Actively Recruiting
A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease.
Led by Zhejiang Hospital · Updated on 2026-01-02
200
Participants Needed
1
Research Sites
57 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Meet diagnostic criteria for probable Alzheimer's disease dementia per NIA-AA (2024).
- Male or postmenopausal female aged 50 to 90 years with at least primary school education.
- Mini-Mental State Examination (MMSE) score appropriate for education level (≤17 illiterate, ≤20 primary school, ≤22 secondary school, ≤23 university).
- Clinical Dementia Rating (CDR) global score > 2.0.
- Activities of Daily Living (ADL) Scale score between 1 and 40.
- Nutritional Risk Screening (NRS 2002) score ≥ 3 at screening.
- Good general health with ECOG Performance Status score ≤ 3.
- Stable dose of approved Alzheimer's treatments for at least 12 weeks prior or treatment-naïve.
- Availability of a stable, reliable caregiver.
- Voluntary informed consent and willingness to comply with study procedures.
- Agree to provide blood, stool, and urine samples for biomarker analysis.
You will not qualify if you...
- Dementia caused by other conditions like vascular dementia, infections, Parkinson's disease, Lewy body dementia, traumatic brain injury, or other causes.
- Autoimmune diseases such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, or vitiligo.
- Severe renal or hepatic impairment, recent heart attack or cardiac procedure, heart failure (NYHA Class III-IV), or other severe systemic diseases.
- History or suspicion of alcohol or drug abuse.
- Life expectancy less than 3 months.
- Pregnant or lactating women; participants of childbearing potential unwilling to use contraception.
- Allergy to investigational product components.
- Participation in another clinical trial within 30 days.
- Severe physical or psychiatric illness or lab abnormalities increasing risk or interfering with study.
- MMSE score greater than 26.
- ADL Scale score greater than 40.
- Significant elevation of tumor markers or history of malignancy.
- High suicide risk.
- Chronic substance abuse affecting evaluation.
- Intolerance or allergy to study drugs.
- Clinically significant cardiovascular or cerebrovascular disease within past 12 months.
- Extensive antibiotic use before or anticipated during study.
- Any other uncontrolled or unstable disease affecting safety or assessments.
- Significant hemorrhagic disorders or coagulation abnormalities.
- Any condition deemed unsuitable by investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Zhejiang Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
S
Song Qiao
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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