Mild Cognitive ImpairmentNCT04539132
Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training
A study testing ABI Wellness Program in people with Mild Cognitive Impairment, run by Kwantlen Polytechnic University.
Trial summary
Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- ABI Wellness Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2020to 31 Oct 2021
- 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
- T-MoCA score between 19 - 23
Who cannot join
- Potential participants are under the age of 65 years at the time of screening
- Scoring results in a range outside of 19-23 on the MoCA
- Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition
- Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.
Trial locations and contacts
No sites are listed yet.
About this study
Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. The consequences of these progressive diseases increase the requirement for residential care, associated medical costs and may negatively impact the overall quality of life and mental health for individuals. According to the Alzheimer Society of Canada, over the next few decades, more than 1 million Canadian's will be living with decreased cognitive ability and will require an increased amount of support, whether through family or institutional sources.
Currently, there are few cognitive programs for individuals diagnosed with mild cognitive impairment or for individuals wishing to maintain their current level of cognitive ability which translates to meaningful improvements in daily living and independence, as well as generalized intelligence. To date, the Watson Centre Society for Brain Health (WCSBH) has successfully improved cognitive capacity, executive function and quality of life for over 100 individuals following a wide range of brain injury, and currently has a 77% return to work rate following completion of the full program. The program includes a combination of physical exercise, cognitive training and mindfulness meditation.
The purpose of the research study is to explore the impact of an interdisciplinary cognitive rehabilitation program has upon the cognitive functioning and quality of life for individuals who are assessed to have mild cognitive impairment (MCI). In particular, the aims of this study include: 1) To evaluate changes in cognition and quality life in older adults with MCI. 2) To explore the potential for intensive cognitive intervention in slowing cognitive degeneration in older adults with MCI.
- Conditions
- Mild Cognitive Impairment
- Being tested
- ABI Wellness Program
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ABI Wellness ProgramBehavioural
The ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | The "intervention group" will participate in the 6-month interdisciplinary comprehensive rehabilitation program. The ABI Wellness (ABIW) program aimed at this population would be 7 hours a week (2 days per week will be scheduled for the intervention group), consisting of around 4 hours of cognitive training (through specified drills, cognitive exercises focused on executive functioning), 1 hour of physical exercise, 1 hour of mindfulness sessions (meditation) and scheduled break times. Receives: Behavioral: ABI Wellness Program |
| Control Group | No intervention | The "non-intervention" group or control group will have all the same pre-tests administered as the intervention group, however, will not participate in the cognitive program. The control group will be required to complete the assessment periods only, however, keep a record of their daily activities in a log format which is presented in the materials included herein. No other intervention or programming will be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment
Telephone Montreal Cognitive Assessment (T- MoCA) - non-invasive screening tool which takes approximately 10 minutes to complete. Thirty items assessing multiple cognitive domains are contained in the MoCa: short-term memory; visuospatial abilities via clock drawing; and a cube copy task; executive functioning via an adaptation of Trail Making phonemic fluency, and verbal abstraction; attention, concentration, and working memory via target detection, serial subtraction, digits forward, and digits backward; language via confrontation naming with low-familiarity animals, and repetition of complex sentences; and orientation to time and place (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total.
Measured: Pre-post assessment completed 6 months apart with a 6 month follow up
Memory Alteration Test
Memory Alteration Test (M@T) - A non-invasive memory screening test used to discriminate between subjects with subjective memory complaints (SMC) Without objective memory impairment and patients with amnesic mild cognitive impairment (A-MCI) and with Mild Alzheimers disease (AD). (M@T), which is a memory screening test, capable for discriminating between subjects with subjective memory complaints (SMC) (without objective memory impairment) and patients with amnestic mild cognitive impairment (A-MCI) and with mild Alzheimer's disease (AD). This is a cognitive test with high internal consistency and validity, short application (5-10 min), easy to perform and to interpret (Carnero-Pardo et al., 2011a).
Measured: Pre-post assessment completed 6 months apart with a 6 month follow up
Mild Cognitive Impairment Questionnaire
Mild Cognitive Impairment Questionnaire (MCQ) -QOL will be measured using the 13-item MCQ tool designed to take 5 minutes to administer. The MCQ tool uses a scale of 0-4 (none, rarely, sometimes, often, or always) to assess two constructs - Practical Concerns and Emotional Concerns. Scores are transformed and presented on a metric of 0 (no problems) to 100 (maximum impact of MCI). Scale scores are interpreted using the following guide: a scale score of 0-20 indicates 'never' experiencing the issue, 21-40 'rarely' experiencing it, 41-60 'sometimes' experiencing it,61-80 'often' experiencing it, 81-100 'always' experiencing it. The MCQ has been shown to have great stability and reliability through test-retest and substantial validity with this population.
Measured: Pre-post assessment completed 6 months apart with a 6 month follow up
Neuro-QOL
Neuro-QOL This research tool measures the physical, mental, and social effects experienced by adults with neurological conditions. The measurement takes approximately 30 minutes to complete and will be administered three times.
Measured: Pre-post assessment completed 6 months apart with a 6 month follow up
Secondary outcomes (1)
Qualitative Interviews
Interviews - Semi-structured interviews will occur with all participants in the study including the intervention and the control group with a focus upon lived experience specific to quality of life.
Measured: Pre-post assessment completed 6 months apart with a 6 month follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2020
- Study start1 Sep 2020 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Oct 2021 (estimated)
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants will be divided into two groups (N = 20). One group will be the "intervention group" who will participate in the 6-month interdisciplinary comprehensive rehabilitation program whereas the "non-intervention" group or control group will have all of the same pre-tests administered as the intervention group, however, will not participate in the cognitive program.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kwantlen Polytechnic University
- Sponsor type
- University, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, ABI Wellness, Watson Centre Society for Brain Health
- Responsible party
- Sponsor
- Investigators
- Tess Kroeker, PhD, Principal investigator, Kwantlen Polytechnic UniversityShaun Porter, MSc, Study director, ABI Wellness
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04539132
- Sponsor's protocol ID
- 103298
- Status last verified
- Aug 2020
- First submitted
- 31 Aug 2020
- Last updated
- 4 Sep 2020
- 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 4 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maintaining Independence and Quality of Life in Aging Adults Through Targeted Cognitive Training
- ClinicalTrials.gov ID
- NCT04539132
- Acronym / sponsor ID
- 103298
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Kwantlen Polytechnic UniversityUniversity, hospital or other
- Collaborators
- Centre for Aging and Brain Health Innovation, ABI Wellness, Watson Centre Society for Brain Health
- Study start
- 1 Sep 2020 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Oct 2021 (estimated)
- First posted
- 4 Sep 2020 (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.
Mild Cognitive Impairment, Alzheimer's Disease and Parkinson's Disease all represent a range of degenerative conditions that have cognitive impairments which all limit the ability for older individuals to self-manage care, participate in daily activities and community participation. The consequences of these progressive diseases increase the requirement for residential care, associated medical costs and may negatively impact the overall quality of life and mental health for individuals. According to the Alzheimer Society of Canada, over the next few decades, more than 1 million Canadian's will be living with decreased cognitive ability and will require an increased amount of support, whether through family or institutional sources.
Currently, there are few cognitive programs for individuals diagnosed with mild cognitive impairment or for individuals wishing to maintain their current level of cognitive ability which translates to meaningful improvements in daily living and independence, as well as generalized intelligence. To date, the Watson Centre Society for Brain Health (WCSBH) has successfully improved cognitive capacity, executive function and quality of life for over 100 individuals following a wide range of brain injury, and currently has a 77% return to work rate following completion of the full program. The program includes a combination of physical exercise, cognitive training and mindfulness meditation.
The purpose of the research study is to explore the impact of an interdisciplinary cognitive rehabilitation program has upon the cognitive functioning and quality of life for individuals who are assessed to have mild cognitive impairment (MCI). In particular, the aims of this study include: 1) To evaluate changes in cognition and quality life in older adults with MCI. 2) To explore the potential for intensive cognitive intervention in slowing cognitive degeneration in older adults with MCI.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The participants will be divided into two groups (N = 20). One group will be the "intervention group" who will participate in the 6-month interdisciplinary comprehensive rehabilitation program whereas the "non-intervention" group or control group will have all of the same pre-tests administered as the intervention group, however, will not participate in the cognitive program.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: ABI Wellness ProgramThe "intervention group" will participate in the 6-month interdisciplinary comprehensive rehabilitation program. The ABI Wellness (ABIW) program aimed at this population would be 7 hours a week (2 days per week will be scheduled for the intervention group), consisting of around 4 hours of cognitive training (through specified drills, cognitive exercises focused on executive functioning), 1 hour of physical exercise, 1 hour of mindfulness sessions (meditation) and scheduled break times. |
| Control Group | No intervention | –The "non-intervention" group or control group will have all the same pre-tests administered as the intervention group, however, will not participate in the cognitive program. The control group will be required to complete the assessment periods only, however, keep a record of their daily activities in a log format which is presented in the materials included herein. No other intervention or programming will be provided. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- T-MoCA score between 19 - 23
Key exclusion criteria (4 listed)
- Potential participants are under the age of 65 years at the time of screening
- Scoring results in a range outside of 19-23 on the MoCA
- Those who have have a diagnosed illness or diagnosed injury which is known to directly and negatively impact cognition
- Are known (legally) to be deemed incapable; unable to appreciate information that is relevant to making decisions or is unable to appreciate the reasonably foreseeable consequences of either making or not making a decision.
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 |
|---|---|---|
| ABI Wellness ProgramThe ABI Wellness program includes a computerized task which will be completed by all participants remotely. The exercise is a sustained visual-spatial processing task of progressively increasing difficulty. Subjects are presented with an analog clock face, initially showing only one hand. The subject uses a keyboard to enter a value for the hour shown. Feedback on the computer screen indicates whether the response is correct or incorrect. If the response was incorrect, the subject continues to respond until the correct response is entered. After this, a new clock face is shown. Once subjects reach a criterion of 90% accuracy over a series of consecutive responses, an additional hand is added to the clock face. Participants will complete the program at home, online, and will be required to be present on a video call during the exercise with the other participants and research assistants. The program is 150 hours over 6 months, through twice weekly 3-hour sessions. | Behavioural | Intervention Group |
Primary outcome
Montreal Cognitive Assessment
Time frame: Pre-post assessment completed 6 months apart with a 6 month follow up
Telephone Montreal Cognitive Assessment (T- MoCA) - non-invasive screening tool which takes approximately 10 minutes to complete. Thirty items assessing multiple cognitive domains are contained in the MoCa: short-term memory; visuospatial abilities via clock drawing; and a cube copy task; executive functioning via an adaptation of Trail Making phonemic fluency, and verbal abstraction; attention, concentration, and working memory via target detection, serial subtraction, digits forward, and digits backward; language via confrontation naming with low-familiarity animals, and repetition of complex sentences; and orientation to time and place (Nasreddine et al., 2005). The MoCA is scored by obtaining an item total.
Memory Alteration Test
Time frame: Pre-post assessment completed 6 months apart with a 6 month follow up
Memory Alteration Test (M@T) - A non-invasive memory screening test used to discriminate between subjects with subjective memory complaints (SMC) Without objective memory impairment and patients with amnesic mild cognitive impairment (A-MCI) and with Mild Alzheimers disease (AD). (M@T), which is a memory screening test, capable for discriminating between subjects with subjective memory complaints (SMC) (without objective memory impairment) and patients with amnestic mild cognitive impairment (A-MCI) and with mild Alzheimer's disease (AD). This is a cognitive test with high internal consistency and validity, short application (5-10 min), easy to perform and to interpret (Carnero-Pardo et al., 2011a).
Mild Cognitive Impairment Questionnaire
Time frame: Pre-post assessment completed 6 months apart with a 6 month follow up
Mild Cognitive Impairment Questionnaire (MCQ) -QOL will be measured using the 13-item MCQ tool designed to take 5 minutes to administer. The MCQ tool uses a scale of 0-4 (none, rarely, sometimes, often, or always) to assess two constructs - Practical Concerns and Emotional Concerns. Scores are transformed and presented on a metric of 0 (no problems) to 100 (maximum impact of MCI). Scale scores are interpreted using the following guide: a scale score of 0-20 indicates 'never' experiencing the issue, 21-40 'rarely' experiencing it, 41-60 'sometimes' experiencing it,61-80 'often' experiencing it, 81-100 'always' experiencing it. The MCQ has been shown to have great stability and reliability through test-retest and substantial validity with this population.
Neuro-QOL
Time frame: Pre-post assessment completed 6 months apart with a 6 month follow up
Neuro-QOL This research tool measures the physical, mental, and social effects experienced by adults with neurological conditions. The measurement takes approximately 30 minutes to complete and will be administered three times.
1 secondary outcome
Qualitative Interviews
Time frame: Pre-post assessment completed 6 months apart with a 6 month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2020.
- 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. This study is not recruiting at the moment.
Tess Kroeker, PhD principal investigator
Kwantlen Polytechnic University
Shaun Porter, MSc study director
ABI Wellness
Questions about this trial
What is this clinical trial studying?
A study testing ABI Wellness Program in people with Mild Cognitive Impairment, run by Kwantlen Polytechnic University.
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 4 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 4 Sep 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tess Kroeker, PhD (7788778050, Tess.Kroeker@kpu.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (time frame: Pre-post assessment completed 6 months apart with a 6 month follow up). The study lists 4 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 4 Sep 2020.