About this trial
The goal of this clinical trial is to learn if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients. The main questions it aims to answer are:
* Does silkworm pupa powder evaluate the effectiveness of silkworm pupae in improving sarcopenia, frailty and quality of life in AD patients? * Does silkworm pupa powder improve cognitive function in AD patients?
Researchers will compare silkworm pupa powder to a placebo (a look-alike substance that contains no drug) to see if silkworm pupa powder works to improve the nutritional status of Alzheimer's disease patients.
Participants will:
* Take drug silkworm pupa powder or a placebo every day for 3 months. * Visit the clinic once every 4 weeks for checkups and tests. * Keep a diary of their daily consumption.
Eligibility criteria
Qualifiers
Meet the diagnostic criteria for dementia caused by AD as determined by the National Institute on Aging and the Alzheimer's Disease Association (NIA-AA) (2024);
Male or menopausal female (no fertility requirement), participants are 50-90 years old (inclusive) with primary school education or above;
The Mini Mental State Examination (MMSE) score for illiteracy is ≤ 17 points, primary school education is ≤ 20 points, secondary school education is ≤ 22 points, and university education is ≤ 23 points; CDR>2.0 points;;
0 points< 40 points ≤ the ADL Rating Scale;
Disqualifiers
Dementia caused by the following reasons: vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic brain dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), important physical diseases ( Such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), intracranial mass lesions (such as subdural hematoma, brain tumors), endocrine system lesions (such as thyroid disease, adrenal gland disease) as well as dementia caused by vitamins or any other cause;
Patients with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.;
Severe renal insufficiency: creatinine clearance rate < 30mL/min (Cockcroft-Gault formula).or other known severe renal insufficiency disease; Severe hepatic impairment: ALT or AST > 10 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, liver cirrhosis, etc.; During the screening period, patients with acute myocardial infarction or interventional therapy in the past 6 months, and heart failure (patients classified as grade III-IV according to NYHA); Patients with other serious primary diseases of the nervous system, heart, pulmonary, hematopoietic system or endocrine system and psychiatric disorders;
Those who suspect or have a history of alcohol or drug abuse;
Trial design
Treatments tested in this trial
- Silkworm pupa powder
- Placebo
Treatment groups
Sponsors and collaborators
Yanbu Ke
Lead sponsor
First People's Hospital of Hangzhou
Sponsor institution