Mild Cognitive ImpairmentNCT03577717
Efficacy of Computerized Cognitive Training in the Elderly With Mild Cognitive Impairment
A study testing computerized cognitive training and occupational therapy in people with Mild Cognitive Impairment, run by Taipei Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Mild cognitive impairment (MCI) is the prodrome of the cognitive function declining before Alzheimer's disease or other dementia showed up, the impairments of language, visuospatial relationship, attention, and memory included and instrumental activities of daily living (IADL) influenced. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- computerized cognitive training and occupational therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteTaiwan
- Study dates
- 13 Jul 2018to 11 Mar 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- (1) were aged ≥65 years
- (2) amnestic type MCI was made using National Institute on Aging-Alzheimer's Association workgroups diagnostic guidelines for Alzheimer's disease with the clinical dementia rating scale (CDR) global scores of 0.5
- (3) could follow command, understand the content of the assessments, and cooperate with treatment interventions through verbal communication
Who cannot join
- (1) had the score of Geriatric Depression Scale-Short Form (GDS-SF) > 7, indicating depression status
- (2) had the score of Barthel Index (BI)≠100, indicating dependent basic daily living of activities
- (3) were diagnosed with other MCI subtypes, including frontotemporal dementia or Lewy Body those present typically different MCI syndromes
- (4) had other neuropsychotic diseases
- (5) could not administrate with MEG
- (6) could not participate due to severe health problem
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, 24213
About this study
Official title: Efficacy of Computerized Cognitive Training in the Elderly With Mild Cognitive Impairment: Clinical Outcomes and Magnetoencephalographic Imaging
Mild cognitive impairment (MCI) is the prodrome of the cognitive function declining before Alzheimer's disease or other dementia showed up, the impairments of language, visuospatial relationship, attention, and memory included and instrumental activities of daily living (IADL) influenced. MCI is considered as a transitional stage between normal aging and mild dementia, and the patients with MCI has differently fluctuated cognitive functions in a period of time, such as from normal cognition to MCI or developing to dementia. The annual conversion rate (ACR) of older adults with normal cognition developed to MCI is 30%, and 5% in clinical setting, and community, respectively. Not all of patients with MCI develop to Alzheimer's disease, the reversion of patients with MCI to normal cognition exists. However, MCI is a significant risk factor. The ACR of older adults with normal cognition or MCI developed to dementia is 1-2%, and 5-15%, respectively; moreover, about half of patients with MCI developed to dementia in 5 years.
Cognitive training (CT) improves cognitive functions with repetitive practicing standardized cognitive tasks of specific cognitive functions, such as memory, attention, or problem solving. CT has widely defined including strategy training, in which contained cognitive exercise, strategy indicating and practicing to reducing cognitive impairments and improving performances. CT is more effective for MCI. Recently, computer-based CT (CCT) with many advantages gradually replaced the traditional paper-pencil form. Brief systematic review showed that the computer-based intervention had positive effects on behavioral symptoms, such as depression and anxiety, in patients with MCI and/or dementia. Previous studies demonstrated that computer-based intervention exhibited moderate treatment effects on overall cognitive functions in patients with MCI, and also had positive effects on learning, short-term memory, and behavioral symptoms.
Older people with cognitive impairments is expected to increase by global aging. It is important for improving or maintaining cognitive functions of older adults with MCI. The efficacy of the CCT on cognitive functions, neuropsychiatric symptoms, daily functions, and brain activated imaging of the magnetoencephalography (MEG) of in older adults with MCI is worth to explore for busy clinical practice.
Read the detailed description
The study design was a prospective and single-blinded randomized controlled trial. 36 participants with MCI were recruited and demographic data (age, gender, education level /years of education, marriage status etc.) were also collected. The MCI participants underwent the comprehensive review at baseline including neuropsychological assessment and Magnetic Resonance Imaging or Computerized Tomogram. Randomization treatment assignment will be generated by the random number table and assign the patient's intervention group accordingly. Sealed opaque envelopes containing the CCT group, or the dosage-matched control group sheets will be prepared and given to the therapists.
Based on the t-test effect size of index d 1.00 indicates, an estimated 17 participants in each group will be required for a power of 0.80 with a two-sided type I error of 0.05. Considering the 5% (q) drop rate, we will need to recruit 18 participants (N/1-q) for each group. The participants were randomly allocated to either the CCT group (18 participants) or the dosage-matched control group (18 participants) with individualized intervention for 30 minutes a day, 3 times a week for 4 consecutive weeks. Clinical outcome measures, and the imaging of the MEG were administered at pre- treatment, post-treatment and 1-month follow-up for further analysis.
Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 19.0. In statistical testing, two-sided p value ≤ 0.05 was considered statistically significant. The distributional properties of continuous variables were expressed by mean ± standard deviation (SD), categorical variables were presented by frequency and percentage. The differences in the distributions of continuous variables, categorical variables between the treatment and control groups were examined using two-sample t-test, Wilcoxon rank-sum test (or Mann-Whitney U test), and chi-square test. In addition, the minimum norm estimates (MNE), source-based time-frequency analysis, cross-frequency coupling, and functional connectivity were used to explore the differences of the activation of brain functions in participants between different treatment groups. The t-test was used to explore the differences of reaction time, rate of correction, and physical signals in stimulus reaction test of the MEG between in participants between different treatment groups. The correlation statistics was used to explore relationships between the scores of outcome measurements and the physical signals.
- Conditions
- Mild Cognitive Impairment
- Being tested
- computerized cognitive training, occupational therapy
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computerized cognitive trainingOther
participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.
occupational therapyOther
participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.
| Study group | Role | What they receive |
|---|---|---|
| computerized cognitive training | Experimental | participants will be trained by the "Cookies for the brainy day", including memory, attention, calculation, executive functions, and language training. Receives: Other: computerized cognitive training |
| occupational therapy | Active comparator | participants will receive craft activities of occupational therapy, such as weaving, origami etc. Receives: Other: occupational therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change scores of Quick Mild Cognitive Impairment screen
The Quick Mild Cognitive Impairment (Qmci) screen , a performance test, contains 6 subtests: Orientation, Registration, Clock Drawing, Delayed Recall, Verbal Fluency, and Logical Memory. The Qmci can be administered and scored in less than 5 min. The Qmci was validated with sound reliability and validity. The Qmci screen scores ranged from 0 to 100, with a higher score indicating greater cognitive function.
Measured: Baseline, 1 month, 2 months
Change scores of Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA), a performance test, is a standardized and validated tool designed to measure cognitive functions in visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The MoCA adds 1 score for those whose educational level ≤ 12 and scores ranged from 0 to 30, with a higher score indicating greater cognitive function.
Measured: Baseline, 1 month, 2 months
Secondary outcomes (9)
Change scores of Contextual Memory Test
The Contextual Memory Test is a standardized tool to measure the short-term and long-term retrospective memory and metacognition. The immediate and delayed memory is administrated by remembering 20 items related to daily context in 90 seconds. The scores of memory score, perceptual memory scores, and strategy-use scores were recorded.
Measured: Baseline, 1 month, 2 months
Change scores of Color Trail Test
The Color Trail Test has A, and B parts. Participants needs to orderly connect randomized arrangement numbers in part A, and orderly and alternately connect randomized arrangement numbers in different colors in part B. The finished time and amounts of hint, miss, color miss, and near miss were recorded.
Measured: Baseline, 1 month, 2 months
Change scores of Digits Span Tasks-forward and backward
The longest digits of forward and backward are 10 and 9, respectively. The total scores are 10 and 9, with a higher score indicating greater digit span memory.
Measured: Baseline, 1 month, 2 months
Change scores of Cancellation Test
The Cancellation Test presents 10 Arabic numerals (0-9) for 30 digits per row (8 rows) with 2 target numerals (2, 8) in 45 seconds. The amounts of correction and miss were recorded.
Measured: Baseline, 1 month, 2 months
Change scores of Pattern Comparison
The Pattern Comparisons presents 30 pairs of figures for distinguishing the same or not in 30 seconds. The amounts of correction, miss and total answers were recorded.
Measured: Baseline, 1 month, 2 months
Change scores of Everyday Memory Questionnaire
Everyday Memory Questionnaire is a self-rated memory function questionnaire to reflect the frequency of memory miss in daily life. The frequency of memory miss, such as less than 1 time in 1-month, 2-3 times in 1-month, 1 time in 1 week, 2-6 times in 1 week, and more than 1 time in 1 day, in each situation scores ranged from 0 to 4 in 13 situations.
Measured: Baseline, 1 month, 2 months
Change scores of Neuropsychiatric Inventory Questionnaire
The Neuropsychiatric Inventory Questionnaire (NPI-Q) measures symptoms severity and caregiver distress in 12 domains, such as apathy/indifference, appetite/eating problems, disinhibition, agitation/aggression, motor disturbance, anxiety, irritability, nighttime behaviors, depression/dysphoria, delusions, elation/euphoria, and hallucinations. The symptoms severity in each domain scores ranged from 1 to 3, with a higher score indicating more severe symptoms severity. In addition, the caregiver distress in each domain scores ranged from 0 to 5, with a higher score indicating more distress for caregiver.
Measured: Baseline, 1 month, 2 months
Change scores of Brief University of California San Diego (UCSD) Performance-based Skills Assessment
The Brief University of California San Diego (UCSD) Performance-based Skills Assessment (UPSA-B) contains 2 aspects: financial skills, and communication skills. The UPSA-B can be administered and scored in 10-15 min and used to measure participants how to administrate daily activities and do it how well. The UPSA-B scores ranged from 0 to 100, with a higher score indicating greater daily function.
Measured: Baseline, 1 month, 2 months
Change scores of Disability Assessment for Dementia Questionnaire (DAD)
The DAD contains 11 items of 3 domains: basic activity of daily living (dressing, hygiene, continence, eating), instrumental activity of daily living (meal preparation, telephoning, going on an outing, finance and correspondence, medications, and housework), and leisure activity (leisure). The scoring divides into 3 parts to measure about the initiation, planning and organization, and effective performance, and the scores of each part transforms to percentage for calculation. The higher percentage of each part indicates the less impairment in activities of daily living.
Measured: Baseline, 1 month, 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2018
- Study start13 Jul 2018
- Primary completion13 Feb 2019
- Study completion11 Mar 2019
Why it stopped: This study was stopped due to time and budgetary constraints.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei Hospital, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-ying Chang, Taipei Hospital, Taiwan
- Investigators
- Wan-ying Chang, MS, Principal investigator, Division of Occupational Therapy,Taipei Hospital, Ministry of Health and Welfare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03577717
- Sponsor's protocol ID
- 201804
- Status last verified
- Feb 2020
- First submitted
- 4 Jun 2018
- Last updated
- 17 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data are available from the Institutional Review Board of the Taipei Hospital, Ministry of Health and Welfare for researchers who meet the criteria for access to confidential data.
Publications
Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
PubMed 21514249Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for persons with mild to moderate dementia of the Alzheimer's or vascular type: a review. Alzheimers Res Ther. 2013 Aug 7;5(4):35. doi: 10.1186/alzrt189. eCollection 2013.
PubMed 23924584Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.
PubMed 19812460Bruscoli M, Lovestone S. Is MCI really just early dementia? A systematic review of conversion studies. Int Psychogeriatr. 2004 Jun;16(2):129-40. doi: 10.1017/s1041610204000092.
PubMed 15318760Caviness JN, Driver-Dunckley E, Connor DJ, Sabbagh MN, Hentz JG, Noble B, Evidente VG, Shill HA, Adler CH. Defining mild cognitive impairment in Parkinson's disease. Mov Disord. 2007 Jul 15;22(9):1272-7. doi: 10.1002/mds.21453.
PubMed 17415797Chen Y, Denny KG, Harvey D, Farias ST, Mungas D, DeCarli C, Beckett L. Progression from normal cognition to mild cognitive impairment in a diverse clinic-based and community-based elderly cohort. Alzheimers Dement. 2017 Apr;13(4):399-405. doi: 10.1016/j.jalz.2016.07.151. Epub 2016 Aug 30.
PubMed 27590706Cheng CH, Baillet S, Hsiao FJ, Lin YY. Effects of aging on neuromagnetic mismatch responses to pitch changes. Neurosci Lett. 2013 Jun 7;544:20-4. doi: 10.1016/j.neulet.2013.02.063. Epub 2013 Apr 2.
PubMed 23562510Cheng CH, Baillet S, Hsiao FJ, Lin YY. Effects of aging on the neuromagnetic mismatch detection to speech sounds. Biol Psychol. 2015 Jan;104:48-55. doi: 10.1016/j.biopsycho.2014.11.003. Epub 2014 Nov 15.
PubMed 25451380Cheng CH, Baillet S, Lin YY. Region-specific reduction of auditory sensory gating in older adults. Brain Cogn. 2015 Dec;101:64-72. doi: 10.1016/j.bandc.2015.10.004. Epub 2015 Oct 24.
PubMed 26507900Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. doi: 10.1097/00002093-200101000-00001.
PubMed 11236819De Vreese LP, Neri M, Fioravanti M, Belloi L, Zanetti O. Memory rehabilitation in Alzheimer's disease: a review of progress. Int J Geriatr Psychiatry. 2001 Aug;16(8):794-809. doi: 10.1002/gps.428.
PubMed 11536347Gaitan A, Garolera M, Cerulla N, Chico G, Rodriguez-Querol M, Canela-Soler J. Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Int J Geriatr Psychiatry. 2013 Jan;28(1):91-9. doi: 10.1002/gps.3794. Epub 2012 Apr 3.
PubMed 22473855Galante E, Venturini G, Fiaccadori C. Computer-based cognitive intervention for dementia: preliminary results of a randomized clinical trial. G Ital Med Lav Ergon. 2007 Jul-Sep;29(3 Suppl B):B26-32.
PubMed 18575355Gauthier S, Reisberg B, Zaudig M, Petersen RC, Ritchie K, Broich K, Belleville S, Brodaty H, Bennett D, Chertkow H, Cummings JL, de Leon M, Feldman H, Ganguli M, Hampel H, Scheltens P, Tierney MC, Whitehouse P, Winblad B; International Psychogeriatric Association Expert Conference on mild cognitive impairment. Mild cognitive impairment. Lancet. 2006 Apr 15;367(9518):1262-70. doi: 10.1016/S0140-6736(06)68542-5.
PubMed 16631882Garcia-Casal JA, Loizeau A, Csipke E, Franco-Martin M, Perea-Bartolome MV, Orrell M. Computer-based cognitive interventions for people living with dementia: a systematic literature review and meta-analysis. Aging Ment Health. 2017 May;21(5):454-467. doi: 10.1080/13607863.2015.1132677. Epub 2016 Jan 25.
PubMed 26806365
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Computerized Cognitive Training in the Elderly With Mild Cognitive Impairment: Clinical Outcomes and Magnetoencephalographic Imaging
- ClinicalTrials.gov ID
- NCT03577717
- Acronym / sponsor ID
- 201804
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was stopped due to time and budgetary constraints.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Taipei Hospital, TaiwanUniversity, hospital or other
- Study start
- 13 Jul 2018 (actual)
- Primary completion
- 13 Feb 2019 (actual)
- Study completion
- 11 Mar 2019 (actual)
- First posted
- 5 Jul 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.
Mild cognitive impairment (MCI) is the prodrome of the cognitive function declining before Alzheimer's disease or other dementia showed up, the impairments of language, visuospatial relationship, attention, and memory included and instrumental activities of daily living (IADL) influenced. MCI is considered as a transitional stage between normal aging and mild dementia, and the patients with MCI has differently fluctuated cognitive functions in a period of time, such as from normal cognition to MCI or developing to dementia. The annual conversion rate (ACR) of older adults with normal cognition developed to MCI is 30%, and 5% in clinical setting, and community, respectively. Not all of patients with MCI develop to Alzheimer's disease, the reversion of patients with MCI to normal cognition exists. However, MCI is a significant risk factor. The ACR of older adults with normal cognition or MCI developed to dementia is 1-2%, and 5-15%, respectively; moreover, about half of patients with MCI developed to dementia in 5 years.
Cognitive training (CT) improves cognitive functions with repetitive practicing standardized cognitive tasks of specific cognitive functions, such as memory, attention, or problem solving. CT has widely defined including strategy training, in which contained cognitive exercise, strategy indicating and practicing to reducing cognitive impairments and improving performances. CT is more effective for MCI. Recently, computer-based CT (CCT) with many advantages gradually replaced the traditional paper-pencil form. Brief systematic review showed that the computer-based intervention had positive effects on behavioral symptoms, such as depression and anxiety, in patients with MCI and/or dementia. Previous studies demonstrated that computer-based intervention exhibited moderate treatment effects on overall cognitive functions in patients with MCI, and also had positive effects on learning, short-term memory, and behavioral symptoms.
Older people with cognitive impairments is expected to increase by global aging. It is important for improving or maintaining cognitive functions of older adults with MCI. The efficacy of the CCT on cognitive functions, neuropsychiatric symptoms, daily functions, and brain activated imaging of the magnetoencephalography (MEG) of in older adults with MCI is worth to explore for busy clinical practice.
Detailed description
The study design was a prospective and single-blinded randomized controlled trial. 36 participants with MCI were recruited and demographic data (age, gender, education level /years of education, marriage status etc.) were also collected. The MCI participants underwent the comprehensive review at baseline including neuropsychological assessment and Magnetic Resonance Imaging or Computerized Tomogram. Randomization treatment assignment will be generated by the random number table and assign the patient's intervention group accordingly. Sealed opaque envelopes containing the CCT group, or the dosage-matched control group sheets will be prepared and given to the therapists.
Based on the t-test effect size of index d 1.00 indicates, an estimated 17 participants in each group will be required for a power of 0.80 with a two-sided type I error of 0.05. Considering the 5% (q) drop rate, we will need to recruit 18 participants (N/1-q) for each group. The participants were randomly allocated to either the CCT group (18 participants) or the dosage-matched control group (18 participants) with individualized intervention for 30 minutes a day, 3 times a week for 4 consecutive weeks. Clinical outcome measures, and the imaging of the MEG were administered at pre- treatment, post-treatment and 1-month follow-up for further analysis.
Statistical analysis was performed using Statistical Package for the Social Sciences (SPSS) version 19.0. In statistical testing, two-sided p value ≤ 0.05 was considered statistically significant. The distributional properties of continuous variables were expressed by mean ± standard deviation (SD), categorical variables were presented by frequency and percentage. The differences in the distributions of continuous variables, categorical variables between the treatment and control groups were examined using two-sample t-test, Wilcoxon rank-sum test (or Mann-Whitney U test), and chi-square test. In addition, the minimum norm estimates (MNE), source-based time-frequency analysis, cross-frequency coupling, and functional connectivity were used to explore the differences of the activation of brain functions in participants between different treatment groups. The t-test was used to explore the differences of reaction time, rate of correction, and physical signals in stimulus reaction test of the MEG between in participants between different treatment groups. The correlation statistics was used to explore relationships between the scores of outcome measurements and the physical signals.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| computerized cognitive training | Experimental | Other: computerized cognitive trainingparticipants will be trained by the "Cookies for the brainy day", including memory, attention, calculation, executive functions, and language training. |
| occupational therapy | Active comparator | Other: occupational therapyparticipants will receive craft activities of occupational therapy, such as weaving, origami etc. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- (1) were aged ≥65 years
- (2) amnestic type MCI was made using National Institute on Aging-Alzheimer's Association workgroups diagnostic guidelines for Alzheimer's disease with the clinical dementia rating scale (CDR) global scores of 0.5
- (3) could follow command, understand the content of the assessments, and cooperate with treatment interventions through verbal communication
Key exclusion criteria (6 listed)
- (1) had the score of Geriatric Depression Scale-Short Form (GDS-SF) > 7, indicating depression status
- (2) had the score of Barthel Index (BI)≠100, indicating dependent basic daily living of activities
- (3) were diagnosed with other MCI subtypes, including frontotemporal dementia or Lewy Body those present typically different MCI syndromes
- (4) had other neuropsychotic diseases
- (5) could not administrate with MEG
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 |
|---|---|---|
| computerized cognitive trainingparticipants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks. | Other | computerized cognitive training |
| occupational therapyparticipants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks. | Other | occupational therapy |
Primary outcome
Change scores of Quick Mild Cognitive Impairment screen
Time frame: Baseline, 1 month, 2 months
The Quick Mild Cognitive Impairment (Qmci) screen , a performance test, contains 6 subtests: Orientation, Registration, Clock Drawing, Delayed Recall, Verbal Fluency, and Logical Memory. The Qmci can be administered and scored in less than 5 min. The Qmci was validated with sound reliability and validity. The Qmci screen scores ranged from 0 to 100, with a higher score indicating greater cognitive function.
Change scores of Montreal Cognitive Assessment
Time frame: Baseline, 1 month, 2 months
The Montreal Cognitive Assessment (MoCA), a performance test, is a standardized and validated tool designed to measure cognitive functions in visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The MoCA adds 1 score for those whose educational level ≤ 12 and scores ranged from 0 to 30, with a higher score indicating greater cognitive function.
9 secondary outcomes
Change scores of Contextual Memory Test
Time frame: Baseline, 1 month, 2 months
Change scores of Color Trail Test
Time frame: Baseline, 1 month, 2 months
Change scores of Digits Span Tasks-forward and backward
Time frame: Baseline, 1 month, 2 months
Change scores of Cancellation Test
Time frame: Baseline, 1 month, 2 months
Change scores of Pattern Comparison
Time frame: Baseline, 1 month, 2 months
Change scores of Everyday Memory Questionnaire
Time frame: Baseline, 1 month, 2 months
Change scores of Neuropsychiatric Inventory Questionnaire
Time frame: Baseline, 1 month, 2 months
Change scores of Brief University of California San Diego (UCSD) Performance-based Skills Assessment
Time frame: Baseline, 1 month, 2 months
Change scores of Disability Assessment for Dementia Questionnaire (DAD)
Time frame: Baseline, 1 month, 2 months
Results and safety
The study was stopped early (reason given: This study was stopped due to time and budgetary constraints.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2020.
- Background: PubMed 21514249Albert MS, DeKosky ST, Dickson D, Dubois B, Feldman HH, Fox NC, Gamst A, Holtzman DM, Jagust WJ, Petersen RC, Snyder PJ, Carrillo MC, Thies B, Phelps CH. The diagnosis of mild cognitive impairment due to Alzheimer's disease: recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimers Dement. 2011 May;7(3):270-9. doi: 10.1016/j.jalz.2011.03.008. Epub 2011 Apr 21.
- Background: PubMed 23924584Bahar-Fuchs A, Clare L, Woods B. Cognitive training and cognitive rehabilitation for persons with mild to moderate dementia of the Alzheimer's or vascular type: a review. Alzheimers Res Ther. 2013 Aug 7;5(4):35. doi: 10.1186/alzrt189. eCollection 2013.
- Background: PubMed 19812460Barnes DE, Yaffe K, Belfor N, Jagust WJ, DeCarli C, Reed BR, Kramer JH. Computer-based cognitive training for mild cognitive impairment: results from a pilot randomized, controlled trial. Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):205-10. doi: 10.1097/WAD.0b013e31819c6137.
- Background: PubMed 15318760Bruscoli M, Lovestone S. Is MCI really just early dementia? A systematic review of conversion studies. Int Psychogeriatr. 2004 Jun;16(2):129-40. doi: 10.1017/s1041610204000092.
- Background: PubMed 17415797Caviness JN, Driver-Dunckley E, Connor DJ, Sabbagh MN, Hentz JG, Noble B, Evidente VG, Shill HA, Adler CH. Defining mild cognitive impairment in Parkinson's disease. Mov Disord. 2007 Jul 15;22(9):1272-7. doi: 10.1002/mds.21453.
- Background: PubMed 27590706Chen Y, Denny KG, Harvey D, Farias ST, Mungas D, DeCarli C, Beckett L. Progression from normal cognition to mild cognitive impairment in a diverse clinic-based and community-based elderly cohort. Alzheimers Dement. 2017 Apr;13(4):399-405. doi: 10.1016/j.jalz.2016.07.151. Epub 2016 Aug 30.
- Background: PubMed 23562510Cheng CH, Baillet S, Hsiao FJ, Lin YY. Effects of aging on neuromagnetic mismatch responses to pitch changes. Neurosci Lett. 2013 Jun 7;544:20-4. doi: 10.1016/j.neulet.2013.02.063. Epub 2013 Apr 2.
- Background: PubMed 25451380Cheng CH, Baillet S, Hsiao FJ, Lin YY. Effects of aging on the neuromagnetic mismatch detection to speech sounds. Biol Psychol. 2015 Jan;104:48-55. doi: 10.1016/j.biopsycho.2014.11.003. Epub 2014 Nov 15.
- Background: PubMed 26507900Cheng CH, Baillet S, Lin YY. Region-specific reduction of auditory sensory gating in older adults. Brain Cogn. 2015 Dec;101:64-72. doi: 10.1016/j.bandc.2015.10.004. Epub 2015 Oct 24.
- Background: PubMed 11236819Davis RN, Massman PJ, Doody RS. Cognitive intervention in Alzheimer disease: a randomized placebo-controlled study. Alzheimer Dis Assoc Disord. 2001 Jan-Mar;15(1):1-9. doi: 10.1097/00002093-200101000-00001.
- Background: PubMed 11536347De Vreese LP, Neri M, Fioravanti M, Belloi L, Zanetti O. Memory rehabilitation in Alzheimer's disease: a review of progress. Int J Geriatr Psychiatry. 2001 Aug;16(8):794-809. doi: 10.1002/gps.428.
- Background: PubMed 22473855Gaitan A, Garolera M, Cerulla N, Chico G, Rodriguez-Querol M, Canela-Soler J. Efficacy of an adjunctive computer-based cognitive training program in amnestic mild cognitive impairment and Alzheimer's disease: a single-blind, randomized clinical trial. Int J Geriatr Psychiatry. 2013 Jan;28(1):91-9. doi: 10.1002/gps.3794. Epub 2012 Apr 3.
- Individual participant dataSharing planned: No. Data are available from the Institutional Review Board of the Taipei Hospital, Ministry of Health and Welfare for researchers who meet the criteria for access to confidential data.
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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.
Wan-ying Chang, MS principal investigator
Division of Occupational Therapy,Taipei Hospital, Ministry of Health and Welfare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing computerized cognitive training and occupational therapy in people with Mild Cognitive Impairment, run by Taipei Hospital, Taiwan 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 3 inclusion and 6 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: stopped early, as of the sponsor's last update on 17 Feb 2020. 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 was stopped early (reason given: This study was stopped due to time and budgetary constraints.). 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?
Change scores of Quick Mild Cognitive Impairment screen (time frame: Baseline, 1 month, 2 months). 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 NCT03577717, which also lists 56 linked publications.
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 17 Feb 2020.