Mild Cognitive ImpairmentNCT02785315
Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment
A study testing rehabilitation & remediation approach and remediation approach in people with Mild Cognitive Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
People with mild cognitive impairment (MCI) are at a greater risk of developing dementia. Therefore, it is important to develop effective non-pharmacological interventions to facilitate their cognitive and activities of daily living (ADL) function, which will also prevent or delay their progression to dementia and… Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- rehabilitation & remediation approach and remediation approach
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteTaiwan
- Study dates
- 16 Dec 2014to 14 Nov 2017
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- without concurrent major or significant psychiatric disorders
- severe physical diseases which might affect cognitive functions
- difficult to follow instructions due to visual or hearing impairments
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment: The Efficacy in Enhancement of Cognition and Complex Activities of Daily Living Function
People with mild cognitive impairment (MCI) are at a greater risk of developing dementia. Therefore, it is important to develop effective non-pharmacological interventions to facilitate their cognitive and activities of daily living (ADL) function, which will also prevent or delay their progression to dementia and reduce associated healthcare and social costs. There are currently a variety of cognitive interventions, mainly categorized as remediation and rehabilitation approach. Research to compare their contents and effectiveness is strongly needed. The information can be used to individualize cognitive intervention based on specific cognitive profile of the patient.
This study aims to determine the immediate and long-term efficacy of the remediation approach and rehabilitation approach in enhancing the cognitive and ADL function. The research questions include 1) whether the rehabilitation approach compared with the remediation approach has better effects on improving ADL function; (2) whether the remediation approach may only enhance the performance on the cognitive tests rather than on the ADL function. This study will also explore whether the attitudes of caregivers on providing ADL assistance affect effects of cognitive intervention.
Read the detailed description
The study is designed by a single-blinded randomized control trial. Sixty persons with MCI, confirmed by physicians, will receive 12 weekly 90-minute cognition interventions in a group of 6-8 persons. All participants will be randomly assigned to the following groups: 1) Remediation approach: various cognitive strategies will be taught, and exercises involving the practice of these strategies to enhance the attention, memory, processing speed, and executive functions. 2) Combination of rehabilitation and remediation approaches: The first half of each session will focus on the remediation approach as described above. The second half of the session will apply rehabilitation approach. The investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. The investigators will also include one individual session in the 12 group sessions.
All participants will be assessed at 3 time points: before intervention, right after intervention, and 12 weeks after the intervention. The primary outcomes are the ADL functions evaluated by subjective and objective measures, and cognitive function evaluated by tests of attention, memory and executive function. The secondary outcomes include the depression, the quality of life of the participants, and the caregivers' load. The intervention effects will be further analyzed by the caregivers' attitude regarding to the level of ADL assistance.
- Conditions
- Mild Cognitive Impairment
- Being tested
- rehabilitation & remediation approach, remediation approach
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rehabilitation & remediation approachBehavioural
The rehabilitation \& remediation approach group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention by discussing everyday situations with memory problem and specific strategies related to real-life situations. Investigators will also include one individual session in the 12 group sessions.
remediation approachBehavioural
The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions.
| Study group | Role | What they receive |
|---|---|---|
| rehabilitation & remediation approach | Experimental | The intervention group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention with various compensatory strategies. Investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. Investigators will also include one individual session in the 12 group sessions. Receives: Behavioral: rehabilitation & remediation approach |
| remediation approach | Active comparator | The remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. Receives: Behavioral: remediation approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment （Traditional Chinese Version）（UPSA-Brief ) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Secondary outcomes (13)
Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Color Trails Test at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Structure MRI at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks
PiB-PET: Pittsburgh Compound B-Positron Emission Tomography FDG-PET:18-Fluoro-deoxyglucose positron emission tomography
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks
Measured: baseline, 12th and 24th weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2016 (estimated)
- Study start16 Dec 2014
- Primary completion14 Nov 2017
- Study completion14 Nov 2017
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.
- More trials run by National Taiwan University HospitalThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hui-Fen Mao, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02785315
- Sponsor's protocol ID
- 201402028RINC
- Status last verified
- Mar 2019
- First submitted
- 18 May 2016
- Last updated
- 14 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Intervention for Persons With Amnestic Mild Cognitive Impairment: The Efficacy in Enhancement of Cognition and Complex Activities of Daily Living Function
- ClinicalTrials.gov ID
- NCT02785315
- Acronym / sponsor ID
- 201402028RINC
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 16 Dec 2014 (actual)
- Primary completion
- 14 Nov 2017 (actual)
- Study completion
- 14 Nov 2017 (actual)
- First posted
- 27 May 2016 (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.
People with mild cognitive impairment (MCI) are at a greater risk of developing dementia. Therefore, it is important to develop effective non-pharmacological interventions to facilitate their cognitive and activities of daily living (ADL) function, which will also prevent or delay their progression to dementia and reduce associated healthcare and social costs. There are currently a variety of cognitive interventions, mainly categorized as remediation and rehabilitation approach. Research to compare their contents and effectiveness is strongly needed. The information can be used to individualize cognitive intervention based on specific cognitive profile of the patient.
This study aims to determine the immediate and long-term efficacy of the remediation approach and rehabilitation approach in enhancing the cognitive and ADL function. The research questions include 1) whether the rehabilitation approach compared with the remediation approach has better effects on improving ADL function; (2) whether the remediation approach may only enhance the performance on the cognitive tests rather than on the ADL function. This study will also explore whether the attitudes of caregivers on providing ADL assistance affect effects of cognitive intervention.
Detailed description
The study is designed by a single-blinded randomized control trial. Sixty persons with MCI, confirmed by physicians, will receive 12 weekly 90-minute cognition interventions in a group of 6-8 persons. All participants will be randomly assigned to the following groups: 1) Remediation approach: various cognitive strategies will be taught, and exercises involving the practice of these strategies to enhance the attention, memory, processing speed, and executive functions. 2) Combination of rehabilitation and remediation approaches: The first half of each session will focus on the remediation approach as described above. The second half of the session will apply rehabilitation approach. The investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. The investigators will also include one individual session in the 12 group sessions.
All participants will be assessed at 3 time points: before intervention, right after intervention, and 12 weeks after the intervention. The primary outcomes are the ADL functions evaluated by subjective and objective measures, and cognitive function evaluated by tests of attention, memory and executive function. The secondary outcomes include the depression, the quality of life of the participants, and the caregivers' load. The intervention effects will be further analyzed by the caregivers' attitude regarding to the level of ADL assistance.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| rehabilitation & remediation approach | Experimental | Behavioral: rehabilitation & remediation approachThe intervention group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention with various compensatory strategies. Investigators will use group discussion to discuss everyday situations with memory problem and specific strategies (internal and external) related to real-life situations. Investigators will also include one individual session in the 12 group sessions. |
| remediation approach | Active comparator | Behavioral: remediation approachThe remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- without concurrent major or significant psychiatric disorders
- severe physical diseases which might affect cognitive functions
- difficult to follow instructions due to visual or hearing impairments
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 |
|---|---|---|
| rehabilitation & remediation approachThe rehabilitation \& remediation approach group will receive 12 weekly 90-minute combined cognition interventions in a group. The first half of each session will be cognitive training which focus on teaching various cognitive strategies to enhance the attention, memory, processing speed, and executive functions. The second half of the session will apply rehabilitation intervention by discussing everyday situations with memory problem and specific strategies related to real-life situations. Investigators will also include one individual session in the 12 group sessions. | Behavioural | rehabilitation & remediation approach |
| remediation approachThe remediation approach will receive 12 weekly 90-minute cognitive training which focus on teaching various cognitive strategies and their applications to enhance the attention, memory, processing speed, and executive functions. | Behavioural | remediation approach |
Primary outcome
Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment （Traditional Chinese Version）（UPSA-Brief ) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
13 secondary outcomes
Change from Baseline Short-form Zarit Caregiver Burden Interview-12 (sCZBI-12) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Montreal Cognitive Assessment (MoCA) Taiwan Version at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Word Sequence Learning Test at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Minimal-Mental Status Exam (MMSE) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Miami Prospective Memory Test (MPMT) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Color Trails Test at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Structure MRI at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline PiB-PET and FDG-PET at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline amyloid Aβ40, Aβ42 and tau proteins at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline The Disability Assessment for Dementia (DAD) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Quality of Life-Alzheimer's Disease scale (QoL-AD) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Goal Attainment Scaling (GAS) at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
Change from Baseline Everyday Memory Questionnaire at the 12th and 24th weeks
Time frame: baseline, 12th and 24th weeks after intervention
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 14 Mar 2019.
- 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.
Hui-Fen Mao principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing rehabilitation & remediation approach and remediation approach in people with Mild Cognitive Impairment, run by National Taiwan University Hospital at 1 site in Taiwan.
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 0 inclusion and 3 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 14 Mar 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 Taiwan. 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?
Change from Baseline The Brief University of California San Diego (UCSD) Performance-Based Skills Assessment （Traditional Chinese Version）（UPSA-Brief ) at the 12th and 24th weeks (time frame: baseline, 12th and 24th weeks after intervention). 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 14 Mar 2019.