CTA-MCI: Cognitive Control Training in Patients With Amnestic Mild Cognitive Impairment(CTA-MCI) (CTA-MCI)

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.

Study Overview

• Status: Unknown
• Conditions: Amnestic Mild Cognitive Impairment
• Intervention / Treatment: Behavioral: internet-based adaptive cognitive control training program; Behavioral: placebo program

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 Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Junyang Wang; Phone Number: +86-571-87235101; Email: wjy999@foxmail.com
• Study Contact Backup: Name: Guoping Peng, Ph.D.; Email: pgpfc@163.com

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China
      • Recruiting
      • The First Affiliated Hospital, Zhejiang University
      • Contact: Junyang Wang; Email: wjy999@foxmail.com
      • Contact: Guoping Peng; Email: pgpfc@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: training group; Intervention: Internet-based adaptive cognitive control training program. 5 x 30 minutes per week, for 12 weeks.	Behavioral: internet-based adaptive cognitive control training program; 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 Comparator: control group; Intervention: placebo program: a fixed, primary difficulty level task. 5 x 30 minutes per week, for 12 weeks.	Behavioral: placebo program; For the control group, a fixed, primary difficulty level program for all participants is set.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Montreal Cognitive Assessment (MoCA)	The study uses MoCA to assess changes in the global cognitive function after an intervention of cognitive control training	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	12 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gray matter volume	The study uses voxel-based morphometry (VBM) to measure changes of gray matter volume after an intervention of cognitive training.	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	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	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	12 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
MoCA	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.	6 months
AVLT	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.	6 months
Gray matter volume	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.	6 months
White matter Integrity	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.	6 months
Functional connectivity across regions	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.	6 months

Collaborators and Investigators

• Sponsor: First Affiliated Hospital of Zhejiang University
• Investigators: Principal Investigator: Benyan Luo, Ph.D., The First Affiliated Hospital, Zhejiang University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2017
• Primary Completion (Anticipated): November 1, 2019
• Study Completion (Anticipated): April 1, 2020

Study Registration Dates

• First Submitted: April 1, 2017
• First Submitted That Met QC Criteria: April 25, 2017
• First Posted (Actual): April 28, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2019
• Last Update Submitted That Met QC Criteria: February 18, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: MRI; RCT; cognitive control training; aMCI
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: DTCI-cognitive training

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No