Cognitive DysfunctionSIMPLENCT03119051

Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment

A study testing Online cognitive training and Cognitive training plus physical exercise in people with Cognitive Dysfunction, run by Ruijin Hospital at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 50 to 85 years
Conditions the study is for: Cognitive Dysfunction
What is being tested?: Online cognitive training and Cognitive training plus physical exercise
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 1 siteChina
Study dates: 15 May 2017to May 2021
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 50 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female, aged 50-85;
MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups[1];
24≤Mini-Mental State Examination (MMSE) ≤28；
The Hamilton Depression Scale/17-item (HAMD) score ≤10;
Not on medication for dementia;
MRI T2 weighted image (T2WI) scan: aged ≤70 , Fazeca scale for White Matter lesions rating level≤1; >70 years, white matter damage rating scale ≤2. The number of lacunar infarcts larger than 2 cm in diameter ≤2. No infarcts in hypothalamus, entorhinal cortex, para-hypothalamus, cortical and subcortical cavity infarction near gray matter nuclei. The medial temporal lobe atrophy (MTA) score: Grade II or above.

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Accompanied by reliable caregivers (at least intensive contact of 4 days every week and 2 hours every day) who are expected to participate in the follow-up visits and provide useful information for scores of scales like ADCS-ADL;
Education level: primary school (grade 6) or above.
Expected good compliance with the therapy and follow-up. Each patient gives a written informed consent, and the study has been approved by Ruijin Hospital's ethical committees.

Who cannot join

Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
History of alcohol or drug abuse;
Participation in other clinical trial less than 30 days before the screening of this study;
Inability to complete the study.

Trial locations and contacts

1 site in 1 country.

Sheng-Di Chen contact

86-21-6445-4473

chen_sd@medmail.com.cn

China1 site, 1 recruiting

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200002
Binyin Li, Dr, 86-13681884221, libinyin@126.com
Yiqi Lin, Dr, 86-021-64454473, linyiqi@126.com
Recruiting

Other trials in China

About this study

Official title: Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation

This study evaluates the effects of "computerized cognitive training" and "cognitive training plus exercise training" on different cognitive domains in mild cognitive impairment (MCI) patients. Patients will be randomized into the computerized training group, cognitive training plus exercise training group and the control group.

Read the detailed description

Mild cognitive impairment (MCI) is an early stage of Alzheimer Disease (AD). Increasing evidence has indicated that cognitive trainings improve cognition functions of MCI patients in multiple cognitive domains, making it a promising therapy for MCI. However, the effect of long-time training has not been widely explored. It is also necessary to evaluate the extent of its function in reducing the conversion rate from MCI to AD.

Conditions: Cognitive Dysfunction
Being tested: Online cognitive training, Cognitive training plus physical exercise
Keywords: 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.

Online cognitive trainingBehavioural
A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
Cognitive training plus physical exerciseBehavioural
Online cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.
Physical Exercise Tai Chi Training：a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction.

Study groups in NCT03119051
Study group	Role	What they receive
online cognitive training	Experimental	Patients will receive 3-4 times of 20-30 minutes' training game every week Receives: Behavioral: Online cognitive training
no training	No intervention	Patients will not undergo preoperative cognitive training.
Cognitive training and physical exercise	Experimental	Patients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training Receives: Behavioral: Cognitive training plus physical exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

Incidence of AD
The 3-year incidence of AD in each group will be compared.
Measured: 12 months

Secondary outcomes (9)

The global cognitive function of MCI patients
Alzheimer disease assessment scale (ADAS-Cog) will be used to assess the global cognitive performance of MCI patients
Measured: 6 months
Memory
Memory will be assessed using the Auditory verbal learning test-Huashan version (AVLT-H).
Measured: 12 months
Attention
Attention will be evaluated by Trial Making Test (TMT).
Measured: 12 months
Executive functions
Executive functions will be evaluated by the Stroop task.
Measured: 12 months
Language
Language will be assessed by Boston naming test (30-item version).
Measured: 12 months
Visual spatial ability and visual memory
Visual spatial ability and visual memory will be evaluated by the Rey-Osterrieth complex figure test (CFT).
Measured: 12 months
Activities of daily living
Activities of daily living will be assessed by Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL).
Measured: 6 months
Structural MRI
Volume of hippocampus and other specific brain regions
Measured: 12 months
Gut microbiota
Number of genera and abundence of E.coli in feces and blood
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 May 2017May 2021

First posted18 Apr 2017
Study start15 May 2017
Primary completionMar 2021 (estimated)
Study completionMay 2021 (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 Cognitive DysfunctionStudies of the same condition, open and under way.
More trials run by Ruijin HospitalThe sponsor's other registered studies.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 250 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03119051
Sponsor's protocol ID: RuijinHSH
Acronym: SIMPLE
Status last verified: Aug 2020
First submitted: 4 Apr 2017
Last updated: 17 Aug 2020
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.
PubMed 30041656

Want to know more?

Sheng-Di Chen

86-21-6445-4473

chen_sd@medmail.com.cn

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Dysfunction trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Shanghai Non-pharmacological Intervention of Mild Cognitive Impairment for Delaying Progress With Longitudinal Evaluation
ClinicalTrials.gov ID: NCT03119051
Acronym / sponsor ID: SIMPLE / RuijinHSH
Conditions: Cognitive Dysfunction
Keywords: mild cognitive impairment
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 250 participants (estimated)
Lead sponsor: Ruijin HospitalUniversity, hospital or other
Collaborators: RenJi Hospital, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Huashan Hospital
Study start: 15 May 2017 (actual)
Primary completion: Mar 2021 (estimated)
Study completion: May 2021 (estimated)
First posted: 18 Apr 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
online cognitive training	Experimental	Behavioral: Online cognitive trainingPatients will receive 3-4 times of 20-30 minutes' training game every week
no training	No intervention	–Patients will not undergo preoperative cognitive training.
Cognitive training and physical exercise	Experimental	Behavioral: Cognitive training plus physical exercisePatients will receive 3-4 times of 20-30 minutes' training game every week and 2 times of 60 minutes' Tai Chi Training

Who may qualify

Ages: 50 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female, aged 50-85;
MCI diagnosed according to the National Institute on Aging-Alzheimer's Association (NIA-AA) workgroups[1];
24≤Mini-Mental State Examination (MMSE) ≤28；
The Hamilton Depression Scale/17-item (HAMD) score ≤10;
Not on medication for dementia;

Key exclusion criteria (7 listed)

Cognitive decline caused by other diseases (cerebrovascular disease, central nervous system infections, Parkinson's disease, metabolic encephalopathy, intracranial space-occupying lesions, deficiency of folic acid/vitamin B12 and hypothyroidism);
Medical history of other neurological disorders (including stroke, Neuromyelitis optica, Parkinson's disease, epilepsy, etc.);
Psychiatric disorders defined by (Diagnostic and Statistical Manual of Mental Disorders) DSM-IV criteria;
Unstable or severe disease of heart, lung, liver, kidney or hematopoietic system;
History of alcohol or drug abuse;

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
Online cognitive trainingA variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%.	Behavioural	online cognitive training
Cognitive training plus physical exerciseOnline cognitive training A variety of cognitive domains will be involved in the training including memory, calculation, attention, visuospatial and executive skills. The difficulty level of each game will be adjusted automatically according to patients' last training results so that patients' correction rate will be kept between 70% and 80%. Physical Exercise Tai Chi Training：a teacher will give two 60-min lessons per week. Participants will play Tai Chi in the lessons, following teacher's instruction.	Behavioural	Cognitive training and physical exercise

Primary outcome

Incidence of AD
Time frame: 12 months
The 3-year incidence of AD in each group will be compared.

9 secondary outcomes

The global cognitive function of MCI patients
Time frame: 6 months
Memory
Time frame: 12 months
Attention
Time frame: 12 months
Executive functions
Time frame: 12 months
Language
Time frame: 12 months
Visual spatial ability and visual memory
Time frame: 12 months
Activities of daily living
Time frame: 6 months
Structural MRI
Time frame: 12 months
Gut microbiota
Time frame: 12 months

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
Derived from this study: PubMed 30041656Lin Y, Li B, Tang H, Xu Q, Wu Y, Cheng Q, Li C, Xiao S, Shen L, Tang W, Yu H, He N, Lin H, Yan F, Cao W, Yang S, Liu Y, Zhao W, Lu D, Jiao B, Xiao X, Zhou L, Chen S. Shanghai cognitive intervention of mild cognitive impairment for delaying progress with longitudinal evaluation-a prospective, randomized controlled study (SIMPLE): rationale, design, and methodology. BMC Neurol. 2018 Jul 24;18(1):103. doi: 10.1186/s12883-018-1100-x.
Individual participant dataSharing planned: No

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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.

Sheng-Di Chen contact

86-21-6445-4473

chen_sd@medmail.com.cn

Sheng-Di Chen study director

Rui Jin Hospital affiliated to Shanghai Jiao Tong University School of Medicine

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Online cognitive training and Cognitive training plus physical exercise in people with Cognitive Dysfunction, run by Ruijin Hospital 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 9 inclusion and 7 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 17 Aug 2020. 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 Sheng-Di Chen (86-21-6445-4473, chen_sd@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of AD (time frame: 12 months). 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 NCT03119051, 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 17 Aug 2020.