AgingNCT02632604
Computerized Cognitive Training for the Elderly
A study testing Computerized cognitive training and Computer games in people with 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 a neuroplasticity-based computerized cognitive training for the elderly Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Computerized cognitive training and Computer games
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2014to Dec 2019
- Phase
- Interventional
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;
Who cannot join
- Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Federal University of Rio de Janeiro
Rio de Janeiro, Rio de Janeiro, 21941590
Linda Scoriels, Ph.D., +552139385588, lindascor@yahoo.fr
About this study
The purpose of this study is to investigate the effect of a neuroplasticity-based computerized cognitive training for the elderly
Read the detailed description
Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.
The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.
The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.
The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.
- Conditions
- Aging
- Being tested
- Computerized cognitive training, Computer games
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingBehavioural
Also called cognitive training, training
40 hours of a computerized cognitive training, given 1 hour daily
Computer gamesBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Bottom-up to top-down cognitive training | Active comparator | Participants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes Receives: Behavioral: Computerized cognitive training |
| Top-down to bottom-up cognitive training | Active comparator | Participants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes Receives: Behavioral: Computerized cognitive training |
| Computer games | Placebo comparator | Participants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc). Receives: Behavioral: Computer games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global cognition score change
An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline
Measured: through study completion, an average of 1 year
Secondary outcomes (19)
Processing speed score change
Processing speed score will be measured using the identification task from Cogstate tests battery
Measured: through study completion, an average of 1 year
Attention score change
Attention score will be measured using the detection task from Cogstate tests battery
Measured: through study completion, an average of 1 year
Concentration score change
Concentration score will be measured using the Trail Making Test
Measured: through study completion, an average of 1 year
Short-term memory score change
Short- term memory score will be measured using the Rey Auditory-Verbal learning test
Measured: through study completion, an average of 1 year
long-term memory score change
long- term memory score will be measured using the Rey Auditory-Verbal learning test
Measured: through study completion, an average of 1 year
learning score change
learning score will be measured using the Rey Auditory-Verbal learning test
Measured: through study completion, an average of 1 year
working memory score change
working memory score will be measured using the 1-back and 2-back tasks from the Cogstate tests battery
Measured: through study completion, an average of 1 year
Semantic memory score change
semantic memory score will be measured using the Verbal fluency test
Measured: through study completion, an average of 1 year
Cognitive flexibility score change
Cognitive flexibility score will be measured using the Set shifting task from the Cogstate tests battery
Measured: through study completion, an average of 1 year
social cognition score change
Social cognition score will be measured using the Social-Emotional Cognition task from the Cogstate tests battery
Measured: through study completion, an average of 1 year
Depression score change
Depression score will be measured using the Geriatric Depression Scale
Measured: through study completion, an average of 1 year
Instrumental activity of daily living score change
Instrumental activity of daily living score will be measured using the Lawton instrumental activity of daily living scale
Measured: through study completion, an average of 1 year
Independence in activities of daily living score change
Independence in activities of daily living score will be measured using the Katz Independence in activities of daily living scale
Measured: through study completion, an average of 1 year
Functional status score change
Functional status score will be measured using the Direct Assessment of Functional Status questionnaire
Measured: through study completion, an average of 1 year
Timed instrumental activities of daily living score change
Timed instrumental activities of daily living score will be measured using the Timed instrumental activities of daily living scale
Measured: through study completion, an average of 1 year
Physical activity score change
Physical activity score will be measured using the International Physical Activity Questionnaire
Measured: through study completion, an average of 1 year
Praxis score change
Praxis score will be measured using the Cambridge Cognition Examination test
Measured: through study completion, an average of 1 year
Episodic memory score change
Episodic memory score will be measured using the Cambridge Cognition Examination test
Measured: through study completion, an average of 1 year
Quality of life score change
Quality of life will be assessed with the World Health Organization Quality of Life questionnaire
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2015 (estimated)
- Study startJan 2014
- Primary completionDec 2018 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 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
- Investigators
- Rogério Panizzutti, M.D, PhD, Principal investigator, Universidade Federal do Rio de Janeiro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02632604
- Sponsor's protocol ID
- 110.180/2013
- Status last verified
- Jan 2018
- First submitted
- 14 Dec 2015
- Last updated
- 17 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computerized Cognitive Training for the Elderly
- ClinicalTrials.gov ID
- NCT02632604
- Acronym / sponsor ID
- 110.180/2013
- Conditions
- Aging
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio de JaneiroUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 16 Dec 2015 (estimated)
- 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 a neuroplasticity-based computerized cognitive training for the elderly
Detailed description
Cognitive impairments are prominent features of aging and are mostly characterized by memory difficulties. Neuroplasticity based computerized cognitive trainings have been emerging for the last two decades and are an attempt to help the elderly population with their impairments.
The aim of this study is to perform a computerized cognitive training to improve attention, concentration, learning, and quality of life in elderly participants. The investigators are interested in testing the differential efficacy between a bottom-up to top-down versus a top-down to bottom-up computerized cognitive training.
The investigators will conduct a 40 hours computerized, adaptable, cognitive training program in participants 60 years of age and above. Participants will come for 1 hour, daily, and perform a bottom-up to top-down or top-down to bottom-up training, or control games for about 2 months. Bottom-up to top-down and top-down to bottom-up exercises are chosen to target cognitive domains such as divided and selective attention, short-term and working memory, orientation skills and social cognition. Cognitive and emotional data will be collected before the training, half way through, and after the training, to assess progress in several aspects of their functioning.
The investigators hypothesize bottom-up to top-down and top-down to bottom-up trainings will be effective as compared to the control games. They also expect that bottom-up to top-down training to be more efficient compared to top-down to bottom-up training because the first targets more basic cognitive functions which then allows triggering higher cognitive functions, reaching optimal cognitive performance levels more rapidly, where as the second may start with a too high demand on cognitive functions, which may compromise participants ability to reach optimal levels of cognitive performance as fast as the first type of training, if they do not have the "bottom-up lever" first. The investigators also hypothesize that both trainings will improve quality of life.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bottom-up to top-down cognitive training | Active comparator | Behavioral: Computerized cognitive trainingParticipants are given 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes |
| Top-down to bottom-up cognitive training | Active comparator | Behavioral: Computerized cognitive trainingParticipants are given 20 hours of cognitive training with exercises that involve essentially top-down cognitive processes, followed by 20 hours of cognitive training with exercises that involve essentially bottom-up cognitive processes |
| Computer games | Placebo comparator | Behavioral: Computer gamesParticipants are given 40 hours of computer games commonly found on the internet and which do not involve a high demand in cognitive functions (e.g. fishing game, pinball game, tetris, etc). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age above 60 years old; Portuguese as main language (learned before 12 years of age); Mini Mental State Examination above 26 points;
Key exclusion criteria (1 listed)
- Intellectual Quotient below 70; serious medical or neurological condition preventing from participation in the study; substance abuse (according to Diagnostic and Statistical Manual of mental disorders-IV criteria).
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 |
|---|---|---|
| Computerized cognitive trainingAlso: cognitive training, training40 hours of a computerized cognitive training, given 1 hour daily | Behavioural | Bottom-up to top-down cognitive training, Top-down to bottom-up cognitive training |
| Computer games | Behavioural | Computer games |
Primary outcome
Global cognition score change
Time frame: through study completion, an average of 1 year
An average of all the cognitive measures will be done to calculate the global cognition score and change will be made between endpoint and midpoint and midpoint and baseline
19 secondary outcomes
Processing speed score change
Time frame: through study completion, an average of 1 year
Attention score change
Time frame: through study completion, an average of 1 year
Concentration score change
Time frame: through study completion, an average of 1 year
Short-term memory score change
Time frame: through study completion, an average of 1 year
long-term memory score change
Time frame: through study completion, an average of 1 year
learning score change
Time frame: through study completion, an average of 1 year
working memory score change
Time frame: through study completion, an average of 1 year
Semantic memory score change
Time frame: through study completion, an average of 1 year
Cognitive flexibility score change
Time frame: through study completion, an average of 1 year
social cognition score change
Time frame: through study completion, an average of 1 year
Depression score change
Time frame: through study completion, an average of 1 year
Instrumental activity of daily living score change
Time frame: through study completion, an average of 1 year
Independence in activities of daily living score change
Time frame: through study completion, an average of 1 year
Functional status score change
Time frame: through study completion, an average of 1 year
Timed instrumental activities of daily living score change
Time frame: through study completion, an average of 1 year
Physical activity score change
Time frame: through study completion, an average of 1 year
Praxis score change
Time frame: through study completion, an average of 1 year
Episodic memory score change
Time frame: through study completion, an average of 1 year
Quality of life score change
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
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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.
Rogério Panizzutti, M.D, PhD principal investigator
Universidade Federal do Rio de Janeiro
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized cognitive training and Computer games in people with 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 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: status not confirmed, as of the sponsor's last update on 17 Jan 2018. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rogério Panizzutti, M.D, PhD (+552139386390, rogerio@icb.ufrj.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global cognition score change (time frame: through study completion, an average of 1 year). 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 17 Jan 2018.