A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorZhejiang Hospital
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 probable dementia due to Alzheimer's disease (AD) as defined by the National Institute on Aging and Alzheimer's Association (NIA-AA) (2024).
Male or postmenopausal female (without childbearing potential). Participants aged 50-90 years (inclusive), with an education level of primary school or higher.
Mini-Mental State Examination (MMSE) score: ≤17 for illiterate, ≤20 for primary school education, ≤22 for secondary school education, ≤23 for university education; Clinical Dementia Rating (CDR) global score > 2.0.
Activities of Daily Living (ADL) Scale score >0 and ≤40.
Disqualifiers
Dementia caused by: vascular dementia; CNS infections (e.g., AIDS, syphilis); Huntington's disease; Parkinson's disease; Lewy body dementia; traumatic brain injury-related dementia; other physical/chemical factors (e.g., drug intoxication, alcohol intoxication, carbon monoxide poisoning); significant systemic diseases (e.g., hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy); intracranial space-occupying lesions (e.g., subdural hematoma, brain tumor); endocrine disorders (e.g., thyroid disease, adrenal disease); vitamin deficiencies; or dementia due to any other cause.
Co-existing autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.
Severe renal impairment: Creatinine clearance <30 mL/min (Cockcroft-Gault formula) or other known severe renal disease; Severe hepatic impairment: ALT or AST >10 times the upper limit of normal (ULN), or other known liver diseases such as acute/chronic active hepatitis, cirrhosis, etc.; Acute myocardial infarction or interventional cardiac procedure within 6 months prior to screening; Heart failure (NYHA Class III-IV); Patients with other severe primary neurological, cardiac, pulmonary, hematopoietic, endocrine system diseases, or psychiatric disorders.
Suspected or confirmed history of alcohol or drug abuse.
Trial design
Treatments tested in this trial
- Silkworm pupa powder
- Placebo
Treatment groups
200 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov