CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI) (CTA-MCI)
Primary Purpose
Amnestic Mild Cognitive Impairment
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
internet-based adaptive cognitive control training program
placebo program
Sponsored by

About this trial
This is an interventional treatment trial for Amnestic Mild Cognitive Impairment focused on measuring cognitive control training, aMCI, MRI, RCT
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
- The First Affiliated Hospital, Zhejiang UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
training group
control group
Arm Description
Intervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks.
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks.
Outcomes
Primary Outcome Measures
Montreal Cognitive Assessment (MoCA)
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
Auditory Verbal Learning Test (AVLT)
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
Secondary Outcome Measures
Gray matter volume
The study uses voxel-based morphometry (VBM) to measure changes of gray matter volume after an intervention of cognitive training.
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
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
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
Full Information
NCT ID
NCT03133052
First Posted
April 1, 2017
Last Updated
February 18, 2019
Sponsor
First Affiliated Hospital of Zhejiang University
1. Study Identification
Unique Protocol Identification Number
NCT03133052
Brief Title
CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)
Acronym
CTA-MCI
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2017 (Actual)
Primary Completion Date
November 2019 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
First Affiliated Hospital of Zhejiang University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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). 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amnestic Mild Cognitive Impairment
Keywords
cognitive control training, aMCI, MRI, RCT
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
training group
Arm Type
Active Comparator
Arm Description
Intervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks.
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks.
Intervention Type
Behavioral
Intervention Name(s)
internet-based adaptive cognitive control training program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
placebo program
Intervention Description
For the control group, a fixed, primary difficulty level program for all participants is set.
Primary Outcome Measure Information:
Title
Montreal Cognitive Assessment (MoCA)
Description
The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training
Time Frame
12 weeks
Title
Auditory Verbal Learning Test (AVLT)
Description
The study uses AVLT to assess changes in the episodic memory function after an intervention of cognitive control training
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Gray matter volume
Description
The study uses voxel-based morphometry (VBM) to measure changes of gray matter volume after an intervention of cognitive training.
Time Frame
12 weeks
Title
White matter Integrity
Description
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
Time Frame
12 weeks
Title
Brain response change
Description
The study uses task functional MRI (fMRI) to measure the brain response changes during the task after an intervention of cognitive control training
Time Frame
12 weeks
Title
Functional connectivity across regions
Description
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
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
MoCA
Description
The participants will be followed up 6 months after recruitment. The training is not mandatory after 12 weeks, but the training details will be acquired from the online system.
Time Frame
6 months
Title
AVLT
Description
The participants will be followed up 6 months after recruitment. The training is not mandatory after 12 weeks, but the training details will be acquired from the online system.
Time Frame
6 months
Title
Gray matter volume
Description
The participants will be followed up 6 months after recruitment. The training is not mandatory after 12 weeks, but the training details will be acquired from the online system.
Time Frame
6 months
Title
White matter Integrity
Description
The participants will be followed up 6 months after recruitment. The training is not mandatory after 12 weeks, but the training details will be acquired from the online system.
Time Frame
6 months
Title
Functional connectivity across regions
Description
The participants will be followed up 6 months after recruitment. The training is not mandatory after 12 weeks, but the training details will be acquired from the online system.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Junyang Wang
Phone
+86-571-87235101
Email
wjy999@foxmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Guoping Peng, Ph.D.
Email
pgpfc@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benyan Luo, Ph.D.
Organizational Affiliation
The First Affiliated Hospital, Zhejiang University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The First Affiliated Hospital, Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Junyang Wang
Email
wjy999@foxmail.com
First Name & Middle Initial & Last Name & Degree
Guoping Peng
Email
pgpfc@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30621794
Citation
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.
Results Reference
derived
Learn more about this trial
CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI)
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