Computerized Cognitive Training for MCI

NCT03232047 | Unknown DMC

• 1 other identifier: Z161100000516001
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate whether memory training combined with executive training could lead to improved cognitive and noncognitive performance in patients with MCI. Furthermore, we will explore the neural correlates underlying the changed performances.

Conditions

Mild Cognitive Impairment

Keywords

Computerized, Executive function, memory, cognitive training; Mild Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Composite working memory z score

  composite score of digit span and spatial span

  Change from baseline composite working memory z score at week 26

Secondary Outcomes (9)

• cognitive test package (CTP)

  Changes from baseline composite CTP score at week 26

• Self evaluated memory ability

  Change from baseline self evaluated memory ability at week 26

• Brain Functional Imaging

  change from baseline functional connectivity at week 26

• Electrical activity of the brain

  change from baseline electrical brain activity at week 26

• Brain structural imaging

  change from baseline cortical thickness at week 26

Study Arms (2)

Combined cognitive training

EXPERIMENTAL

The training is combined executive function and memory training. The training is considered 'adaptive', which means that the difficulty level of the tasks increases during the sessions according to the individual level of mastering for each participant, making the patient work at their maximum capacity at all times.

Device: Combined executive function and memory training

Waiting-list group

NO INTERVENTION

Participants in the control condition will conduct the same training as the intervention group after a 26-week waiting period. During the 26-week waiting period, the participants will receive assessment with the same protocol as the interventional group.

Interventions

Combined executive function and memory training DEVICE

Computerized combined executive function and memory training

Combined cognitive training

Eligibility Criteria

• Age: 60 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• An objective cognition impairment (a Montreal Cognitive Assessment (MoCA) score \< 26)
• Preserved general cognitive function( an mini-mental state examination (MMSE) score of \> 24)
• Clinical Dementia Rating (CDR) = 0.5
• Hamilton Depression Scale (HAMD) score of \< 12
• Intact activities of daily living (ADL score of \<=26)
• Schooling education \> = 5 years)
• Not meeting the diagnosis of dementia (according to the 10th revision of the International Statistical Classification of Diseases and Related Health Problems (ICD-10) and the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) Probable Alzheimer's Criteria

You may not qualify if:

• Serious visual or hearing impairment;
• Hachinski Ischemia Scale (HIS) \>= 4;
• Subjects with Axis I disorders listed in the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV), any other neurological disorders that could affect cognitive function;
• currently on titration of medications with cognitive enhancers or antidepressants;
• having any physical condition that could preclude regular attendance and full intervention-program participation

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Institute of Mental Health(Six Hospital)

Beijing, Beijing Municipality, 100191, China

RECRUITING

Related Publications (1)

• Zhang H, Wang J, Sun T, Wang Z, Lyu X, Yu X, Wang H. A randomized controlled trial of combined executive function and memory training on the cognitive and noncognitive function of individuals with mild cognitive impairment: Study rationale and protocol design. Alzheimers Dement (N Y). 2018 Oct 15;4:556-564. doi: 10.1016/j.trci.2018.09.004. eCollection 2018.

  PMID: 30386820 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Huali Wang, MD

  Peking University Institute of Mental Health(Sixth hospital)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Huali Wang, MD

CONTACT

+86-10-82801983; huali_wang@bjmu.edu.cn

Haifeng Zhang, MS

CONTACT

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Clinical Research Division

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: July 27, 2017
• Study Start: August 1, 2017
• Primary Completion: December 1, 2019
• Study Completion: December 31, 2019
• Last Updated: March 21, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)