Vascular Cognitive Impairment no DementiaCog-VACCINENCT02640716
Cog-VACCINE: Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
A study testing multi-domain internet-based adaptive training program in people with Vascular Cognitive Impairment no Dementia, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. 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 years and older
- Conditions the study is for
- Vascular Cognitive Impairment no Dementia
- What is being tested?
- multi-domain internet-based adaptive training program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate Han Chinese, aged 50-78 years, with a consistent caregiver who accompanies the subject at least 4 days a week;
- Complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 3 months;
- Neither normal nor demented according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a clinical dementia rating (CDR) ≥ 0.5 on at least one domain and global score ≤ 0.5; a Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above);
- 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).
- The MRI entry criteria are as follows:
- Multiple (≥ 3) supratentorial subcortical small infarcts (3-20 mm in diameter), with/without white matter lesions (WML) of any degree; or moderate to severe WML (score ≥ 2 according to the Fazekas rating scale) with/without small infarct;
- Absence of cortical and watershed infarcts, hemorrhages, hydrocephalus, and WMLs with specific causes (e.g., multiple sclerosis);
- No hippocampal or entorhinal cortex atrophy (score 0 according to the medial temporal lobe atrophy scale of Scheltens).
Who cannot join
- severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- disorders other than subcortical VCIND that may affect cognition;
- a Hamilton depression scale (HAMD) score >17 or schizophrenia;
- new strokes within 3 months before baseline;
- inherited or inflammatory small vessel disease;
- clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular system disease;
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- cancer, alcoholism, drug addiction;
- use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
- inability to undergo a brain MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
This study evaluates the efficacy and mechanism of internet-based cognitive training in patients with subcortical VCIND. 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:
Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes which fall short of a dementia diagnosis. Because of its high prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent years. Although it has been widely recognized that early intervention of VCIND holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive training significantly improved executive and other aspects of cognitive function in health older adults and patients with cognitive impairment. Whether and how cognitive training improves cognitive function in patients with VCIND remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive training in patients with subcortical VCIND improves their cognitive abilities. 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. Finally, possible genetic and plasma biomarkers related to a positive effect or lack of effect of the training will be examined.
Patients and Methods:
The proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients diagnosed with VCIND from the neurology clinics at Beijing Friendship hospital, Xuan Wu hospital, and geriatric clinic at Fu Xing hospital, Capital Medical University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 minutes over 35 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 7 weeks after training.
Relevance:
Currently there is no known treatment available for VCIND. The proposed study is to determine the efficacy of cognitive training in patients with VCIND. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive training.
- Being tested
- multi-domain internet-based adaptive training program, placebo 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 cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels.
placebo 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 |
|---|---|---|
| training group | Active comparator | Intervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. Receives: Behavioral: multi-domain internet-based adaptive training program |
| control group | Placebo comparator | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. Receives: Behavioral: placebo program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation.
The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.
Measured: Baseline and 7 weeks
Estimated Mean Change of the Trail Making Test (TMT) B-A
The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar
Measured: Baseline and 7 weeks
Secondary outcomes (3)
Estimated Mean Changes in Left Hippocampal Volume
The left hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean changes in left hippocampal volume from baseline at week 7 is reported.
Measured: Baseline and 7 weeks
Estimated Mean Change in Right Hippocampal Volume
The right hippocampal volume on structural Magnetic Resonance Imaging (MRI) was measured by voxel-based morphometrics. The estimated mean change in right hippocampal volume from baseline at week 7 is reported.
Measured: Baseline and 7 weeks
Estimated Mean Change in Brain White Matter Integrity
The white matter microstructure was measured by diffusion tensor imaging (DTI) . The whole-brain average fractional anisotropy (FA) was calculated to show brain white matter integrity. The change of whole-brain average FA from baseline at week 7 is reported.
Fractional anisotropy (FA) is a scalar value between zero and one that describes the degree of anisotropy of a diffusion process. A value of zero means that diffusion is isotropic, i.e. it is unrestricted (or equally restricted) in all directions.
Measured: Baseline and 7 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion8 May 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vascular Cognitive Impairment no DementiaStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Fu Xing Hospital, Capital Medical University
- Responsible party
- Principal investigator, Yi Tang, Beijing Friendship Hospital
- Investigators
- Yi Tang, M.D., Ph.D., Principal investigator, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02640716
- Sponsor's protocol ID
- 2015010
- Acronym
- Cog-VACCINE
- Status last verified
- Jul 2020
- First submitted
- 21 Dec 2015
- Last updated
- 23 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li QG, Xing Y, Zhu ZD, Fei XL, Tang Y, Lu J. Effects of computerized cognitive training on functional brain networks in patients with vascular cognitive impairment and no dementia. CNS Neurosci Ther. 2024 Jun;30(6):e14779. doi: 10.1111/cns.14779.
PubMed 38828650Tang Y, Zhu Z, Liu Q, Li F, Yang J, Li F, Xing Y, Jia J. The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial. Trials. 2016 Aug 5;17(1):392. doi: 10.1186/s13063-016-1523-x.
PubMed 27496126
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cog-VACCINE Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Training in Patients With Vascular Cognitive Impairment, no Dementia
- ClinicalTrials.gov ID
- NCT02640716
- Acronym / sponsor ID
- Cog-VACCINE / 2015010
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Collaborators
- Xuanwu Hospital, Beijing, Fu Xing Hospital, Capital Medical University
- Study start
- Oct 2015
- Primary completion
- 8 May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 29 Dec 2015 (estimated)
- Results
- Posted 23 Jul 2020
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 subcortical VCIND. 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:
Vascular cognitive impairment no dementia (VCIND) refers to cognitive deficits associated with underlying vascular causes which fall short of a dementia diagnosis. Because of its high prevalence and high progression to dementia, interest in VCIND has greatly expanded in recent years. Although it has been widely recognized that early intervention of VCIND holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Executive dysfunction is the characteristic impairment in subcortical VCIND, and cognitive training significantly improved executive and other aspects of cognitive function in health older adults and patients with cognitive impairment. Whether and how cognitive training improves cognitive function in patients with VCIND remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive training in patients with subcortical VCIND improves their cognitive abilities. 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. Finally, possible genetic and plasma biomarkers related to a positive effect or lack of effect of the training will be examined.
Patients and Methods:
The proposed study is a three-center, double-blinded, randomized controlled trial that will include 60 patients diagnosed with VCIND from the neurology clinics at Beijing Friendship hospital, Xuan Wu hospital, and geriatric clinic at Fu Xing hospital, Capital Medical University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive training performed for 30 minutes over 35 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 7 weeks after training.
Relevance:
Currently there is no known treatment available for VCIND. The proposed study is to determine the efficacy of cognitive training in patients with VCIND. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive training.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| training group | Active comparator | Behavioral: multi-domain internet-based adaptive training programIntervention: Multi-domain adaptive internet-based training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. 5 x 30 minutes per week, for 7 weeks. |
| control group | Placebo comparator | Behavioral: placebo programIntervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 7 weeks. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Literate Han Chinese, aged 50-78 years, with a consistent caregiver who accompanies the subject at least 4 days a week;
- Complaint and/or informant report of cognitive impairment involving memory and/or other cognitive domains lasting for at least 3 months;
- Neither normal nor demented according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, with a clinical dementia rating (CDR) ≥ 0.5 on at least one domain and global score ≤ 0.5; a Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above);
- 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).
- Multiple (≥ 3) supratentorial subcortical small infarcts (3-20 mm in diameter), with/without white matter lesions (WML) of any degree; or moderate to severe WML (score ≥ 2 according to the Fazekas rating scale) with/without small infarct;
Key exclusion criteria (9 listed)
- severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- disorders other than subcortical VCIND that may affect cognition;
- a Hamilton depression scale (HAMD) score >17 or schizophrenia;
- new strokes within 3 months before baseline;
- inherited or inflammatory small vessel disease;
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 cognitive training will be a multi-domain adaptive training program, including processing speed, attention, long-term memory, working memory, flexibility, calculation, and problem solving. Specific training paradigms include a time perception task, visual search task, attention blink, delayed mapping task, attention span task, Go-No go task, Stroop task, task switching, and name-face match task, among others. To maintain task difficulty, the tasks will be grouped based on the task difficulty in each domain. Furthermore, each task will have various difficulty levels. | Behavioural | training group |
| placebo 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 | control group |
Primary outcome
Estimated Mean Change of the Montreal Cognitive Assessment (MoCA)
Time frame: Baseline and 7 weeks
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive training. Baseline and 7-week were the two relevant time points used in the calculation. The score of MoCA ranges from 0 to 30, and higher scores mean a better outcome.
Estimated Mean Change of the Trail Making Test (TMT) B-A
Time frame: Baseline and 7 weeks
The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The Trail Making Test is a commonly used neuropsychological test of visual attention and task-switching. In two timed tasks, subjects are asked to first connect numbers (Test A), then alternating numbers and letters (Test B), in sequential order as quickly as possible. Completion times, relating to cognitive processing speed and executive function (respectively) are represented as a difference (B-A). The change from baseline at week 7 in the B-A difference is reported as a primar
3 secondary outcomes
Estimated Mean Changes in Left Hippocampal Volume
Time frame: Baseline and 7 weeks
Estimated Mean Change in Right Hippocampal Volume
Time frame: Baseline and 7 weeks
Estimated Mean Change in Brain White Matter Integrity
Time frame: Baseline and 7 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38828650Li QG, Xing Y, Zhu ZD, Fei XL, Tang Y, Lu J. Effects of computerized cognitive training on functional brain networks in patients with vascular cognitive impairment and no dementia. CNS Neurosci Ther. 2024 Jun;30(6):e14779. doi: 10.1111/cns.14779.
- Derived from this study: PubMed 27496126Tang Y, Zhu Z, Liu Q, Li F, Yang J, Li F, Xing Y, Jia J. The efficacy of Cognitive training in patients with VAsCular Cognitive Impairment, No dEmentia (the Cog-VACCINE study): study protocol for a randomized controlled trial. Trials. 2016 Aug 5;17(1):392. doi: 10.1186/s13063-016-1523-x.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yi Tang, M.D., Ph.D. principal investigator
Beijing Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing multi-domain internet-based adaptive training program in people with Vascular Cognitive Impairment no Dementia, run by Beijing Friendship Hospital 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 8 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: finished, as of the sponsor's last update on 23 Jul 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 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 23 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Estimated Mean Change of the Montreal Cognitive Assessment (MoCA) (time frame: Baseline and 7 weeks). 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 NCT02640716, which also lists 2 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 23 Jul 2020.