Mild Cognitive ImpairmentNCT06094452
Effects of 24-week Computerized Cognitive Training in Patients With MCI and AD
A study testing Computerized Cognitive Training and Treatment As Usual in people with Mild Cognitive Impairment and Alzheimer Disease, run by Chongqing Medical University at 1 site in China.
Trial summary
This study aims to testify multi-domain effects of computerized cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease through multi-dimensional evaluation. Read more about this study
- Who is it for?
- Ages 55 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease
- What is being tested?
- Computerized Cognitive Training and Treatment As Usual
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteChina
- Study dates
- 21 Oct 2020to 19 Aug 2022
- 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 55 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- between 55 and 90 years of age;
- a Clinical Dementia Rating (CDR) score of 0.5 or 1;
- at least three months of stable doses if receiving antidementia medication or mood-stabilizing medication for mild AD participants;
- primary school education and above;
- accompanied by a consistent caregiver (at least 5 days/week);
- informed consent.
Who cannot join
- factors that might preclude completion of assessments;
- severe psychiatric illness and the use of antidepressants;
- any condition that would preclude completion of training and follow-up tests;
- other disorders that would affect cognition.
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400016
About this study
Official title: Effects of 24-week Computerized Cognitive Training on Microbiota-gut-brain Axis in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease: a Randomized Controlled Trial
This study aims to testify multi-domain effects of computerized cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease through multi-dimensional evaluation.
Read the detailed description
This study aimed to elucidate the neural process enhancement and remodulation in gut microbes resulting from older adults with MCI and mild AD in a randomized controlled trial of a 24-week computerized cognitive training (CCT) program.
After recruitment and baseline assessments, pairs of participants with MCI and mild AD would be randomly allocated into the corresponding subgroup. Participants in CCT group will receive a computerized multidomain cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Adherence to the intervention will be supervised by an independent researcher. The number of training days and training hours per day will be recorded. Patients in control group received treatment as usual (TAU) for 24 weeks. The neuropsychological measures will be performed at baseline, follow-up at 4 weeks, 12 weeks, and 24 weeks; functional Near-Infrared Spectroscopy (fNIRS) data and fecal samples will collected at baseline and 24 weeks.
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Being tested
- Computerized Cognitive Training, Treatment As Usual
- Keywords
- computerized cognitive training, functional near-infrared spectroscopy, mild cognitive impairment, Alzheimer's disease, brain-gut-microbiota axis, gut microbiota
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computerized Cognitive TrainingOther
Participants in intervention group will receive a multidomain, adaptive computerized cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Multidomain coverage paradigms include working memory, calculation, processing speed, attention, executive function, and short-term and long-term memory.
Treatment As UsualOther
Patients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet .
| Study group | Role | What they receive |
|---|---|---|
| Computerized Cognitive Training | Experimental | Adaptive computerized cognitive training program (www.66nao.com) and the intensity is at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Receives: Other: Computerized Cognitive Training |
| Treatment As Usual | Active comparator | Patients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet. Receives: Other: Treatment As Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Global Cognition
The Alzheimer's Disease Assessment Scale- cognitive subscale (11 items) will be used to evaluate global cognition and served as the primary outcome measure. The minimum and maximum values are 0 and 70 respectively, and higher scores mean a worse outcome.
Measured: baseline, 4, 12, 24 weeks
Secondary outcomes (15)
Learning
The Auditory Verbal Learning Test (minimum to maximum: 0-45) will be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Episodic Memory
The Free and Cued Selective Reminding Test (minimum to maximum: 0-48) will be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Attention
The Trail Making Test (minimum to maximum: 0-24) will be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Executive Function
The Digital Span Test (minimum to maximum: 0-10) will also be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Visuospatial Function
The Clock Drawing Test (minimum to maximum: 0-15) will be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Verbal Ability
The Boston Naming Test (minimum to maximum: 0-30) will be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Verbal Frequency
The Verbal Frequency Test (minimum: 0, no maximum) will also be applied, and higher scores mean a better outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Neuropsychiatric Symptoms
The Neuropsychiatric Inventory (minimum to maximum: 0-144) will be used, and higher scores mean a worse outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Depression
The 30-Geriatric Depression Scale (minimum to maximum: 0-30) will be used, and higher scores mean a worse outcome for the scale.
Measured: baseline, 4, 12, 24 weeks
Daily Living Function
The Instrumental Activities of Daily Living scale (minimum to maximum: 0-31) will be used, and higher scores mean a worse outcome for this scale.
Measured: baseline, 4, 12, 24 weeks
Severity of Cognitive Impairment
The Clinical Dementia Rating scale (sum of boxes, minimum to maximum: 0-18) will be used, and higher scores mean a worse outcome for this scale.
Measured: baseline, 4, 12, 24 weeks
Brain Functional Connectivity
The regions of interests (ROIs) are selected as the Brodmann Area (BA) 9 and 46 (overlapping the dorsolateral prefrontal cortex, DLPFC), left Brodmann Area 6 (overlapping pre-Motor and Supplementary Motor Cortex, PM-SMC), and right Brodmann Area 45 (overlapping pars triangularis Broca's area). For each resting-state dataset of fNIRS, functional connectivity (FC) will be analyzed by Spearman's correlation between the time series of each ROI-to-ROI pair.
Measured: baseline and 24 weeks
Alpha-diversity of Gut Microbiome
Fecal samples will be collected from patients in standard 300 mL sterilin tubes and frozen immediately at -80°C. Patients will be asked to produce the first-morning sample for consistency and to avoid alcohol the previous 24 h. After 16S rRNA high-throughput sequencing, the diversity analysis of species under a sample (α-diversity) of the bacteria on Genus, will be analyzed in R.
Measured: baseline and 24 weeks
Beta-diversity of Gut Microbiome
After 16S rRNA high-throughput sequencing, the cluster analysis between different samples (β-diversity) will be analyzed in R.
Measured: baseline and 24 weeks
Composition of Gut Microbiome
After 16S rRNA high-throughput sequencing, the compositional analysis of bacteria on genus will be analyzed in R.
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2023
- Study start21 Oct 2020
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After recruitment and baseline assessments, pairs of participants with MCI and mild AD will be randomly allocated into either the CCT group and the control group. Participants in CCT group will receive a multidomain adaptive computerized cognitive training program (www.66nao.com) for 24 weeks. Patients in control group will receive treatment as usual (TAU) for 24 weeks.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chongqing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wenbo Zhang, Chongqing Medical University
- Investigators
- Weihua Yu, Dr., Principal investigator, Chongqing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06094452
- Sponsor's protocol ID
- ChongqingMU9
- Status last verified
- Oct 2023
- First submitted
- 4 Oct 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: With publication of research articles, de-identified data collected for the study, including individual participant data, can be made available to interested parties on reasonable request, and if in line with privacy regulations. Data can be requested at least 18 months after publication of the research articles, with a proposal by sending an e-mail to Dr. Yang Lü.
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of 24-week Computerized Cognitive Training on Microbiota-gut-brain Axis in Patients With Mild Cognitive Impairment and Mild Alzheimer's Disease: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06094452
- Acronym / sponsor ID
- ChongqingMU9
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease
- Keywords
- computerized cognitive training, functional near-infrared spectroscopy, mild cognitive impairment, Alzheimer's disease, brain-gut-microbiota axis, gut microbiota
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Chongqing Medical UniversityUniversity, hospital or other
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 23 Oct 2023 (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 aims to testify multi-domain effects of computerized cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease through multi-dimensional evaluation.
Detailed description
This study aimed to elucidate the neural process enhancement and remodulation in gut microbes resulting from older adults with MCI and mild AD in a randomized controlled trial of a 24-week computerized cognitive training (CCT) program.
After recruitment and baseline assessments, pairs of participants with MCI and mild AD would be randomly allocated into the corresponding subgroup. Participants in CCT group will receive a computerized multidomain cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Adherence to the intervention will be supervised by an independent researcher. The number of training days and training hours per day will be recorded. Patients in control group received treatment as usual (TAU) for 24 weeks. The neuropsychological measures will be performed at baseline, follow-up at 4 weeks, 12 weeks, and 24 weeks; functional Near-Infrared Spectroscopy (fNIRS) data and fecal samples will collected at baseline and 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- After recruitment and baseline assessments, pairs of participants with MCI and mild AD will be randomly allocated into either the CCT group and the control group. Participants in CCT group will receive a multidomain adaptive computerized cognitive training program (www.66nao.com) for 24 weeks. Patients in control group will receive treatment as usual (TAU) for 24 weeks.
| Arm | Type | Receives |
|---|---|---|
| Computerized Cognitive Training | Experimental | Other: Computerized Cognitive TrainingAdaptive computerized cognitive training program (www.66nao.com) and the intensity is at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. |
| Treatment As Usual | Active comparator | Other: Treatment As UsualPatients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet. |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- between 55 and 90 years of age;
- a Clinical Dementia Rating (CDR) score of 0.5 or 1;
- at least three months of stable doses if receiving antidementia medication or mood-stabilizing medication for mild AD participants;
- primary school education and above;
- accompanied by a consistent caregiver (at least 5 days/week);
Key exclusion criteria (4 listed)
- factors that might preclude completion of assessments;
- severe psychiatric illness and the use of antidepressants;
- any condition that would preclude completion of training and follow-up tests;
- other disorders that would affect cognition.
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 in intervention group will receive a multidomain, adaptive computerized cognitive training program (www.66nao.com) and will be required to complete at least 30 minutes of training per day (3 cycle of 5 2-min tasks), 5 days a week for 24 weeks. Multidomain coverage paradigms include working memory, calculation, processing speed, attention, executive function, and short-term and long-term memory. | Other | Computerized Cognitive Training |
| Treatment As UsualPatients in control group will receive TAU for 24 weeks, which includes (1) regular medication management from the Memory Clinic, if applicable; (2) basic health education at each follow-up (face to face) and twice per month on the internet . | Other | Treatment As Usual |
Primary outcome
Global Cognition
Time frame: baseline, 4, 12, 24 weeks
The Alzheimer's Disease Assessment Scale- cognitive subscale (11 items) will be used to evaluate global cognition and served as the primary outcome measure. The minimum and maximum values are 0 and 70 respectively, and higher scores mean a worse outcome.
15 secondary outcomes
Learning
Time frame: baseline, 4, 12, 24 weeks
Episodic Memory
Time frame: baseline, 4, 12, 24 weeks
Attention
Time frame: baseline, 4, 12, 24 weeks
Executive Function
Time frame: baseline, 4, 12, 24 weeks
Visuospatial Function
Time frame: baseline, 4, 12, 24 weeks
Verbal Ability
Time frame: baseline, 4, 12, 24 weeks
Verbal Frequency
Time frame: baseline, 4, 12, 24 weeks
Neuropsychiatric Symptoms
Time frame: baseline, 4, 12, 24 weeks
Depression
Time frame: baseline, 4, 12, 24 weeks
Daily Living Function
Time frame: baseline, 4, 12, 24 weeks
Severity of Cognitive Impairment
Time frame: baseline, 4, 12, 24 weeks
Brain Functional Connectivity
Time frame: baseline and 24 weeks
Alpha-diversity of Gut Microbiome
Time frame: baseline and 24 weeks
Beta-diversity of Gut Microbiome
Time frame: baseline and 24 weeks
Composition of Gut Microbiome
Time frame: baseline and 24 weeks
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 23 Oct 2023.
- The trail has also been registered under chictr.org.cn (ChiCTR2100051362).Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. With publication of research articles, de-identified data collected for the study, including individual participant data, can be made available to interested parties on reasonable request, and if in line with privacy regulations. Data can be requested at least 18 months after publication of the research articles, with a proposal by sending an e-mail to Dr. Yang Lü.
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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.
Weihua Yu, Dr. principal investigator
Chongqing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computerized Cognitive Training and Treatment As Usual in people with Mild Cognitive Impairment and Alzheimer Disease, run by Chongqing Medical University at 1 site in China.
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 4 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 23 Oct 2023. 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 China. 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?
Global Cognition (time frame: baseline, 4, 12, 24 weeks). 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 23 Oct 2023.