Ignite Creation Date:
2025-12-24 @ 11:24 PM
Ignite Modification Date:
2026-01-02 @ 4:40 PM
Study NCT ID:
NCT04063956
Status:
UNKNOWN
Last Update Posted:
2023-07-19
First Post:
2019-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
COG-REAGENT: COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT
Sponsor:
Xuanwu Hospital, Beijing
Organization:
Study Overview
Official Title:
The Efficacy of COGnitive tRaining in patiEnts With Amnestic Mild coGnitive impairmENT (COG-REAGENT): a Multi-center Randomized Controlled Trial
Status:
UNKNOWN
Status Verified Date:
2022-07
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: