Mild Cognitive ImpairmentNCT03379519
Protocol of Multi-domain Attention Training
A study testing Multi-domain Attention Training (MAT) and Passive information activities (PIA) in people with Mild Cognitive Impairment, run by Ministry of Science and Technology, Taiwan.
Trial summary
This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training . Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Multi-domain Attention Training (MAT) and Passive information activities (PIA)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2016to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
- Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
- Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
- No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family
Who cannot join
- The clinical diagnosis of dementia was based on the DSM-IV-TR
- Active in another cognitive or memory-related training in the past year
- Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
- A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
- Severe losses in vision, hearing, or communicative ability
About this study
Official title: The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment
This study sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .
Read the detailed description
This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Multi-domain Attention Training (MAT), Passive information activities (PIA)
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-domain Attention Training (MAT)Behavioural
Also called Attention training
The training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention.
Passive information activities (PIA)Behavioural
Also called Active control group
The active control group (Passive information activities) training content included reading online e-books and playing online games.
| Study group | Role | What they receive |
|---|---|---|
| Multi-domain Attention Training (MAT) | Experimental | Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions). Receives: Behavioral: Multi-domain Attention Training (MAT) |
| Passive information activities (PIA) | Active comparator | The training sessions of PIA is the same as MAT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). Receives: Behavioral: Passive information activities (PIA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in attention as measured by the Digit Span Task (DS).
The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).
Measured: Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.
Secondary outcomes (1)
Change in attention as measured by the Trail Making Test (TMT).
The secondary outcome indicator is spatial orienting attention evaluated by the Trail Making Test.
Measured: Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months after intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2017
- Study start1 Aug 2016
- Primary completion31 May 2019
- Study completion31 Dec 2019
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ministry of Science and Technology, Taiwan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Yang, Hui-Ling, Ministry of Science and Technology, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03379519
- Sponsor's protocol ID
- N201602069
- Status last verified
- Feb 2020
- First submitted
- 10 Dec 2017
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Evaluation of Multi-domain Attention Training for Older Adults With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03379519
- Acronym / sponsor ID
- N201602069
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ministry of Science and Technology, TaiwanOther government
- Study start
- 1 Aug 2016 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 20 Dec 2017 (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 sought to investigate the changes in attention in older adults with mild cognitive impairment after Multi-domain Attention Training .
Detailed description
This double-blind randomized controlled study has a 2-arm parallel group design. All subjects will be randomized by the block randomization, into intervention group (Multi-domain Attention Training, MAT), or active control group (Passive information activities, PIA). Training sessions of the MAT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of PIA group is the same as MAT group. The investigators constructed a rigorous MAT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. The investigators expect to determine the improvement in attention function of older adults with mild cognitive impairment after using the MAT program.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multi-domain Attention Training (MAT) | Experimental | Behavioral: Multi-domain Attention Training (MAT)Training sessions of the MAT group is 45 minutes/day, 3 sessions/week, for 12 weeks (36 sessions). |
| Passive information activities (PIA) | Active comparator | Behavioral: Passive information activities (PIA)The training sessions of PIA is the same as MAT group (45 min/day, 3 days/week, for 12 weeks, for a total of 36 sessions). |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must endorse at least two items from a list of frequent subjective memory complaints by patient and/or an informant
- Objective memory impairment on neuropsychological tests of memory 1.5 SD or more below age/education norms
- Clinical neurologic examination by the Mini-Mental State Examination (MMSE) score of 24 or higher
- No impairment in personal activities of daily living (P-ADL) as determined by clinical interview with participant and family
Key exclusion criteria (5 listed)
- The clinical diagnosis of dementia was based on the DSM-IV-TR
- Active in another cognitive or memory-related training in the past year
- Comorbid medical conditions that would predispose them to imminent functional decline or cognitive impairment
- A diagnosis of major neurological or psychiatric illness history and/or behavioral problems that would sufficiently impair performance to make participation impossible
- Severe losses in vision, hearing, or communicative ability
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 |
|---|---|---|
| Multi-domain Attention Training (MAT)Also: Attention trainingThe training content emphasis three concept of attention include: intensity of attention, executive attention, and spatial orienting attention. | Behavioural | Multi-domain Attention Training (MAT) |
| Passive information activities (PIA)Also: Active control groupThe active control group (Passive information activities) training content included reading online e-books and playing online games. | Behavioural | Passive information activities (PIA) |
Primary outcome
Change in attention as measured by the Digit Span Task (DS).
Time frame: Change from baseline in executive attention at Immediate post-test, 3 months, 6 months after intervention.
The primary outcome indicators is executive attention assessed by the Digit Span Task (DS).
1 secondary outcome
Change in attention as measured by the Trail Making Test (TMT).
Time frame: Change from baseline in spatial orienting attention at Immediate post-test, 3 months, 6 months 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 20 Feb 2020.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
Recruiting
The Efficacy of an IADL-based Non-immersive Virtual Reality Training Program to Enhance ADL Performance and Cognitive Function for Persons at Risk of Dementia
Cognitive Enhancement, Subjective Cognitive Decline (SCD)
RecruitingPhase 2
Alzheimer's Tau Platform: Master Protocol
Preclinical Alzheimer's Disease, Alzheimer Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Fuzhou Aging Brain Health Initiative
Dementia, Alzheimer Dementia (AD)
Recruiting
Choose Myself (Before) Losing Myself
Dementia (Diagnosis), Mild Cognitive Impairment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-domain Attention Training (MAT) and Passive information activities (PIA) in people with Mild Cognitive Impairment, run by Ministry of Science and Technology, 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 4 inclusion and 5 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 20 Feb 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?
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 in attention as measured by the Digit Span Task (DS). (time frame: Change from baseline in executive attention at Immediate post-test, 3 months, 6 months 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 20 Feb 2020.