Amnestic Mild Cognitive ImpairmentNCT04063956
COG-REAGENT: COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT
A study testing multi-domain internet-based adaptive training program in people with Amnestic Mild Cognitive Impairment, run by Xuanwu Hospital, Beijing at 1 site in China.
Trial summary
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with amnestic mild cognitive impairment (aMCI). Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- What is being tested?
- multi-domain internet-based adaptive training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteChina
- Study dates
- 6 Nov 2019to Dec 2023
- 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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate Han Chinese, 50-85 years of age with a caregiver that accompanies the subject consistently at least 4 days a week;
- Complaint and/or informant report of a cognitive impairment lasting for at least 3 months;
- Clinical diagnosis of MCI according to the MCI core clinical criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
- A prominent manifestation of memory deficit with or without other cognitive domain impairments;
- Mini-Mental State Examination (MMSE) score ≥24, and Clinical dementia rating (CDR) = 0.5, and
- Normal or slightly impaired activities of daily living as defined by a total score of ≤ 1.5 on the three functional CDR domains (home and hobbies, community affairs, and personal care).
Who cannot join
- Severe aphasia, physical disabilities, or any other disease that may preclude completion of neuropsychological testing;
- A medical history of stroke with focal neurological features including hemiparesis, sensory loss, visual field deficits, and evidence of responsible lesions on MRI;
- Significant white matter lesions (Fazekas score = 3-6);
- Disorders other than aMCI that may affect cognition;
- Depression or other psychiatric disorders;
- Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, drug addiction;
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- Use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
- Inability to undergo a brain MRI; and
- Other conditions that in the investigator's opinion might not be suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xuanwu Hospital, Capital Medical University
Beijing, 100053
Yi Tang, M.D., Ph.D., 008613811021432, tangyixw@vip.163.com
Yi Xing, M.D., 008613269627589, xingyi_211@163.com
About this study
Official title: The Efficacy of COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT (COG-REAGENT): a Multi-center Randomized Controlled Trial
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with amnestic mild cognitive impairment (aMCI). Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.
Read the detailed description
Background: Alzheimer's disease (AD) is the most common dementia and the major cause for senile dementia. With the increase of life expectancy, AD has become a global problem. However, to date, drug therapies only have modest benefits for patients with AD. Recently, researchers have begun to focus on early intervention of AD at its preclinical stages. Individuals with amnestic mild cognitive impairment (aMCI), often the prodromal stage of AD, report mild short-term memory difficulties but preserved independence in activities of daily living. The aMCI stage is important to slow or even prevent the development of AD. Some previous studies have suggested cognitive training is a potential non-pharmacological intervention for aMCI, however, the results were inconsistent. Thus, investigators will conduct this multi-center randomized controlled trial to explore whether and how cognitive training improves cognitive function in patients with aMCI.
Objectives: The first aim of this multi-center single-blinded, randomized controlled trial is to assess whether internet-based cognitive training improves cognitive abilities in patients with aMCI. Furthermore, the second objective is to evaluate the effect of cognitive training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI.
Patients and Methods: The study will include 260 patients diagnosed with aMCI from eight centers around China. The patients will be randomized to either a cognitive training group or an active-control group. The intervention is 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week. Within each task, high accuracy (80%) is required to upgrade to the next difficulty level. The active- control group will receive five processing speed and attention tasks, whose duration also total to 40 min each training day. However, these tasks are set to a fixed, primary difficulty level across the study.
Neuropsychological assessments and structural and functional magnetic resonance imaging (MRI) will be performed at the baseline, end of intervention, and 6 months after randomization to measure long-term resilience of the effect.
Relevance: Early intervention of aMCI has the potential to delay or even prevent the development of dementia. Some previous studies have suggested cognitive training is a potential non-pharmacological intervention for aMCI, however, the results were inconsistent. Thus, the proposed study is to determine the efficacy of cognitive training in patients with aMCI. Secondly, using functional and structural MRI, this study is to reveal the potential mechanisms underlying cognitive training.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- multi-domain internet-based adaptive training program, active-control program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
multi-domain internet-based adaptive training programBehavioural
The training paradigms include a time perception task, visual search task, rapid serial presentation task, delayed match to sample task, paired-associate recall task, attention span task, digit span task, go-no go task, Stroop task, task switching, auditory span task and n-back working memory task. Each task has several difficulty levels. The tasks are grouped in different cognitive domains including: processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning, and problem-solving. Participants in the cognitive training group will complete 40 min of training daily, 4 days a week for 12 weeks. When a high accuracy (80%) is achieved for each task, the level of difficulty will be upgraded for that task.
active-control programBehavioural
For the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive training group | Experimental | Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 4 x 40 minutes per week, for 12 weeks. Receives: Behavioral: multi-domain internet-based adaptive training program |
| Active-control group | Active comparator | Fixed, primary difficulty level tasks. 4 x 40 minutes per week, for 12 weeks. Receives: Behavioral: active-control program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention)
Secondary outcomes (14)
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
ADAS-cog 11 scale ranges from 0 to 70, and higher value represents a worse outcome. This study will use ADAS-cog to assess changes in the global cognitive function after intervention.
Measured: 12 weeks (end of intervention), 6 months
Change in brain volume and white matter integrity
Structural MRI will be used to measure brain volume and white matter integrity.
Measured: 12 weeks (end of intervention), 6 months
Change in brain connectivity
Functional MRI will be used to measure brain connectivity.
Measured: 12 weeks (end of intervention), 6 months
Change in Mini-mental State Examination
Mini-mental State Examination (MMSE) will be used to evaluate the general cognitive function. MMSE ranges from 0 to 30, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Montreal Cognitive Assessment
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
Measured: 6 months
Change in memory function
WHO-UCLA Auditory Verbal Learning Test will be used to assess memory function. It ranges from 0 to 45, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Digit span forward
Digit span will be used to assess attention. It ranges from 3 to 10, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Digit span backward
Digit span backward will be used to assess executive function. It ranges from 2 to 8, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Trail Making Test
Trail-Making Test B minus A score will be used to assess executive function. Trail-Making Test B minus A ranges from -150 to 300, higher value represents a worse outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Boston Naming Test
Boston Naming Test will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Activities of Daily Living
Activities of Daily Living (ADL) scale will be used to assess the change of life quality. It ranges from 20 to 80. The "20" represents normal life ability and the higher score presents the worse life ability.
Measured: 12 weeks (end of intervention), 6 months
Change in Clinical Dementia Rating Scale sum of the boxes
Clinical Dementia Rating Scale sum of the boxes (CDR-SB) will be used to evaluate the general cognitive function. CDR-SB ranges from 0 to 18, and higher value represents a worse outcome.
Measured: 12 weeks (end of intervention), 6 months
Change in Quality of Life-Alzheimer's Disease (QoL-AD) Scale
Quality of Life-Alzheimer's Disease (QoL-AD) Scale will be used to evaluate the life quality of the patients. The total score is 13-52, with higher scores indicating better QoL.
Measured: 12 weeks (end of intervention), 6 months
Change in Cookie Theft picture description task
Cookie Theft picture description task will be used to evaluate spontaneous discourse. We will analyze the total number of syllables produced, the total number of information units produced, and the total time taken to describe the picture
Measured: 12 weeks (end of intervention), 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2019
- Study start6 Nov 2019
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Amnestic Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Xuanwu Hospital, BeijingThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 260 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xuanwu Hospital, Beijing
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Shandong Provincial Hospital, First Affiliated Hospital of Zhejiang University, The First Hospital of Jilin University, Beijing Friendship Hospital, First Affiliated Hospital Xi'an Jiaotong University, Wuhan University
- Responsible party
- Sponsor
- Investigators
- Yi Tang, M.D., Ph.D., Principal investigator, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04063956
- Sponsor's protocol ID
- 2019042-XZ1
- Status last verified
- Jul 2022
- First submitted
- 19 Aug 2019
- Last updated
- 19 Jul 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Xing Y, Zhu Z, Du Y, Zhang J, Qu Q, Sun L, Li Y, Guo Y, Peng G, Liu Y, Yu Y, Qiao Y, Xie B, Shi X, Lu J, Jia J, Tang Y. The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial. J Alzheimers Dis. 2020;75(3):779-787. doi: 10.3233/JAD-191314.
PubMed 32333590
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT (COG-REAGENT): a Multi-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04063956
- Acronym / sponsor ID
- 2019042-XZ1
- Conditions
- Amnestic Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 260 participants (estimated)
- Lead sponsor
- Xuanwu Hospital, BeijingUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Shanxi Medical University, Shandong Provincial Hospital, First Affiliated Hospital of Zhejiang University, The First Hospital of Jilin University, Beijing Friendship Hospital, First Affiliated Hospital Xi'an Jiaotong University, Wuhan University
- Study start
- 6 Nov 2019 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 21 Aug 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.
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with amnestic mild cognitive impairment (aMCI). Half of participants will receive multi-domain adaptive internet-based training program, while the other half will receive a fixed, primary difficulty level task.
Detailed description
Background: Alzheimer's disease (AD) is the most common dementia and the major cause for senile dementia. With the increase of life expectancy, AD has become a global problem. However, to date, drug therapies only have modest benefits for patients with AD. Recently, researchers have begun to focus on early intervention of AD at its preclinical stages. Individuals with amnestic mild cognitive impairment (aMCI), often the prodromal stage of AD, report mild short-term memory difficulties but preserved independence in activities of daily living. The aMCI stage is important to slow or even prevent the development of AD. Some previous studies have suggested cognitive training is a potential non-pharmacological intervention for aMCI, however, the results were inconsistent. Thus, investigators will conduct this multi-center randomized controlled trial to explore whether and how cognitive training improves cognitive function in patients with aMCI.
Objectives: The first aim of this multi-center single-blinded, randomized controlled trial is to assess whether internet-based cognitive training improves cognitive abilities in patients with aMCI. Furthermore, the second objective is to evaluate the effect of cognitive training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI.
Patients and Methods: The study will include 260 patients diagnosed with aMCI from eight centers around China. The patients will be randomized to either a cognitive training group or an active-control group. The intervention is 12-week internet-based cognitive training performed for 40 minutes per day, 4 days a week. Within each task, high accuracy (80%) is required to upgrade to the next difficulty level. The active- control group will receive five processing speed and attention tasks, whose duration also total to 40 min each training day. However, these tasks are set to a fixed, primary difficulty level across the study.
Neuropsychological assessments and structural and functional magnetic resonance imaging (MRI) will be performed at the baseline, end of intervention, and 6 months after randomization to measure long-term resilience of the effect.
Relevance: Early intervention of aMCI has the potential to delay or even prevent the development of dementia. Some previous studies have suggested cognitive training is a potential non-pharmacological intervention for aMCI, however, the results were inconsistent. Thus, the proposed study is to determine the efficacy of cognitive training in patients with aMCI. Secondly, using functional and structural MRI, this study is to reveal the potential mechanisms underlying cognitive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive training group | Experimental | Behavioral: multi-domain internet-based adaptive training programMulti-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 4 x 40 minutes per week, for 12 weeks. |
| Active-control group | Active comparator | Behavioral: active-control programFixed, primary difficulty level tasks. 4 x 40 minutes per week, for 12 weeks. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Literate Han Chinese, 50-85 years of age with a caregiver that accompanies the subject consistently at least 4 days a week;
- Complaint and/or informant report of a cognitive impairment lasting for at least 3 months;
- Clinical diagnosis of MCI according to the MCI core clinical criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
- A prominent manifestation of memory deficit with or without other cognitive domain impairments;
- Mini-Mental State Examination (MMSE) score ≥24, and Clinical dementia rating (CDR) = 0.5, and
Key exclusion criteria (9 listed)
- Severe aphasia, physical disabilities, or any other disease that may preclude completion of neuropsychological testing;
- A medical history of stroke with focal neurological features including hemiparesis, sensory loss, visual field deficits, and evidence of responsible lesions on MRI;
- Significant white matter lesions (Fazekas score = 3-6);
- Disorders other than aMCI that may affect cognition;
- Depression or other psychiatric disorders;
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 internet-based adaptive training programThe training paradigms include a time perception task, visual search task, rapid serial presentation task, delayed match to sample task, paired-associate recall task, attention span task, digit span task, go-no go task, Stroop task, task switching, auditory span task and n-back working memory task. Each task has several difficulty levels. The tasks are grouped in different cognitive domains including: processing speed, attention, perception, long-term memory, working memory, calculation, executive control, reasoning, and problem-solving. Participants in the cognitive training group will complete 40 min of training daily, 4 days a week for 12 weeks. When a high accuracy (80%) is achieved for each task, the level of difficulty will be upgraded for that task. | Behavioural | Cognitive training group |
| active-control programFor the control group, tasks for processing speed and attention are included. Importantly, a fixed, primary difficulty level for all participants in the control group is set. | Behavioural | Active-control group |
Primary outcome
Change in Montreal Cognitive Assessment
Time frame: 12 weeks (end of intervention)
Montreal Cognitive Assessment (MoCA) will be used to evaluate the general cognitive function. MoCA ranges from 0 to 30, and higher value represents a better outcome.
14 secondary outcomes
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
Time frame: 12 weeks (end of intervention), 6 months
Change in brain volume and white matter integrity
Time frame: 12 weeks (end of intervention), 6 months
Change in brain connectivity
Time frame: 12 weeks (end of intervention), 6 months
Change in Mini-mental State Examination
Time frame: 12 weeks (end of intervention), 6 months
Change in Montreal Cognitive Assessment
Time frame: 6 months
Change in memory function
Time frame: 12 weeks (end of intervention), 6 months
Change in Digit span forward
Time frame: 12 weeks (end of intervention), 6 months
Change in Digit span backward
Time frame: 12 weeks (end of intervention), 6 months
Change in Trail Making Test
Time frame: 12 weeks (end of intervention), 6 months
Change in Boston Naming Test
Time frame: 12 weeks (end of intervention), 6 months
Change in Activities of Daily Living
Time frame: 12 weeks (end of intervention), 6 months
Change in Clinical Dementia Rating Scale sum of the boxes
Time frame: 12 weeks (end of intervention), 6 months
Change in Quality of Life-Alzheimer's Disease (QoL-AD) Scale
Time frame: 12 weeks (end of intervention), 6 months
Change in Cookie Theft picture description task
Time frame: 12 weeks (end of intervention), 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2023.
- Derived from this study: PubMed 32333590Xing Y, Zhu Z, Du Y, Zhang J, Qu Q, Sun L, Li Y, Guo Y, Peng G, Liu Y, Yu Y, Qiao Y, Xie B, Shi X, Lu J, Jia J, Tang Y. The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial. J Alzheimers Dis. 2020;75(3):779-787. doi: 10.3233/JAD-191314.
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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.
Yi Tang, M.D., Ph.D. principal investigator
Xuanwu Hospital, Beijing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-domain internet-based adaptive training program in people with Amnestic Mild Cognitive Impairment, run by Xuanwu Hospital, Beijing 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 9 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: status not confirmed, as of the sponsor's last update on 19 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yi Tang, M.D., Ph.D. (008613811021432, tangyixw@vip.163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (time frame: 12 weeks (end of intervention)). 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 NCT04063956, which also lists 1 linked publication.
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 19 Jul 2023.