Actively Recruiting
Silkworm Pupa Powder Improves Dementia.
Led by Zhejiang Provincial Tongde Hospital · Updated on 2025-05-04
300
Participants Needed
1
Research Sites
90 weeks
Total Duration
On this page
Sponsors
Z
Zhejiang Provincial Tongde Hospital
Lead Sponsor
H
Hangzhou Institute of Medicine Chinese Academy of Sciences
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. The main questions it aims to answer are: * Will silkworm pupa powder improve the daily living conditions of patients with Alzheimer's disease? * Will silkworm pupa powder improve the nutritional status and frailty of Alzheimer's disease patients? Researchers will compare silkworm pupa powder with a placebo (a similar substance containing 0.5% silkworm pupa powder) to see if silkworm pupa powder can treat Alzheimer's disease. Participants will: * Take silkworm pupa powder or placebo daily for four months; * Visit the clinic for check-ups and tests every four weeks; * Record their symptoms and various physiological indicators.
CONDITIONS
Official Title
Silkworm Pupa Powder Improves Dementia.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of probable Alzheimer's disease according to NIA-AA criteria with mild, moderate, or severe disease (MMSE score 0-24)
- Biomarker confirmation of Alzheimer's disease pathology (AB2 and tau positivity)
- Age between 50 and 90 years inclusive, with at least primary school education
- Stable doses of approved Alzheimer's disease medications for 12 weeks or treatment-na�EFve
- Hachinski Ischemia Scale score C= 4
- Geriatric Depression Scale-15 score C= 4
- Neuroimaging evidence showing age-related brain changes or cerebral atrophy
- Availability of a stable and reliable caregiver
- Written informed consent from participant or legally authorized representative
- Agreement to provide blood, stool, and urine samples during the study
You will not qualify if you...
- Diagnosis of dementia other than Alzheimer's disease or other central nervous system disorders
- Unstable vital signs with abnormal cardiac, pulmonary, hepatic, renal, or other organ functions
- Low folate or vitamin B12 levels, or dementia caused or worsened by hypothyroidism
- Positive syphilis test
- Comorbid psychiatric disorders
- Long-term alcoholism or substance abuse
- Intolerance or allergy to study medications
- Abnormal cranial MRI findings such as infarctions, hydrocephalus, or brain tumors
- Significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or currently
- Antibiotic use exceeding 10 days within 12 weeks prior to baseline or expected during the study
- Geriatric Depression Scale-15 score greater than 4 at screening
- Any inadequately controlled condition affecting safety or study assessments
- Participation in Alzheimer's disease trials involving novel chemicals within 6 months unless placebo group
- Clinically significant abnormalities in physical exam, vital signs, labs, or ECG requiring further care
- Participation in trials involving monoclonal antibodies, immunoglobulin therapy, or vaccines within 6 months unless placebo group
- Participation in anti-amyloid therapy trials unless placebo group
- Uncontrolled immune disorders requiring immunoglobulins or systemic immunosuppressants during the study
- Uncontrolled bleeding disorders or unstable anticoagulation; anticoagulated participants excluded from CSF assessments
AI-Screening
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Trial Site Locations
Total: 1 location
1
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, China, 310012
Actively Recruiting
Research Team
J
Jiangtao Zhang
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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