Memory ProblemsNCT03600545
Brain Fitness APP for Aging With a Healthy Brain
A study testing Brain Fitness App in people with Memory Problems, run by University of Manitoba at 1 site in Canada.
Trial summary
Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Memory Problems
- What is being tested?
- Brain Fitness App
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteCanada
- Study dates
- 20 Jun 2018to 10 Apr 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- MoCA ≥ 25
- Have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, dementia of any type, or any other neurological degenerative disease.
- Capable of using an iPAD and access to Internet at home.
- Reading/writing fluency in English
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Brain Fitness APP for Aging With a Healthy Brain and Detecting Cognitive Declines
Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. While currently there is no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy life style. The proposed research offers a novel approach to prevent dementia and age-related cognitive disorders.
It is proposed to create a brain fitness APP for the aging population. The proposed APP is based on the premise of brain plasticity, and targets the brain functions that are declining with normal aging and dementia.
Read more
The proposed APP will be tested on a large population with statistical rigor (60 healthy individuals of age 65+ years and up to 30 individuals with cognitive impairment); the participants will be divided into an intervention group and a control group. We will analyze the logged performance of the participants, and assess their cognitive state with an independent test compared to a matched control group before and after the trial.
It is anticipated that the frequent use of the proposed APP will help to maintain a healthy brain as well as detecting the onset of a cognitive decline in aging population. In addition, its frequent use will slow and even reverse the progression of the cognition decline in individuals with mild cognitive impairment or dementia. The APP will have many different levels of difficulty so that it can be applied to a wide age range and conditions.
Read the detailed description
The research is on the frequent use of our designed APP (for iPADs) that contains a series of our recently developed brain exercises that contains a series of our recently developed brain exercises, including orientation, associative memory, word-image association, recall memory, etc.
Participants will be randomly assigned to either Intervention or Control Arm. Participants of Intervention Arm must have access to an iPAD at least for the duration of the study.
Procedure for Intervention Arm The participants in Intervention Arm will have a training session (after obtaining their consent form) for the Brain Exercises. The Brain Fitness App will be downloaded into their iPAD and they will be instructed on how to use it. As mentioned in their consent form, they will commit themselves to play the games on a daily basis for (at least 5 days/week), twice/day, each session of minimum 15 minutes for a period of 4 consecutive weeks.
Procedure for Control Arm Participants of this arm will do nothing but will be assessed at baseline, 4 week and 8 weeks later. Their data will be used as the control data for comparison with the Intervention Arm data. All participants of this group, if interested, will be offered to practice the Brain Fitness App if they wish after their completion of this study (2 months period).
- Conditions
- Memory Problems
- Being tested
- Brain Fitness App
- Medical subject headings
- Memory Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain Fitness AppOther
Brain exercises using an iPAD
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | 4 weeks daily practice of the brain exercises Receives: Other: Brain Fitness App |
| control | No intervention | no brain exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in Wechsler Memory Scale (WMS IV) from baseline
This assessment has a total of 11 tests, out of which we will use its six primary tests that assess our target brain functions, comprised of 12 subtests (subsections): Logical Memory 1, Verbal Paired Associates 1, Faces 1, Family Pictures 1, Logical Memory 2, Verbal Paired Associates 2, Faces 2, Family Pictures 2, Verbal Paired Associates 2 Recognition, Logical Memory 2 Recognition, Letter-Number Sequencing and Spatial Span. They are classified into 3 major memory indexes: Immediate Memory, General Memory and Working Memory. The WMS test is being purchased online from the following link; they do not provide a softcopy.
Measured: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Secondary outcomes (2)
Change in Egocentric Spatial Orientation
This test is one of the PI's designs that has been in use since a few years ago. It is used for detecting the onset of Alzheimer's. In this test participants sit in a customized wheelchair and by waking the wheelchair they move within a virtual cubic building to reach a particular target room. They can do this test either using the laptop screen or in its immersive version wearing a goggle (Oculus Rift 2).
Measured: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
The MADRS is a ten item rating scale for rating levels of depression. Each item is rated on a 7-point scale from 0 to 6, where 0 indicates absence of the symptom and 6 indicates extreme presence of the symptom. The time frame for the scale is the previous four weeks.
Measured: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2018
- Study start20 Jun 2018
- Primary completion10 Apr 2019
- Study completion10 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Memory ProblemsStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Collaborators
- Age-Well NCE Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03600545
- Sponsor's protocol ID
- B2018:029
- Status last verified
- Feb 2021
- First submitted
- 11 Apr 2018
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Fitness APP for Aging With a Healthy Brain and Detecting Cognitive Declines
- ClinicalTrials.gov ID
- NCT03600545
- Acronym / sponsor ID
- B2018:029
- Conditions
- Memory Problems
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Collaborators
- Age-Well NCE Inc.
- Study start
- 20 Jun 2018 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 10 Apr 2019 (actual)
- First posted
- 26 Jul 2018 (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.
Memory and cognitive declines are associated with normal brain aging but are also precursors to dementia, in particular the so called the pandemic of the century, Alzheimer's disease. While currently there is no cure or "vaccine" against dementia, there are hopes to delay the onset of the disease by living a brain-healthy life style. The proposed research offers a novel approach to prevent dementia and age-related cognitive disorders.
It is proposed to create a brain fitness APP for the aging population. The proposed APP is based on the premise of brain plasticity, and targets the brain functions that are declining with normal aging and dementia.
The proposed APP will be tested on a large population with statistical rigor (60 healthy individuals of age 65+ years and up to 30 individuals with cognitive impairment); the participants will be divided into an intervention group and a control group. We will analyze the logged performance of the participants, and assess their cognitive state with an independent test compared to a matched control group before and after the trial.
It is anticipated that the frequent use of the proposed APP will help to maintain a healthy brain as well as detecting the onset of a cognitive decline in aging population. In addition, its frequent use will slow and even reverse the progression of the cognition decline in individuals with mild cognitive impairment or dementia. The APP will have many different levels of difficulty so that it can be applied to a wide age range and conditions.
Detailed description
The research is on the frequent use of our designed APP (for iPADs) that contains a series of our recently developed brain exercises that contains a series of our recently developed brain exercises, including orientation, associative memory, word-image association, recall memory, etc.
Participants will be randomly assigned to either Intervention or Control Arm. Participants of Intervention Arm must have access to an iPAD at least for the duration of the study.
Procedure for Intervention Arm The participants in Intervention Arm will have a training session (after obtaining their consent form) for the Brain Exercises. The Brain Fitness App will be downloaded into their iPAD and they will be instructed on how to use it. As mentioned in their consent form, they will commit themselves to play the games on a daily basis for (at least 5 days/week), twice/day, each session of minimum 15 minutes for a period of 4 consecutive weeks.
Procedure for Control Arm Participants of this arm will do nothing but will be assessed at baseline, 4 week and 8 weeks later. Their data will be used as the control data for comparison with the Intervention Arm data. All participants of this group, if interested, will be offered to practice the Brain Fitness App if they wish after their completion of this study (2 months period).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Other: Brain Fitness App4 weeks daily practice of the brain exercises |
| control | No intervention | –no brain exercises |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- MoCA ≥ 25
- Have no known or diagnosis of major depression, bipolar disorder, schizophrenia, mood disorder, Parkinson's disease, dementia of any type, or any other neurological degenerative disease.
- Capable of using an iPAD and access to Internet at home.
- Reading/writing fluency in English
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Brain Fitness AppBrain exercises using an iPAD | Other | Active |
Primary outcome
The change in Wechsler Memory Scale (WMS IV) from baseline
Time frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
This assessment has a total of 11 tests, out of which we will use its six primary tests that assess our target brain functions, comprised of 12 subtests (subsections): Logical Memory 1, Verbal Paired Associates 1, Faces 1, Family Pictures 1, Logical Memory 2, Verbal Paired Associates 2, Faces 2, Family Pictures 2, Verbal Paired Associates 2 Recognition, Logical Memory 2 Recognition, Letter-Number Sequencing and Spatial Span. They are classified into 3 major memory indexes: Immediate Memory, General Memory and Working Memory. The WMS test is being purchased online from the following link; they do not provide a softcopy.
2 secondary outcomes
Change in Egocentric Spatial Orientation
Time frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
Change in MONTGOMERY ASBERG DEPRESSION RATING SCALE (MADRS)
Time frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment
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 24 Feb 2021.
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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 Brain Fitness App in people with Memory Problems, run by University of Manitoba 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 4 inclusion and 0 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 24 Feb 2021. 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. 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?
The change in Wechsler Memory Scale (WMS IV) from baseline (time frame: baseline, post-intervention within a week after the end of 4-week trial and a month after the second assessment). 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 Feb 2021.