Health TrialsbyHealthPanel

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

ConditionsMild Cognitive ImpairmentMild Dementia
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60-90
SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Diet intervention

    Behavioral

    Low inflammatory-index diet

  • Exercise

    Behavioral

    Guided muscle strength training and stretching exercises

  • Cognitive training

    Behavioral

    Cognitive training will be implemented in person

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Multi-domain intervention groupExperimental treatment 3 interventions
Group B: Exercise and cognitive trainingExperimental treatment 2 interventions
Group C: Standard health counseling at baselineNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
One year
2

Change from baseline memory at one year

Change from baseline verbal memory using the Auditory verbal learning test (AVLT)

Time frame
One year
3

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)

Time frame
One year

Secondary outcomes

1

Changes in cognition assessed by Clock drawing test, Symbol-digit test, Trail making test, Boston naming test and Language fluency test

Executive function

Time frame
One year
2

Changes in hippocampus related neural circuit-specific resting-state connectivity (FC)

Neural connectivity by functional MRI

Time frame
One year
3

Changes in structural brain MRI including volume of hippocampus and other specific brain regions

Brain structure by MRI

Time frame
One year
4

Changes in Inflammatory biomarkers

Serum interleukins and tumor necrosis factors

Time frame
One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Shanghai Sinopharm Nursing Care Center

Collaborator

Source ClinicalTrials.gov
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