Mild Cognitive ImpairmentSIM-2NCT05887674
Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease
A study testing Diet intervention, Exercise and Cognitive training in people with Mild Cognitive Impairment and Mild Dementia, run by Ruijin Hospital at 1 site in China.
Trial summary
This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 60 to 90 years
- Conditions the study is for
- Mild Cognitive Impairment, Mild Dementia
- What is being tested?
- Diet intervention, Exercise and Cognitive training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 11 May 2023to 30 Aug 2026
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60-90 years
- In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" or "mild Alzheimer's disease" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011)
- The Hamilton depression rating scale/17 edition (HAMD) total score≤10
- Neurological examination: no obvious signs
- Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability
- Capacity to give consent
Who cannot join
- Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's and Parkinson's disease, Creutzfeldt-Jakob disease, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia
- The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc
- Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium
- There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors.
- Vision or hearing problems that lead to poor performance on cognitive tests
- Two years history of severe alcoholism, and drug abuse
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- Participants who participated in any other trial 30 days prior to their screening visit
- Contraindication of MRI scanning
- Special requirements for diet, e.g., allergy to common food or on a special diet due to medical needs
- Participants who cannot be followed for at least 6 months (due to a health situation or migration)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200002
Binyin Li, Dr, 86-13681884221, libinyin@126.com
Xiaomeng Xu, Dr, 86-021-64454473, xuxiaomeng@163.com
About this study
Official title: Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease: Combined Low Inflammatory-index Diet, Physical Exercises, and Cognitive Training in Nursing Home
This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
Read the detailed description
This is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Being tested
- Diet intervention, Exercise, Cognitive training
- Keywords
- mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diet interventionBehavioural
Low inflammatory-index diet
ExerciseBehavioural
Guided muscle strength training and stretching exercises
Cognitive trainingBehavioural
Cognitive training will be implemented in person
| Study group | Role | What they receive |
|---|---|---|
| Multi-domain intervention group | Experimental | Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Receives: Behavioral: Diet intervention; Behavioral: Exercise; Behavioral: Cognitive training |
| Exercise and cognitive training | Experimental | Patients in this arm will receive the intervention of exercise and cognitive training. Receives: Behavioral: Exercise; Behavioral: Cognitive training |
| Standard health counseling at baseline | No intervention | Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline global cognitive function at one year
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Measured: One year
Change from baseline memory at one year
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Measured: One year
Change from baseline visual spatial ability and visual memory at one year
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
Measured: One year
Secondary outcomes (6)
Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
Executive function
Measured: One year
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
Neural connectivity by functional MRI
Measured: One year
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
Brain structure by MRI
Measured: One year
Changes in Inflammatory biomarkers
Serum interleukins and tumor necrosis factors
Measured: One year
Changes in gut microbiota
Number of genera and abundance of microbiota in feces and blood
Measured: One year
Changes in Metabolic biomarkers
Low-density lipoprotein, high-density lipoprotein, and total cholesterol
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start11 May 2023
- Primary completion30 Aug 2026 (estimated)
- Study completion30 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Sinopharm Nursing Care Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05887674
- Sponsor's protocol ID
- RJNeuroBank-SIM2
- Acronym
- SIM-2
- Status last verified
- Oct 2024
- First submitted
- 15 May 2023
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease: Combined Low Inflammatory-index Diet, Physical Exercises, and Cognitive Training in Nursing Home
- ClinicalTrials.gov ID
- NCT05887674
- Acronym / sponsor ID
- SIM-2 / RJNeuroBank-SIM2
- Conditions
- Mild Cognitive Impairment, Mild Dementia
- Keywords
- mild cognitive impairment, Alzheimer's disease, Diet, Physical exercise, Cognitive training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Collaborators
- Shanghai Sinopharm Nursing Care Center
- Study start
- 11 May 2023 (actual)
- Primary completion
- 30 Aug 2026 (estimated)
- Study completion
- 30 Aug 2026 (estimated)
- First posted
- 5 Jun 2023 (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.
This study is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease.
Detailed description
This is a multicentre, randomized, double-blind, controlled trial that aims to investigate the efficacy of multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training in patients with mild cognitive impairment and mild Alzheimer's disease. Patients who eligible to the inclusion criteria and ineligible to the exclusion criteria will be randomly assigned into three groups by a 1:1:1 ratio. Patients in first arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. Patients in the second arm will receive intervention of exercise and cognitive training. Patients in the third arm will receive regular health advice. We hypothesize that the multi-domain intervention will reduce impairment in the study group compared to the control group during the 2-year intervention period.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Multi-domain intervention group | Experimental | Behavioral: Diet intervention, Behavioral: Exercise, Behavioral: Cognitive trainingPatients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training. |
| Exercise and cognitive training | Experimental | Behavioral: Exercise, Behavioral: Cognitive trainingPatients in this arm will receive the intervention of exercise and cognitive training. |
| Standard health counseling at baseline | No intervention | –Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 60-90 years
- In accordance with the diagnostic criteria for "mild cognitive impairment due to Alzheimer's disease" or "mild Alzheimer's disease" from the National Institutes of Health National Institute on Aging-Alzheimer's Association (NIA-AA) (2011)
- The Hamilton depression rating scale/17 edition (HAMD) total score≤10
- Neurological examination: no obvious signs
- Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability
Key exclusion criteria (10 listed)
- Other causes of cognitive decline: cerebrovascular disease, central nervous system infection, Creutzfeldt-Jakob disease, Huntington's and Parkinson's disease, Creutzfeldt-Jakob disease, traumatic brain dementia, other physical and chemical factors (such as drugs, alcohol, CO), systemic disease (hepatic encephalopathy, pulmonary encephalopathy, etc.), intracranial occupation (a subdural hematoma, brain tumor), the endocrine system disease (thyroid disease, parathyroid disease), and vitamins deficiency or any other causes of dementia
- The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc
- Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium
- There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors.
- Vision or hearing problems that lead to poor performance on cognitive tests
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 |
|---|---|---|
| Diet interventionLow inflammatory-index diet | Behavioural | Multi-domain intervention group |
| ExerciseGuided muscle strength training and stretching exercises | Behavioural | Exercise and cognitive training, Multi-domain intervention group |
| Cognitive trainingCognitive training will be implemented in person | Behavioural | Exercise and cognitive training, Multi-domain intervention group |
Primary outcome
Change from baseline global cognitive function at one year
Time frame: One year
Change from baseline general cognitive performance at one year assessed by Mini-mental state examination (MMSE)
Change from baseline memory at one year
Time frame: One year
Change from baseline verbal memory using the Auditory verbal learning test (AVLT)
Change from baseline visual spatial ability and visual memory at one year
Time frame: One year
Change from baseline visual spatial ability and visual memoryevaluated by the Rey-Osterrieth complex figure test (CFT)
6 secondary outcomes
Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test
Time frame: One year
Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)
Time frame: One year
Changes in structural brain MRI including volume of hippocampus and other specific brain regions
Time frame: One year
Changes in Inflammatory biomarkers
Time frame: One year
Changes in gut microbiota
Time frame: One year
Changes in Metabolic biomarkers
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diet intervention, Exercise and Cognitive training in people with Mild Cognitive Impairment and Mild Dementia, 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 6 inclusion and 10 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 22 Nov 2024. 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 Binyin Li, Dr (021-64370045, lby11917@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline global cognitive function at one year (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Nov 2024.