Shanghai Non-pharmacological Intervention for Mild Cognitive Impairment and Mild Alzheimer's Disease

NCT ID: NCT05887674

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-05-11

Study Completion Date

2026-08-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Mild Cognitive Impairment Mild Dementia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multi-domain intervention group

Patients in this arm will receive multi-domain life-style intervention including low inflammatory-index diet, exercise, and cognitive training.

Group Type EXPERIMENTAL

Diet intervention

Intervention Type BEHAVIORAL

Low inflammatory-index diet

Exercise

Intervention Type BEHAVIORAL

Guided muscle strength training and stretching exercises

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training will be implemented in person

Exercise and cognitive training

Patients in this arm will receive the intervention of exercise and cognitive training.

Group Type EXPERIMENTAL

Exercise

Intervention Type BEHAVIORAL

Guided muscle strength training and stretching exercises

Cognitive training

Intervention Type BEHAVIORAL

Cognitive training will be implemented in person

Standard health counseling at baseline

Patients in this arm will have their habitual diet and life style. No particular intervention or consultation would be provided.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Diet intervention

Low inflammatory-index diet

Intervention Type BEHAVIORAL

Exercise

Guided muscle strength training and stretching exercises

Intervention Type BEHAVIORAL

Cognitive training

Cognitive training will be implemented in person

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Aged 60-90 years
2. 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)
3. The Hamilton depression rating scale/17 edition (HAMD) total score≤10
4. Neurological examination: no obvious signs
5. Education: primary school (grade 6) or above and capacity to complete tests for cognitive ability
6. Capacity to give consent

Exclusion Criteria

1. 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
2. The history of nervous system diseases, including stroke, optic myelitis, Parkinson's disease, epilepsy, etc
3. Psychiatric patients, including schizophrenia or other mental illnesses, bipolar disorder, major depression, or delirium
4. There are unstable or serious heart, lung, liver, kidney, endocrine, and hematopoietic system diseases, or Poor prognosis because of malignant diseases such as tumors.
5. Vision or hearing problems that lead to poor performance on cognitive tests
6. Two years history of severe alcoholism, and drug abuse
7. Participants who participated in any other trial 30 days prior to their screening visit
8. Contraindication of MRI scanning
9. Special requirements for diet, e.g., allergy to common food or on a special diet due to medical needs
10. Participants who cannot be followed for at least 6 months (due to a health situation or migration)
Minimum Eligible Age

60 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Shanghai Sinopharm Nursing Care Center

UNKNOWN

Sponsor Role collaborator

Ruijin Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Ruijin Hospital affiliated to Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Binyin Li, Dr

Role: CONTACT

021-64370045

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Binyin Li, Dr

Role: primary

86-13681884221

Xiaomeng Xu, Dr

Role: backup

86-021-64454473

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RJNeuroBank-SIM2

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.