Mild Cognitive ImpairmentNCT04023032
Efficacy of a Multicomponent Cognitive Intervention in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments
A study testing multicomponent cognitive intervention in people with Mild Cognitive Impairment and Subjective Cognitive Decline, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Mild Cognitive Impairment, Subjective Cognitive Decline
- What is being tested?
- multicomponent cognitive intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jan 2019to 29 Aug 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 50 years old
- years of education > 6
- mild cognitive impairment or subjective cognitive decline diagnosed by physician
- the Barthel Index scored 100
- the Montreal Cognitive Assessment (MoCA) > 18
- the UPSA-Brief > 50
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: Efficacy of a Multicomponent Cognitive Intervention Program on the Cognitive and Daily Function in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments: A Pilot Study
Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. There are many different types of cognitive interventions, which aim to positively impact the cognitive functioning of an individual and have been classified as cognitive stimulation, cognitive training, and cognitive rehabilitation. However, most studies used neuropsychological cognitive measures for outcome evaluation. The impact of cognitive interventions on daily functional performance among individuals with MCI and SCD were rarely explored. In addition, cognitive training focusing on specific cognitive outcomes is suspected to have limited far transfer to everyday measures. Therefore, a multicomponent intervention which integrates several types of intervention is recommended to reach the maximum impact on daily function.
The purposes of this study are to examine the effects of a multicomponent cognitive intervention on cognitive and daily functional outcomes in individuals with MCI and SCD, and to compare the effects between the two groups. In addition, the investigators will also investigate whether the demographic (e.g., age and educational level, etc.) and clinical variables (e.g., duration of cognitive complains, level of depression and baseline cognitive function, etc.) may affect the outcomes of cognitive intervention.
Read the detailed description
This study is a pretest-posttest design. Thirty-five subjects with MCI and 35 with SCD, who are diagnosed by physicians, will be recruited from the neurology outpatient clinic of National Taiwan University Hospital. All participants will wait for 16 weeks as a historical control and then receive the multicomponent cognitive intervention. The intervention is composed of 14 weekly 1.5-hour group sessions and 2 individual sessions in a 4-month period.
The multicomponent cognitive intervention in this study is a combination of several approaches, including cognitive training, cognitive rehabilitation, lifestyle interventions, and psychological interventions. Cognitive training is an approach which trains patients by repeated practicing to optimize or restore cognitive functions. Cognitive rehabilitation is tailored programs in which therapist usually provides patient strategies focusing on specific activities of daily life. Lifestyle interventions educate and encourage individuals to make changes to their life to balance the risk and protective factors. The strategies can include regular physical exercise, healthy nutrition (i.e., Mediterranean diet), frequent participation in cognitively-stimulating activities, and reduction of smoking and heavy alcohol consumption. Psychological interventions target neuropsychiatric symptoms that are common among individuals with SCD and MCI (e.g., depression, anxiety, fatigue, poor sleep) and thus include relaxation exercises, mindfulness techniques, skills to manage stress and poor sleep, and cognitive behavioral techniques. By using the approaches above together, the investigators hope to improve participants' cognitive and daily function.
All participants will be assessed at four time points: before waiting period (A0), before the intervention (A1), right after the 16-week intervention (A2), and 16 weeks after the intervention (A3). The primary outcomes are the subjective and objective performance of activities of daily living, and the secondary outcomes are the cognitive performance on the neurological tests, anxiety, and depression.
- Being tested
- multicomponent cognitive intervention
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multicomponent cognitive interventionBehavioural
The intervention takes place in groups of 6-10 participants and is leaded by one occupational therapist. It includes 16 sessions, 90 minutes each.
The first part of each session starts with a 15-minute review of previous homework or relaxation. The second part, which lasts 35 minutes, involves structured training with activity-sheets, board games, role-playing and computerized games. The third part, which lasts 30 minutes, is the lifestyle interventions. The instructor explains the generalization of the previous activities toward daily life, and introduces healthy lifestyles. Through group discussions, the therapist guides participants to develop solutions and strategies for their memory or cognition-related problems and application to daily life. The last 10 minutes are used to suggest homework.
| Study group | Role | What they receive |
|---|---|---|
| multicomponent cognitive intervention | Experimental | Not described Receives: Behavioral: multicomponent cognitive intervention |
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 (UPSA-Brief ) (Traditional Chinese Version) at 16 weeks, 32 weeks, and 48 weeks
The UPSA-Brief, which consists of 2 subscales (communication and financial), is a useful performance-based functional outcome scale. It has adequate psychometric properties, predicts residential independence, is sensitive to change, and requires only 10-15 minutes to administer.
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Activities of Daily Living Questionnaire at 16 weeks, 32 weeks, and 48 weeks
The Activities of Daily Living Questionnaire (ADLQ) is an informant-based assessment of functional abilities in patients with probable Alzheimer disease and other forms of dementia. The ADLQ measures functioning in six areas: self-care, household care, employment and recreation, shopping and money, travel, and communication.
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Contextual Memory Test (CMT) at 16 weeks, 32 weeks, and 48 weeks
The CMT is used to objectively measure awareness of memory capacity, strategy use and recall in adults with memory dysfunction. It assess 3 areas of memory including: awareness of memory capacity, recall of line-drawn items, and strategy use.
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Miami Prospective Memory Test (MPMT) at 16 weeks, 32 weeks, and 48 weeks
The Miami Prospective Memory Test evaluates time-related and event-related prospective memory ability of older adults.
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Everyday Memory Questionnaire (EMQ) at 16 weeks, 32 weeks, and 48 weeks
The Everyday Memory Questionnaire (EMQ) was developed as a subjective measure of memory failure in everyday life.
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Cognitive Failure Questionnaire (CFQ) at 16 weeks, 32 weeks, and 48 weeks
The CFQ assesses the frequency with which people experienced cognitive failures in daily life.
Measured: baseline, 16th, 32nd and 48th week
Secondary outcomes (6)
Change from Baseline the Word Sequence Learning Test at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Logical Memory (LM) subtest at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Family Pictures (FP) subtest at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Color Trails Test at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the Geriatric Depression Scale-Short Form (GDS-S) at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Change from Baseline the State-Trait Anxiety Inventory-Situation (STAI-S) at 16 weeks, 32 weeks, and 48 weeks
Measured: baseline, 16th, 32nd and 48th week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2019
- Study start2 Jan 2019
- Primary completion29 Aug 2021
- Study completion29 Aug 2021
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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 28 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
- NCT04023032
- Sponsor's protocol ID
- 201805012RINA
- Status last verified
- Jan 2021
- First submitted
- 15 Jul 2019
- Last updated
- 1 Sep 2021
- 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 1 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Multicomponent Cognitive Intervention Program on the Cognitive and Daily Function in Adults With Subjective Cognitive Decline and Mild Cognitive Impairments: A Pilot Study
- ClinicalTrials.gov ID
- NCT04023032
- Acronym / sponsor ID
- 201805012RINA
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- 29 Aug 2021 (actual)
- First posted
- 17 Jul 2019 (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.
Individuals with mild cognitive impairment (MCI) and subjective cognitive decline (SCD) have greater risk of developing dementia. Cognitive intervention is a topic of great interest in individuals with MCI and SCD for the purpose of preventing or delaying the occurrence of dementia. There are many different types of cognitive interventions, which aim to positively impact the cognitive functioning of an individual and have been classified as cognitive stimulation, cognitive training, and cognitive rehabilitation. However, most studies used neuropsychological cognitive measures for outcome evaluation. The impact of cognitive interventions on daily functional performance among individuals with MCI and SCD were rarely explored. In addition, cognitive training focusing on specific cognitive outcomes is suspected to have limited far transfer to everyday measures. Therefore, a multicomponent intervention which integrates several types of intervention is recommended to reach the maximum impact on daily function.
The purposes of this study are to examine the effects of a multicomponent cognitive intervention on cognitive and daily functional outcomes in individuals with MCI and SCD, and to compare the effects between the two groups. In addition, the investigators will also investigate whether the demographic (e.g., age and educational level, etc.) and clinical variables (e.g., duration of cognitive complains, level of depression and baseline cognitive function, etc.) may affect the outcomes of cognitive intervention.
Detailed description
This study is a pretest-posttest design. Thirty-five subjects with MCI and 35 with SCD, who are diagnosed by physicians, will be recruited from the neurology outpatient clinic of National Taiwan University Hospital. All participants will wait for 16 weeks as a historical control and then receive the multicomponent cognitive intervention. The intervention is composed of 14 weekly 1.5-hour group sessions and 2 individual sessions in a 4-month period.
The multicomponent cognitive intervention in this study is a combination of several approaches, including cognitive training, cognitive rehabilitation, lifestyle interventions, and psychological interventions. Cognitive training is an approach which trains patients by repeated practicing to optimize or restore cognitive functions. Cognitive rehabilitation is tailored programs in which therapist usually provides patient strategies focusing on specific activities of daily life. Lifestyle interventions educate and encourage individuals to make changes to their life to balance the risk and protective factors. The strategies can include regular physical exercise, healthy nutrition (i.e., Mediterranean diet), frequent participation in cognitively-stimulating activities, and reduction of smoking and heavy alcohol consumption. Psychological interventions target neuropsychiatric symptoms that are common among individuals with SCD and MCI (e.g., depression, anxiety, fatigue, poor sleep) and thus include relaxation exercises, mindfulness techniques, skills to manage stress and poor sleep, and cognitive behavioral techniques. By using the approaches above together, the investigators hope to improve participants' cognitive and daily function.
All participants will be assessed at four time points: before waiting period (A0), before the intervention (A1), right after the 16-week intervention (A2), and 16 weeks after the intervention (A3). The primary outcomes are the subjective and objective performance of activities of daily living, and the secondary outcomes are the cognitive performance on the neurological tests, anxiety, and depression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| multicomponent cognitive intervention | Experimental | Behavioral: multicomponent cognitive intervention |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- over 50 years old
- years of education > 6
- mild cognitive impairment or subjective cognitive decline diagnosed by physician
- the Barthel Index scored 100
- the Montreal Cognitive Assessment (MoCA) > 18
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 |
|---|---|---|
| multicomponent cognitive interventionThe intervention takes place in groups of 6-10 participants and is leaded by one occupational therapist. It includes 16 sessions, 90 minutes each. The first part of each session starts with a 15-minute review of previous homework or relaxation. The second part, which lasts 35 minutes, involves structured training with activity-sheets, board games, role-playing and computerized games. The third part, which lasts 30 minutes, is the lifestyle interventions. The instructor explains the generalization of the previous activities toward daily life, and introduces healthy lifestyles. Through group discussions, the therapist guides participants to develop solutions and strategies for their memory or cognition-related problems and application to daily life. The last 10 minutes are used to suggest homework. | Behavioural | multicomponent cognitive intervention |
Primary outcome
Change from Baseline the Brief University of California San Diego (UCSD) Performance-Based Skills Assessment (UPSA-Brief ) (Traditional Chinese Version) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The UPSA-Brief, which consists of 2 subscales (communication and financial), is a useful performance-based functional outcome scale. It has adequate psychometric properties, predicts residential independence, is sensitive to change, and requires only 10-15 minutes to administer.
Change from Baseline the Activities of Daily Living Questionnaire at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The Activities of Daily Living Questionnaire (ADLQ) is an informant-based assessment of functional abilities in patients with probable Alzheimer disease and other forms of dementia. The ADLQ measures functioning in six areas: self-care, household care, employment and recreation, shopping and money, travel, and communication.
Change from Baseline the Contextual Memory Test (CMT) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The CMT is used to objectively measure awareness of memory capacity, strategy use and recall in adults with memory dysfunction. It assess 3 areas of memory including: awareness of memory capacity, recall of line-drawn items, and strategy use.
Change from Baseline the Miami Prospective Memory Test (MPMT) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The Miami Prospective Memory Test evaluates time-related and event-related prospective memory ability of older adults.
Change from Baseline the Everyday Memory Questionnaire (EMQ) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The Everyday Memory Questionnaire (EMQ) was developed as a subjective measure of memory failure in everyday life.
Change from Baseline the Cognitive Failure Questionnaire (CFQ) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
The CFQ assesses the frequency with which people experienced cognitive failures in daily life.
6 secondary outcomes
Change from Baseline the Word Sequence Learning Test at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Logical Memory (LM) subtest at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
Change from Baseline the Wechsler Memory Scale-3rd ed. (WMS-III) Family Pictures (FP) subtest at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
Change from Baseline the Color Trails Test at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
Change from Baseline the Geriatric Depression Scale-Short Form (GDS-S) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
Change from Baseline the State-Trait Anxiety Inventory-Situation (STAI-S) at 16 weeks, 32 weeks, and 48 weeks
Time frame: baseline, 16th, 32nd and 48th week
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 1 Sep 2021.
- 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 multicomponent cognitive intervention in people with Mild Cognitive Impairment and Subjective Cognitive Decline, 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 6 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 1 Sep 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 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 (UPSA-Brief ) (Traditional Chinese Version) at 16 weeks, 32 weeks, and 48 weeks (time frame: baseline, 16th, 32nd and 48th week). The study lists 6 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 1 Sep 2021.