COG-REAGENT: COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT

July 17, 2023 updated by: Xuanwu Hospital, Beijing

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
260

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100053
        • Recruiting
        • Xuanwu Hospital, Capital Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Literate Han Chinese, 50-85 years of age with a caregiver that accompanies the subject consistently at least 4 days a week;
  2. Complaint and/or informant report of a cognitive impairment lasting for at least 3 months;
  3. Clinical diagnosis of MCI according to the MCI core clinical criteria of the National Institute on Aging-Alzheimer's Association (NIA-AA) guidelines;
  4. A prominent manifestation of memory deficit with or without other cognitive domain impairments;
  5. Mini-Mental State Examination (MMSE) score ≥24, and Clinical dementia rating (CDR) = 0.5, and
  6. 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).

Exclusion Criteria:

  1. Severe aphasia, physical disabilities, or any other disease that may preclude completion of neuropsychological testing;
  2. A medical history of stroke with focal neurological features including hemiparesis, sensory loss, visual field deficits, and evidence of responsible lesions on MRI;
  3. Significant white matter lesions (Fazekas score = 3-6);
  4. Disorders other than aMCI that may affect cognition;
  5. Depression or other psychiatric disorders;
  6. Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, cancer, alcoholism, drug addiction;
  7. Use of medications that may affect cognitive functioning, including tranquilizers, anti-anxiolytics, hypnotics, nootropics, and cholinomimetic agents;
  8. Inability to undergo a brain MRI; and
  9. Other conditions that in the investigator's opinion might not be suitable for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive training group
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.
Behavioral: multi-domain internet-based adaptive training program
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 Comparator: Active-control group
Fixed, primary difficulty level tasks. 4 x 40 minutes per week, for 12 weeks.
Behavioral: active-control program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
12 weeks (end of intervention)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
Time Frame: 12 weeks (end of intervention), 6 months
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.
12 weeks (end of intervention), 6 months
Change in brain volume and white matter integrity
Time Frame: 12 weeks (end of intervention), 6 months
Structural MRI will be used to measure brain volume and white matter integrity.
12 weeks (end of intervention), 6 months
Change in brain connectivity
Time Frame: 12 weeks (end of intervention), 6 months
Functional MRI will be used to measure brain connectivity.
12 weeks (end of intervention), 6 months
Change in Mini-mental State Examination
Time Frame: 12 weeks (end of intervention), 6 months
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.
12 weeks (end of intervention), 6 months
Change in Montreal Cognitive Assessment
Time Frame: 6 months
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.
6 months
Change in memory function
Time Frame: 12 weeks (end of intervention), 6 months
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.
12 weeks (end of intervention), 6 months
Change in Digit span forward
Time Frame: 12 weeks (end of intervention), 6 months
Digit span will be used to assess attention. It ranges from 3 to 10, and higher value represents a better outcome.
12 weeks (end of intervention), 6 months
Change in Digit span backward
Time Frame: 12 weeks (end of intervention), 6 months
Digit span backward will be used to assess executive function. It ranges from 2 to 8, and higher value represents a better outcome.
12 weeks (end of intervention), 6 months
Change in Trail Making Test
Time Frame: 12 weeks (end of intervention), 6 months
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.
12 weeks (end of intervention), 6 months
Change in Boston Naming Test
Time Frame: 12 weeks (end of intervention), 6 months
Boston Naming Test will be used to assess language function. It ranges from 0 to 30, and higher value represents a better outcome.
12 weeks (end of intervention), 6 months
Change in Activities of Daily Living
Time Frame: 12 weeks (end of intervention), 6 months
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.
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
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.
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
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.
12 weeks (end of intervention), 6 months
Change in Cookie Theft picture description task
Time Frame: 12 weeks (end of intervention), 6 months
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
12 weeks (end of intervention), 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xuanwu Hospital, Beijing

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Wuhan University
Beijing Friendship Hospital
First Affiliated Hospital Xi'an Jiaotong University
First Affiliated Hospital of Zhejiang University
Shandong Provincial Hospital
The First Hospital of Jilin University
The First Affiliated Hospital of Shanxi Medical University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yi Tang, M.D., Ph.D., Xuanwu Hospital, Beijing

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 6, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 21, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 19, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 17, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019042-XZ1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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