Amnestic Mild Cognitive ImpairmentCTA-MCINCT03133052
CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)
A study of Amnestic Mild Cognitive Impairment, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Amnestic Mild Cognitive Impairment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 9 Jul 2017to Apr 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Literate Chinese, aged 50 years and older
- Complaint about memory loss and confirmed by an informant
- Cognitive impairment in memory domain, adjusted for age and education
- Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- Clinical dementia rating (CDR) =0.5, Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)
- Failure to meet the criteria for dementia
Who cannot join
- history of clinically significant stroke
- neurological diseases that may lead to neurological distortion, including schizophrenia, severe anxiety or depression, frontotemporal dementia，Huntington disease, brain tumor, parking disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus
- systemic diseases that may lead to neurological distortion, including hypothyroidism, folic acid deficiency, vitamin B12 deficiency, severe anemia, specific infection such as HIV and syphilis
- clinically significant gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease;
- cancer, alcoholism, drug addiction;
- severe aphasia, physical disabilities, or any other factor that may preclude completion of neuropsychological testing;
- 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.
Guoping Peng, Ph.D. contact
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang
Junyang Wang, wjy999@foxmail.com
Guoping Peng, pgpfc@163.com
About this study
Official title: The CTA-MCI Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Control Training on Episodic Memory Function in Patients With Amnestic Mild Cognitive Impairment
This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half of participants will receive adaptive internet-based cognitive control training program, while the other half will receive a fixed, primary difficulty level task.
Read the detailed description
Background:
Alzheimer's disease (AD) is a common dementia in elderly populations, and amnestic mild cognitive impairment (aMCI) refers to a transitional stage between normal aging and early dementia. Patients with aMCI are at higher risks of evolving toward AD. Although it has been widely recognized that early intervention of aMCI holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Episodic memory dysfunction is the characteristic impairment in aMCI, cognitive control training significantly improved executive function in patients with aMCI . Whether and how cognitive control training improves episodic memory function in patients with aMCI remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive control training in patients with amnestic Mild Cognitive Impairment improves their episodic memory function. The second objective is to evaluate the effect of cognitive control training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI.
Patients and Methods:
The proposed study is a single-center, double-blinded, randomized controlled trial that will include 70 patients diagnosed with aMCI from the neurology clinics at The First Affiliated Hospital, Zhejiang University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive control training performed for 30 minutes over 60 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 12 weeks after training.
Relevance:
Currently there is no known treatment available for aMCI. The proposed study is to determine the efficacy of cognitive control training on episodic memory function in patients with aMCI. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive control training.
- Conditions
- Amnestic Mild Cognitive Impairment
- Being tested
- internet-based adaptive cognitive control training program, placebo program
- Keywords
- cognitive control training, aMCI, MRI, RCT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internet-based adaptive cognitive control training programBehavioural
The cognitive training will be an internet-based adaptive cognitive control training program, specific training paradigms include Flanker, 1-back, 2-back. To maintain task difficulty, the tasks will be grouped based on the task difficulty. Furthermore, each task will have various difficulty levels.
placebo programBehavioural
For the control group, a fixed, primary difficulty level program for all participants is set.
| Study group | Role | What they receive |
|---|---|---|
| training group | Active comparator | Intervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks. Receives: Behavioral: internet-based adaptive cognitive control training program |
| control group | Placebo comparator | Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks. Receives: Behavioral: placebo program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Montreal Cognitive Assessment (MoCA)
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
Measured: 12 weeks
Auditory Verbal Learning Test (AVLT)
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
Measured: 12 weeks
Secondary outcomes (4)
Gray matter volume
The study uses voxel-based morphometry (VBM) to measure changes of gray matter volume after an intervention of cognitive training.
Measured: 12 weeks
White matter Integrity
The study uses Diffusion tensor imaging and tracking (DTI) to measure changes of the Integrity of white matter after an intervention of cognitive control training
Measured: 12 weeks
Brain response change
The study uses task functional MRI (fMRI) to measure the brain response changes during the task after an intervention of cognitive control training
Measured: 12 weeks
Functional connectivity across regions
The study uses resting state functional MRI(rs-fMRI) and task fMRI to measure changes of functional connectivity across regions after an intervention of cognitive control training
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2017
- Study start9 Jul 2017
- Primary completionNov 2019 (estimated)
- Study completionApr 2020 (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 First Affiliated Hospital of Zhejiang UniversityThe 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
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benyan Luo, Ph.D., Principal investigator, First Affiliated Hospital of Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03133052
- Sponsor's protocol ID
- DTCI-cognitive training
- Acronym
- CTA-MCI
- Status last verified
- Jan 2019
- First submitted
- 1 Apr 2017
- Last updated
- 19 Feb 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang K, Wang J, Peng G, Liu P, He F, Zhu Z, Luo B. Effect of cognitive training on episodic memory retrieval in amnestic mild cognitive impairment patients: study protocol for a clinical randomized controlled trial. Trials. 2019 Jan 8;20(1):26. doi: 10.1186/s13063-018-3143-0.
PubMed 30621794
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The CTA-MCI Study: a Randomized Controlled Clinical Trial to Evaluate the Effect of Cognitive Control Training on Episodic Memory Function in Patients With Amnestic Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03133052
- Acronym / sponsor ID
- CTA-MCI / DTCI-cognitive training
- Conditions
- Amnestic Mild Cognitive Impairment
- Keywords
- cognitive control training, aMCI, MRI, RCT
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Study start
- 9 Jul 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 28 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the efficacy and mechanism of internet-based cognitive control training on episodic memory function in patients with amnestic Mild Cognitive Impairment(aMCI). Half of participants will receive adaptive internet-based cognitive control training program, while the other half will receive a fixed, primary difficulty level task.
Detailed description
Background:
Alzheimer's disease (AD) is a common dementia in elderly populations, and amnestic mild cognitive impairment (aMCI) refers to a transitional stage between normal aging and early dementia. Patients with aMCI are at higher risks of evolving toward AD. Although it has been widely recognized that early intervention of aMCI holds the potential to delay or even reverse the cognitive impairment, no treatment is available yet. Episodic memory dysfunction is the characteristic impairment in aMCI, cognitive control training significantly improved executive function in patients with aMCI . Whether and how cognitive control training improves episodic memory function in patients with aMCI remains largely unknown.
Objectives:
The primary objective of this double-blinded, randomized RCT is to assess whether internet-based cognitive control training in patients with amnestic Mild Cognitive Impairment improves their episodic memory function. The second objective is to evaluate the effect of cognitive control training on neural plasticity, including brain activation and white matter integrity, which are assessed by functional and structural MRI.
Patients and Methods:
The proposed study is a single-center, double-blinded, randomized controlled trial that will include 70 patients diagnosed with aMCI from the neurology clinics at The First Affiliated Hospital, Zhejiang University. The patients will be randomized to either a training or a control group. The intervention is internet-based cognitive control training performed for 30 minutes over 60 sessions. Neuropsychological assessment and functional magnetic resonance imaging (MRI) will be performed before and 12 weeks after training.
Relevance:
Currently there is no known treatment available for aMCI. The proposed study is to determine the efficacy of cognitive control training on episodic memory function in patients with aMCI. Secondly, using functional and structural MRI, this study is to reveal the potential mechanism underlying cognitive control 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: internet-based adaptive cognitive control training programIntervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks. |
| control group | Placebo comparator | Behavioral: placebo programIntervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Literate Chinese, aged 50 years and older
- Complaint about memory loss and confirmed by an informant
- Cognitive impairment in memory domain, adjusted for age and education
- Normal or near-normal performance on general cognitive function and no or minimum impairment of daily life activities
- Clinical dementia rating (CDR) =0.5, Mini-Mental State Examination (MMSE) score ≥ 20 (primary school) or ≥ 24 (junior school or above)
Key exclusion criteria (8 listed)
- history of clinically significant stroke
- neurological diseases that may lead to neurological distortion, including schizophrenia, severe anxiety or depression, frontotemporal dementia，Huntington disease, brain tumor, parking disease, metabolic encephalopathy, encephalitis, multiple sclerosis, epilepsy, brain trauma, normal pressure hydrocephalus
- systemic diseases that may lead to neurological distortion, including hypothyroidism, folic acid deficiency, vitamin B12 deficiency, severe anemia, specific infection such as HIV and syphilis
- clinically significant gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease;
- cancer, alcoholism, drug addiction;
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 |
|---|---|---|
| internet-based adaptive cognitive control training programThe cognitive training will be an internet-based adaptive cognitive control training program, specific training paradigms include Flanker, 1-back, 2-back. To maintain task difficulty, the tasks will be grouped based on the task difficulty. Furthermore, each task will have various difficulty levels. | Behavioural | training group |
| placebo programFor the control group, a fixed, primary difficulty level program for all participants is set. | Behavioural | control group |
Primary outcome
Montreal Cognitive Assessment (MoCA)
Time frame: 12 weeks
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
Auditory Verbal Learning Test (AVLT)
Time frame: 12 weeks
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
4 secondary outcomes
Gray matter volume
Time frame: 12 weeks
White matter Integrity
Time frame: 12 weeks
Brain response change
Time frame: 12 weeks
Functional connectivity across regions
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2019.
- Derived from this study: PubMed 30621794Zhang K, Wang J, Peng G, Liu P, He F, Zhu Z, Luo B. Effect of cognitive training on episodic memory retrieval in amnestic mild cognitive impairment patients: study protocol for a clinical randomized controlled trial. Trials. 2019 Jan 8;20(1):26. doi: 10.1186/s13063-018-3143-0.
- 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.
Guoping Peng, Ph.D. contact
Benyan Luo, Ph.D. principal investigator
First Affiliated Hospital of Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Amnestic Mild Cognitive Impairment, run by First Affiliated Hospital of Zhejiang 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 8 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 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Junyang Wang (+86-571-87235101, wjy999@foxmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Montreal Cognitive Assessment (MoCA) (time frame: 12 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 NCT03133052, 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 Feb 2019.