Mild Cognitive ImpairmentNCT02205710
Adaptive Cognitive Training in Healthy Older Adults
A study testing Computerized cognitive training and Computerized games in people with Mild Cognitive Impairment and Mild to Moderate Dementia, run by Bruyère Health Research Institute. at 1 site in Canada.
Trial summary
Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate cognitive function in older adults and individuals with dementia. In recent years, such training has become particularly appealing in the clinical context, with many paradigms aimed specifically at adults experiencing various… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, Mild to Moderate Dementia, Alzheimer's Disease
- What is being tested?
- Computerized cognitive training and Computerized games
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 99 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2016to Aug 2018
- 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
- English as the maternal or primary spoken language.
- Good self-reported health (i.e., no cerebro-, or cardio-vascular disease or neurological disease).
- Normal or corrected-to-normal vision and hearing.
Who cannot join
- Poor hearing or vision
- Inadequate understanding of the English language
Trial locations and contacts
1 site in 1 country.
About this study
Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate cognitive function in older adults and individuals with dementia. In recent years, such training has become particularly appealing in the clinical context, with many paradigms aimed specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For example, uncertainty persists regarding factors that influence observed improvements as well as the conditions that would maximize transfer and sustainability of training effects. The objective of this study is to evaluate factors that may maximize the benefits of computerized cognitive training in older adults.
Read the detailed description
The study involves 25 sessions of an adaptive cognitive training program, completed over 5 weeks. Pre and post training assessments will evaluate any near and far transfer effects of training.
- Being tested
- Computerized cognitive training, Computerized games
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized cognitive trainingOther
Also called Activate
Computerized gamesOther
| Study group | Role | What they receive |
|---|---|---|
| Computerized cognitive training | Experimental | Series of gamified tasks. Receives: Other: Computerized cognitive training |
| Computerized game training | Placebo comparator | Series of gamified tasks. Receives: Other: Computerized games |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in ratings on cognitive training survey
This survey aims to assess participant perceptions on cognitive training, and includes a series of related questions, rated on a scale of 1-7.
Measured: Baseline, week 5
Change in neural activity
We will measure resting state as well as task-related EEG responses to determine the effects of cognitive training at the neural level.
Measured: Baseline, week 5
Change in performance on neuropsychological tests
Using a set of standard neuropsychological evaluations, we will measure changes in attention, memory, and executive function following cognitive training.
Measured: Baseline, week 5
Secondary outcomes (1)
Change in ratings of psychological wellbeing
We will use standardized questionnaires to assess quality of life, in order to measure the influence of cognitive training on factors related to wellbeing.
Measured: Baseline, week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2014 (estimated)
- Study startAug 2016
- Primary completionAug 2018
- Study completionAug 2018
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bruyère Health Research Institute.
- Sponsor type
- University, hospital or other
- Collaborators
- University of Ottawa
- Responsible party
- Sponsor
- Investigators
- Patrick Davidson, PhD, Principal investigator, University of OttawaSheida Rabipour, MSc, Study director, University of Ottawa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02205710
- Sponsor's protocol ID
- M16-14-018
- Status last verified
- Aug 2017
- First submitted
- 29 Jul 2014
- Last updated
- 2 Aug 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adaptive Cognitive Training in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT02205710
- Acronym / sponsor ID
- M16-14-018
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Bruyère Health Research Institute.University, hospital or other
- Collaborators
- University of Ottawa
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 31 Jul 2014 (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.
Cognitive training has emerged as a promising method to maintain, enhance, and rehabilitate cognitive function in older adults and individuals with dementia. In recent years, such training has become particularly appealing in the clinical context, with many paradigms aimed specifically at adults experiencing various stages of cognitive decline due to Mild Cognitive Impairment, Alzheimer's disease, and vascular dementias. However, basic questions remain. For example, uncertainty persists regarding factors that influence observed improvements as well as the conditions that would maximize transfer and sustainability of training effects. The objective of this study is to evaluate factors that may maximize the benefits of computerized cognitive training in older adults.
Detailed description
The study involves 25 sessions of an adaptive cognitive training program, completed over 5 weeks. Pre and post training assessments will evaluate any near and far transfer effects of training.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Computerized cognitive training | Experimental | Other: Computerized cognitive trainingSeries of gamified tasks. |
| Computerized game training | Placebo comparator | Other: Computerized gamesSeries of gamified tasks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- English as the maternal or primary spoken language.
- Good self-reported health (i.e., no cerebro-, or cardio-vascular disease or neurological disease).
- Normal or corrected-to-normal vision and hearing.
Key exclusion criteria (2 listed)
- Poor hearing or vision
- Inadequate understanding of the English language
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: Activate | Other | Computerized cognitive training |
| Computerized games | Other | Computerized game training |
Primary outcome
Change in ratings on cognitive training survey
Time frame: Baseline, week 5
This survey aims to assess participant perceptions on cognitive training, and includes a series of related questions, rated on a scale of 1-7.
Change in neural activity
Time frame: Baseline, week 5
We will measure resting state as well as task-related EEG responses to determine the effects of cognitive training at the neural level.
Change in performance on neuropsychological tests
Time frame: Baseline, week 5
Using a set of standard neuropsychological evaluations, we will measure changes in attention, memory, and executive function following cognitive training.
1 secondary outcome
Change in ratings of psychological wellbeing
Time frame: Baseline, week 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2019.
- Dr. Patrick DavisonLink provided by the sponsor.
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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.
Patrick Davidson, PhD principal investigator
University of Ottawa
Sheida Rabipour, MSc study director
University of Ottawa
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 Computerized games in people with Mild Cognitive Impairment and Mild to Moderate Dementia, run by Bruyère Health Research Institute. at 1 site in Canada.
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: finished, as of the sponsor's last update on 2 Aug 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 Canada. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in ratings on cognitive training survey (time frame: Baseline, week 5). The study lists 3 primary outcomes in all. 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 2 Aug 2019.