Actively Recruiting
Study of Silkworm Pupa Powder to Improve Nutritional Status in Alzheimer's Disease Patients
Led by Zhejiang Hospital · Updated on 2026-01-02
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether silkworm pupa powder can improve the nutritional status, sarcopenia, frailty, quality of life, and cognitive function in patients with Alzheimer's disease. This prospective, double-blind, randomized controlled clinical study aims to compare the effects of silkworm pupa powder against a placebo in people aged 50 to 90 years who meet specific Alzheimer's disease diagnostic criteria. Participants will take either silkworm pupa powder or a placebo twice daily with warm water before meals for three months. Each dose consists of two packets (12 grams each) taken two times a day. The study will include checkups and tests every four weeks during the treatment period to monitor effects and safety. During the study, participants will visit the clinic every four weeks for assessments including blood tests measuring hemoglobin, albumin, serum prealbumin, vitamin D, alkaline phosphatase, parathyroid hormone, and calcitonin. Imaging tests such as abdominal CT scans and head MRI will also be performed. Researchers will evaluate sarcopenia using diagnostic criteria and cognitive function with tools like the Mini-Mental State Examination and Clinical Dementia Rating. Participants will keep a daily diary of their consumption, and safety and health will be closely monitored throughout the trial lasting at least 12 weeks.
CONDITIONS
Brief 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 according to NIA-AA (2024)
- Male or postmenopausal female aged 50 to 90 years with at least primary school education
- Mini-Mental State Examination (MMSE) score 17 or lower for illiterate, 20 or lower for primary school, 22 or lower for secondary school, 23 or lower for university education
- Clinical Dementia Rating (CDR) global score greater than 2.0
- Activities of Daily Living (ADL) Scale score between 1 and 40
- Nutritional Risk Screening (NRS 2002) score of 3 or higher at screening
- Eastern Cooperative Oncology Group (ECOG) Performance Status score 3 or lower
- Stable dose of approved Alzheimer's treatments for at least 12 weeks or treatment-naive
- Stable, reliable caregiver available
- Ability and willingness to complete all trial procedures and provide informed consent
- Agree to provide blood, stool, and urine samples for biomarker analysis
You will not qualify if you...
- Dementia caused by vascular, infection, Huntington's, Parkinson's, Lewy body, traumatic brain injury, or other causes
- Co-existing autoimmune diseases like multiple sclerosis, rheumatoid arthritis, lupus, etc.
- Severe kidney or liver impairment, recent heart attack or cardiac procedures, severe heart failure
- Severe neurological, cardiac, pulmonary, hematopoietic, endocrine, or psychiatric disorders
- History of alcohol or drug abuse
- Life expectancy less than 3 months
- Pregnant or lactating women; participants with childbearing potential not using contraception
- Allergy or intolerance to study drugs
- Participation in another clinical trial within 30 days
- Clinically significant psychiatric disorders or symptoms
- MMSE score above 26
- ADL Scale score above 40
- Elevated tumor markers or history of malignancy
- Significant risk of suicide
- Antibiotic use exceeding specified limits before or during study
- Uncontrolled chronic diseases affecting safety or assessments
- Abnormalities in physical exams, labs, or ECG judged unsafe
- Inadequately controlled bleeding disorders
- Any other condition deemed unsuitable by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants take silkworm pupa powder or placebo twice daily before meals to improve nutritional status.
Visits at the 4th, 8th, and 12th week during treatment
Trial Site Locations
Total: 1 location
1
Zhejiang Hospital
Hangzhou, Zhejiang, China
Actively Recruiting
Research Team
S
Song Qiao
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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