Mild Cognitive ImpairmentNCT03430401
Computer-based Cognitive Rehabilitation Program for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
A study testing Perceptual-based memory encoding, Semantic-based memory encoding and Cognitive stimulation in people with Mild Cognitive Impairment and Mild Dementia, run by University of Western Sydney at 1 site in Australia.
Trial summary
This study will adopt a newly developed computer-based cognitive rehabilitation program targeting the encoding stage of memory. The aims of the study are: 1. To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild… 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, Mild Dementia, Healthy Older Adults
- What is being tested?
- Perceptual-based memory encoding, Semantic-based memory encoding and Cognitive stimulation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Aug 2018to 1 Dec 2025
- 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
Selection Criteria for healthy older adults:
- Score greater than 24 on the Mini-Mental State Examination, 2nd edition, standard version (MMSE)
- Score less than 5 on the 15-item Geriatric Depression Scale - Short Form (GDS)
- No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria); and
- Are able to provide voluntary consent to participate in the study.
Selection Criteria for people with MCI:
- No diagnosis of probable dementia (as per NINCDS-ADRDA Alzheimer's Criteria);
- Have a Clinical Dementia Rating Score (CDR) of 0 indicating no dementia;
- Meets the diagnostic criteria for MCI (Petersen, 2004); and
- Are able to provide voluntary consent to participate in the study.
Selection Criteria for people with mild dementia:
- Have a diagnosis of probable dementia;
- Have a CDR score of 1 indicating mild dementia;
- Have a career or family members who are able to report functional performance; and
- Are able to provide voluntary consent to participate in the study, or have a guardian to provide consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Computer-based Cognitive Rehabilitation Program to Improve Cognition and Delay Deterioration in Functional Performance for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
This study will adopt a newly developed computer-based cognitive rehabilitation program targeting the encoding stage of memory. The aims of the study are:
- To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild dementia.
- To test the effectiveness of the newly developed program in improving cognitive function and enabling maintenance of occupational performance in healthy older adults, people with MCI or mild dementia.
Using an iPad application, study participants will learn a memory encoding strategy to support completion of their daily activities. By implementing memory encoding strategies during the mild stages of cognitive decline, the project aims to prolong independence in functional performance. It is anticipated that adoption of the same memory strategies will enable maintain performance as they may experience ongoing cognitive decline.
Read the detailed description
This study extends on the positive results of a pilot study (Lim et al., 2012) which demonstrated the effectiveness of a cognitive training program combined with perceptual and semantic memory encoding strategies. Following the intervention phase of the pilot study, elements of cognition were examined using standardised assessments. The participants showed improved general attention (p = 0.03), memory (p = 0.03) and cognitive function including naming (p = 0.02), construction (p = 0.01), memory (p = 0.02) and similarities (p = 0.001) all of which are necessary for functioning in daily activities. However, due to the combination of strategies used during the pilot study, the isolated effect of perceptual and semantic memory encoding strategies could not be determined. It has been found that the effects of aging impact negatively on both semantic and perceptual encoding. However, with age, there tends to be a greater impact on an individual's ability to use perceptual encoding strategies in comparison to those of semantic (Kuo, Liu, Ting, \& Chan, 2014). This varies in the case of individuals in the early stages of Alzheimer's disease in which many individuals will show progressive impairment in semantic memory (Hodges \& Patterson, 1995). As dementia has been positively correlated with Mild Cognitive Impairment (MCI) but not often diagnosed until much later in the course of the disease and as not all individuals with MCI will progress to dementia it would be beneficial prior to undertaking a memory encoding intervention program to understand if an individual would benefit greater from undertaking a semantic or a perceptual memory encoding rehabilitation approach. Although it may be easy for a healthy adult to report their preference in encoding style, an individual with MCI or mild dementia may find this more difficult due to the abstract complexity of the concepts. As it is known that not all cases of MCI progress to dementia, this study aims at identifying if individuals with MCI or mild dementia will benefit from intervention based on both semantic and perceptual encoding styles.
In addition, given the benefit and successful use of computer-based programs in elderly, this study will develop the memory encoding training program into a user-friendly computer-based program in healthy older adults, older adults with MCI or mild dementia will be able to use under the guidance of rehabilitation professionals.
- Being tested
- Perceptual-based memory encoding, Semantic-based memory encoding, Cognitive stimulation
- Keywords
- memory encoding, functional performance
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perceptual-based memory encodingBehavioural
It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.
In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention.
Semantic-based memory encodingBehavioural
It will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional.
In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention.
Cognitive stimulationBehavioural
The frequency, duration and the number of sessions will be consistent with the experimental interventions.
| Study group | Role | What they receive |
|---|---|---|
| Perceptual-based memory encoding | Experimental | It will involve the use of visual imagery and the method of loci. To achieve this, each of the 15 daily tasks will be filmed and a short video created. In addition, each task will be broken down into 5-6 photographed steps based on activity analysis and task breakdown. The program will prompt the user to indicate in which room of the house the task would usually be completed. Once correct location is identified, the program will prompt the user to watch a chosen daily task video and then visualise themselves completing the task in their home environment. Receives: Behavioral: Perceptual-based memory encoding |
| Semantic-based memory encoding | Experimental | It will incorporate association-based strategies to assist with recalling the steps of daily tasks. The steps of a given daily task will be provided and the user will be prompted to link the steps using a honeycomb concept, which makes use of the chunking method to encode the sequenced steps. Following this, the program will prompt the user to categorise the steps according to their association with given words cues. The word cues will represent time, places, objects, and people. The program will then take the user response and form a verbal and visual story according to the responses given. The program will help identify any problems in the sequencing and prompt the user to re-categorise if required. Receives: Behavioral: Semantic-based memory encoding |
| Cognitive stimulation | Active comparator | Participants will complete an online cognitive exercise program, Lumosity (Sarkar, Scanlon, \& Drescher, 2007). A study conducted by Hardy, Drescher, Sarkar, Kellett, and Scanlon (2011) indicated that participants who engaged in Lumosity showed greater improvements in memory in comparison to a non-intervention control group. Receives: Behavioral: Cognitive stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability Assessment for Dementia - Change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Secondary outcomes (3)
Color Trails Test - Change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Behavior Rating Inventory of Executive Function - Change from baseline after the intervention
Measured: Baseline and after the intervention (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2018
- Study start1 Aug 2018
- Primary completion31 Aug 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Western Sydney
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karen Liu, University of Western Sydney
- Investigators
- Karen P.Y. Liu, PhD, Principal investigator, Western Sydney University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03430401
- Sponsor's protocol ID
- UWesternSydney
- Status last verified
- May 2024
- First submitted
- 5 Feb 2018
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tulliani N, Bye R, Bissett M, Coutts S, Liu KPY. The feasibility and acceptability of an app-based cognitive strategy training programme for older people. Pilot Feasibility Stud. 2023 Jun 30;9(1):109. doi: 10.1186/s40814-023-01334-x.
PubMed 37391842
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computer-based Cognitive Rehabilitation Program to Improve Cognition and Delay Deterioration in Functional Performance for Healthy Older Adults, Older People With Mild Cognitive Impairment and Mild Dementia
- ClinicalTrials.gov ID
- NCT03430401
- Acronym / sponsor ID
- UWesternSydney
- Keywords
- memory encoding, functional performance
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Western SydneyUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Feb 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.
This study will adopt a newly developed computer-based cognitive rehabilitation program targeting the encoding stage of memory. The aims of the study are:
- To test the feasibility of conducting a newly developed computer-based cognitive rehabilitation program for healthy older adults, people with MCI and mild dementia.
- To test the effectiveness of the newly developed program in improving cognitive function and enabling maintenance of occupational performance in healthy older adults, people with MCI or mild dementia.
Using an iPad application, study participants will learn a memory encoding strategy to support completion of their daily activities. By implementing memory encoding strategies during the mild stages of cognitive decline, the project aims to prolong independence in functional performance. It is anticipated that adoption of the same memory strategies will enable maintain performance as they may experience ongoing cognitive decline.
Detailed description
This study extends on the positive results of a pilot study (Lim et al., 2012) which demonstrated the effectiveness of a cognitive training program combined with perceptual and semantic memory encoding strategies. Following the intervention phase of the pilot study, elements of cognition were examined using standardised assessments. The participants showed improved general attention (p = 0.03), memory (p = 0.03) and cognitive function including naming (p = 0.02), construction (p = 0.01), memory (p = 0.02) and similarities (p = 0.001) all of which are necessary for functioning in daily activities. However, due to the combination of strategies used during the pilot study, the isolated effect of perceptual and semantic memory encoding strategies could not be determined. It has been found that the effects of aging impact negatively on both semantic and perceptual encoding. However, with age, there tends to be a greater impact on an individual's ability to use perceptual encoding strategies in comparison to those of semantic (Kuo, Liu, Ting, \& Chan, 2014). This varies in the case of individuals in the early stages of Alzheimer's disease in which many individuals will show progressive impairment in semantic memory (Hodges \& Patterson, 1995). As dementia has been positively correlated with Mild Cognitive Impairment (MCI) but not often diagnosed until much later in the course of the disease and as not all individuals with MCI will progress to dementia it would be beneficial prior to undertaking a memory encoding intervention program to understand if an individual would benefit greater from undertaking a semantic or a perceptual memory encoding rehabilitation approach. Although it may be easy for a healthy adult to report their preference in encoding style, an individual with MCI or mild dementia may find this more difficult due to the abstract complexity of the concepts. As it is known that not all cases of MCI progress to dementia, this study aims at identifying if individuals with MCI or mild dementia will benefit from intervention based on both semantic and perceptual encoding styles.
In addition, given the benefit and successful use of computer-based programs in elderly, this study will develop the memory encoding training program into a user-friendly computer-based program in healthy older adults, older adults with MCI or mild dementia will be able to use under the guidance of rehabilitation professionals.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Perceptual-based memory encoding | Experimental | Behavioral: Perceptual-based memory encodingIt will involve the use of visual imagery and the method of loci. To achieve this, each of the 15 daily tasks will be filmed and a short video created. In addition, each task will be broken down into 5-6 photographed steps based on activity analysis and task breakdown. The program will prompt the user to indicate in which room of the house the task would usually be completed. Once correct location is identified, the program will prompt the user to watch a chosen daily task video and then visualise themselves completing the task in their home environment. |
| Semantic-based memory encoding | Experimental | Behavioral: Semantic-based memory encodingIt will incorporate association-based strategies to assist with recalling the steps of daily tasks. The steps of a given daily task will be provided and the user will be prompted to link the steps using a honeycomb concept, which makes use of the chunking method to encode the sequenced steps. Following this, the program will prompt the user to categorise the steps according to their association with given words cues. The word cues will represent time, places, objects, and people. The program will then take the user response and form a verbal and visual story according to the responses given. The program will help identify any problems in the sequencing and prompt the user to re-categorise if required. |
| Cognitive stimulation | Active comparator | Behavioral: Cognitive stimulationParticipants will complete an online cognitive exercise program, Lumosity (Sarkar, Scanlon, \& Drescher, 2007). A study conducted by Hardy, Drescher, Sarkar, Kellett, and Scanlon (2011) indicated that participants who engaged in Lumosity showed greater improvements in memory in comparison to a non-intervention control group. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
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 |
|---|---|---|
| Perceptual-based memory encodingIt will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional. In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention. | Behavioural | Perceptual-based memory encoding |
| Semantic-based memory encodingIt will run for 12 weeks with a 1-hour training session each week, supervised by a rehabilitation professional. In addition, two 30-minute home-based training sessions will be completed by participants. In the home training session, participants will practice specific daily tasks that are covered in the previous professional-led session through the use of the computer-based intervention. | Behavioural | Semantic-based memory encoding |
| Cognitive stimulationThe frequency, duration and the number of sessions will be consistent with the experimental interventions. | Behavioural | Cognitive stimulation |
Primary outcome
Disability Assessment for Dementia - Change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Lawton and Brody Instrumental Activities of Daily Living Scale - Change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
3 secondary outcomes
Color Trails Test - Change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Repeatable Battery for the Assessment of Neuropsychological Status - Change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Behavior Rating Inventory of Executive Function - Change from baseline after the intervention
Time frame: Baseline and after the intervention (12 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- Derived from this study: PubMed 37391842Tulliani N, Bye R, Bissett M, Coutts S, Liu KPY. The feasibility and acceptability of an app-based cognitive strategy training programme for older people. Pilot Feasibility Stud. 2023 Jun 30;9(1):109. doi: 10.1186/s40814-023-01334-x.
- 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.
Karen P.Y. Liu, PhD principal investigator
Western Sydney University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perceptual-based memory encoding, Semantic-based memory encoding and Cognitive stimulation in people with Mild Cognitive Impairment and Mild Dementia, run by University of Western Sydney at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 8 May 2024. 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 Australia. 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?
Results are not available in the source record.
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?
Disability Assessment for Dementia - Change from baseline after the intervention (time frame: Baseline and after the intervention (12 weeks)). The study lists 2 primary outcomes in all. 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 NCT03430401, which also lists 1 linked publication.
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 8 May 2024.