Mild Cognitive ImpairmentNCT03232047
Computerized Cognitive Training for MCI
A study testing Combined executive function and memory training in people with Mild Cognitive Impairment, run by Peking University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 89 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Combined executive function and memory training
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2017to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Haifeng Zhang, MS contact
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Mental Health(Six Hospital)
Beijing, Beijing Municipality, 100191
Haifeng Zhang, MS, 86+18813185360, zhfphd@gmail.com
Xiaozhen Lv, PhD, 86+82801983, lxz120300@163.com
About this study
Official title: A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
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.
Read the detailed description
Introduction:
Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia, but are more pronounced than the cognitive decline associated with normal aging. The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these individuals seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Thus, MCI represents a critical window of opportunity for intervening and altering the trajectory of both cognitive decline and loss of functional independence in older adults. Cognitive function apart from memory such as executive function is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis on the training of executive function.
Objectives:
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.
Patients and Methods:
The proposed study is a single blinded, randomized and controlled trial that will include 120 elderly patients with MCI from the memory clinic. The groups will be randomized to either intervention or waiting-list group. The intervention is computerized combined memory and executive function training performed for 60 minutes x 4 times/week over 26 weeks. A neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after the intervention. The structural and functional MRI, EEG and NIRS will be performed at baseline and week 26 after intervention for a sub-study on the effect of cognitive training on brain structure and function.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Combined executive function and memory training
- Keywords
- Computerized, Executive function, memory, cognitive training, Mild Cognitive Impairment
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined executive function and memory trainingDevice
Computerized combined executive function and memory training
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite working memory z score
composite score of digit span and spatial span
Measured: Change from baseline composite working memory z score at week 26
Secondary outcomes (9)
cognitive test package (CTP)
composite score of episodic memory, speed processing, executive function, attention, language and social cognition
Measured: Changes from baseline composite CTP score at week 26
Self evaluated memory ability
Score on the questionnaire probes worries about memory (MMQ-contentment).
Measured: Change from baseline self evaluated memory ability at week 26
Brain Functional Imaging
Brain function measured with MRI.
Measured: change from baseline functional connectivity at week 26
Electrical activity of the brain
Brain activity measured with electroencephalography (EEG).
Measured: change from baseline electrical brain activity at week 26
Brain structural imaging
cortical thickness measured with MRI
Measured: change from baseline cortical thickness at week 26
cerebral blood flow
Cerebral blood flow measured with Near-infrared spectroscopy (NIRS).
Measured: change from baseline cerebral blood flow at week 26
Mood
composite score of mood status
Measured: Change from baseline composite mood score at week 26
BDNF level
Serum Brain-derived neurotrophic factor (BDNF) level
Measured: change from baseline serum BDNF level at week 26
Composite of overall cognition z scores
Score on Montreal Cognitive Assessment (MoCA) and Mini-mental State Examination (MMSE).
Measured: Changes from baseline composite overall cognition z score at week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Dec 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Huali Wang, Peking University
- Investigators
- Huali Wang, MD, Principal investigator, Peking University Institute of Mental Health(Sixth hospital)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232047
- Sponsor's protocol ID
- Z161100000516001
- Status last verified
- Mar 2019
- First submitted
- 22 Jul 2017
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30386820
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Control Trial on Computerized Cognitive Training for Individuals With Mild Cognitive Impairment
- ClinicalTrials.gov ID
- NCT03232047
- Acronym / sponsor ID
- Z161100000516001
- Conditions
- Mild Cognitive Impairment
- Keywords
- Computerized, Executive function, memory, cognitive training, Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 27 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Introduction:
Mild cognitive impairment (MCI) is a clinical condition characterized of a reduction in memory and/or other cognitive processes that are insufficiently severe to be diagnosed as dementia, but are more pronounced than the cognitive decline associated with normal aging. The prevalence of MCI ranges from 3% to 19% in adults older than 65 years; some of these individuals seem to remain stable or return to normal over time, but more than half progress to dementia within 5 years. Thus, MCI represents a critical window of opportunity for intervening and altering the trajectory of both cognitive decline and loss of functional independence in older adults. Cognitive function apart from memory such as executive function is also impaired in patients with MCI. However, no study has yet placed sufficient emphasis on the training of executive function.
Objectives:
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.
Patients and Methods:
The proposed study is a single blinded, randomized and controlled trial that will include 120 elderly patients with MCI from the memory clinic. The groups will be randomized to either intervention or waiting-list group. The intervention is computerized combined memory and executive function training performed for 60 minutes x 4 times/week over 26 weeks. A neuropsychological assessment will be administered at baseline and week 4, 12 and 26 after the intervention. The structural and functional MRI, EEG and NIRS will be performed at baseline and week 26 after intervention for a sub-study on the effect of cognitive training on brain structure and function.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined cognitive training | Experimental | Device: Combined executive function and memory trainingThe 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. |
| 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. |
Who may qualify
- Ages
- 60 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combined executive function and memory trainingComputerized combined executive function and memory training | Device | Combined cognitive training |
Primary outcome
Composite working memory z score
Time frame: Change from baseline composite working memory z score at week 26
composite score of digit span and spatial span
9 secondary outcomes
cognitive test package (CTP)
Time frame: Changes from baseline composite CTP score at week 26
Self evaluated memory ability
Time frame: Change from baseline self evaluated memory ability at week 26
Brain Functional Imaging
Time frame: change from baseline functional connectivity at week 26
Electrical activity of the brain
Time frame: change from baseline electrical brain activity at week 26
Brain structural imaging
Time frame: change from baseline cortical thickness at week 26
cerebral blood flow
Time frame: change from baseline cerebral blood flow at week 26
Mood
Time frame: Change from baseline composite mood score at week 26
BDNF level
Time frame: change from baseline serum BDNF level at week 26
Composite of overall cognition z scores
Time frame: Changes from baseline composite overall cognition z score at week 26
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2019.
- Derived from this study: PubMed 30386820Zhang 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.
- Individual participant dataSharing planned: No
Related trials for Mild Cognitive Impairment
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
RecruitingObservational study
Loneliness as Risk Factor for Dementia
Mild Cognitive Impairment (MCI), Dementia (Diagnosis)
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of KarXT + KarX-EC for Cognitive Impairment in Alzheimer's Disease
Alzheimer's Disease
Recruiting
Combating Alzheimer's Through Sleep and Exercise
Dementia, Mild Cognitive Impairment (MCI)
Active, not recruiting
EFFECTS OF AN OUTDOOR MAT PILATES PROGRAM ON NEUROPHYSIOLOGICAL INDICATORS OF ELDERLY INDIVIDUALS WITH MILD COGNITIVE IMPAIRMENT
Cognition Disorders
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haifeng Zhang, MS contact
Huali Wang, MD principal investigator
Peking University Institute of Mental Health(Sixth hospital)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combined executive function and memory training in people with Mild Cognitive Impairment, run by Peking University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Huali Wang, MD (+86-10-82801983, huali_wang@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite working memory z score (time frame: Change from baseline composite working memory z score at week 26). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03232047, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2019.