training for executive function on the functionality of older adults with MCI. Digital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. The active control group will play computer games available online. Both groups will play for 1 hour at least 2 times per week.
After baseline assessments, older adults with MCI will be stratified by age, education, gender, functional measurement and cognitive assessment, and randomly assigned to the intervention group with digital cognitive exercises or to the control group with computer games, in a stepped wedge design. Subjects will be evaluated at baseline and after completing 10 and 20 hours of intervention. After the first 10 hours of intervention both groups will be assigned to the intervention with digital cognitive exercises for additional 10 hours. Both groups will be comparable in terms of personal contact with staff and computer time. Our hypothesis is that the training using digital cognitive exercises will improve the executive function and that this gain has a positive impact on the functionality and accomplishment of the daily life activities of older adults with MCI.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Stepped wedge
| Arm | Type | Receives |
|---|---|---|
| Executive Function cognitive training | Experimental | Behavioral: digital cognitive training20 hours of digital cognitive training targeting executive function. |
| Games | Active comparator | Behavioral: digital cognitive training10 hours of computer games c available online which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc), followed by 10 hours of of digital cognitive training targeting executive function. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age above 65 years old;
- Elderly enrolled in home for aged in wich the research is taking place;
- Montreal Cognitive Assessment above 21 points;
Key exclusion criteria (2 listed)
- Clinical diagnosis of Alzheimer's Disease;
- Serious medical or neurological condition preventing from participation in 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 |
|---|---|---|
| digital cognitive trainingDigital cognitive exercises, used in the intervention group, have the primary objective of stimulating executive functions, and will be made available through the Internet using the BrainHQ platform. | Behavioural | Executive Function cognitive training, Games |
Primary outcome
Performance in everyday living score change
Time frame: 3 months
Performance in everyday living score change will be measured using Canadian Occupational Performance Measure (COPM). The Canadian Occupational Performance Measure (COPM) has a client-centered design and measures outcomes according to three occupational performance areas (self-care, productivity, and leisure), examining self-perceived changes in the occupational performance of patients through a semistructured interview. At the beginning, patients start by identifying their difficulties according to the three occupational performance areas. They subsequently use a 10-point scale, ranging from not at all crucial (1) to extremely crucial (10), to identify the intensity of certain difficulties. For the top five problems or tasks selected by patients, the interviewer asks them to continue identifying their performance and satisfaction with their performance by using the same 10-point rating scale.
1 secondary outcome
Functional status score change
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- Derived from this study: PubMed 42791030Poltronieri BC, Carvalho CM, Reuwsaat K, Reis MEA, Madeira AC, de Carvalho Freire T, Panizzutti R. Does Dosage Drive Durability? A Longitudinal Study on Digital Cognitive Training for Sustained Functional Independence. Geriatr Gerontol Int. 2026 Oct;26(10):e70848. doi: 10.1111/ggi.70848.
- Derived from this study: PubMed 39760921Carvalho CM, Poltronieri BC, Reuwsaat K, Reis MEA, Panizzutti R. Digital cognitive training for functionality in mild cognitive impairment: a randomized controlled clinical trial. Geroscience. 2025 Jun;47(3):5111-5121. doi: 10.1007/s11357-024-01464-x. Epub 2025 Jan 6.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing digital cognitive training in people with Mild Cognitive Impairment and Aging, run by Universidade Federal do Rio de Janeiro 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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Apr 2019. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogério Panizzutti (21999090498 ext. 55, rpanizzutti@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Performance in everyday living score change (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911765, which also lists 2 linked publications.
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 17 Apr 2019; AzTrials last refreshed its copy on 6 Nov 2026.