Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

260

participants targeted

Target at P75+ for not_applicable

Timeline

Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

4.1 years study duration

First Submitted

Initial submission to the registry

August 19, 2019

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 21, 2019

Completed

3 months until next milestone

Study Start

First participant enrolled

November 6, 2019

Completed

4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed

Last Updated

July 19, 2023

Status Verified

July 1, 2022

Enrollment Period

4.1 years

First QC Date

August 19, 2019

Last Update Submit

July 17, 2023

Conditions

Amnestic Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

Change in Montreal Cognitive Assessment
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 Outcomes (14)

Change in Alzheimer's Disease Assessment Scale cognitive subscale (ADAS-cog, 11-items version).
12 weeks (end of intervention), 6 months
Change in brain volume and white matter integrity
12 weeks (end of intervention), 6 months
Change in brain connectivity
12 weeks (end of intervention), 6 months
Change in Mini-mental State Examination
12 weeks (end of intervention), 6 months
Change in Montreal Cognitive Assessment
6 months
+9 more secondary outcomes

Study Arms (2)

Cognitive training group

EXPERIMENTAL

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

Active-control group

ACTIVE COMPARATOR

Fixed, primary difficulty level tasks. 4 x 40 minutes per week, for 12 weeks.

Behavioral: active-control program

Interventions

multi-domain internet-based adaptive training programBEHAVIORAL

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.

Cognitive training group

active-control programBEHAVIORAL

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.

Active-control group

Eligibility Criteria

Age50 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

Severe aphasia, physical disabilities, or any other disease that may preclude completion of neuropsychological testing;
A medical history of stroke with focal neurological features including hemiparesis, sensory loss, visual field deficits, and evidence of responsible lesions on MRI;
Significant white matter lesions (Fazekas score = 3-6);
Disorders other than aMCI that may affect cognition;
Depression or other psychiatric disorders;
Clinically significant gastrointestinal, renal, hepatic, respiratory, infectious, endocrine, or cardiovascular diseases, 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; and
Other conditions that in the investigator's opinion might not be suitable for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Xuanwu Hospital, Beijinglead
The First Affiliated Hospital of Shanxi Medical Universitycollaborator
Shandong Provincial Hospitalcollaborator
First Affiliated Hospital of Zhejiang Universitycollaborator
The First Hospital of Jilin Universitycollaborator
Beijing Friendship Hospitalcollaborator
First Affiliated Hospital Xi'an Jiaotong Universitycollaborator
Wuhan Universitycollaborator

Study Sites (1)

Xuanwu Hospital, Capital Medical University

Beijing, 100053, China

RECRUITING

Related Publications (1)

Xing Y, Zhu Z, Du Y, Zhang J, Qu Q, Sun L, Li Y, Guo Y, Peng G, Liu Y, Yu Y, Qiao Y, Xie B, Shi X, Lu J, Jia J, Tang Y. The Efficacy of COGnitive tRaining in patiEnts with Amnestic mild coGnitive impairmENT (COG-REAGENT): Protocol for a Multi-Center Randomized Controlled Trial. J Alzheimers Dis. 2020;75(3):779-787. doi: 10.3233/JAD-191314.
PMID: 32333590DERIVED

Study Officials

Yi Tang, M.D., Ph.D.
Xuanwu Hospital, Beijing
PRINCIPAL INVESTIGATOR

Central Study Contacts

Yi Tang, M.D., Ph.D.

CONTACT

008613811021432 tangyixw@vip.163.com

Yi Xing, M.D.

CONTACT

008613269627589 xingyi_211@163.com

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: DOUBLE
Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

August 19, 2019

First Posted

August 21, 2019

Study Start

November 6, 2019

Primary Completion

December 1, 2023

Study Completion

December 1, 2023

Last Updated

July 19, 2023

Record last verified: 2022-07

Locations

CN(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (14)

Study Arms (2)

Cognitive training group

Active-control group

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (1)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Locations