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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Silkworm pupa powder

    Dietary supplement

    Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months

  • Placebo

    Dietary supplement

    Placebo, 2 sachets (12\*2 g) twice a day, with warm water, before meals, for three months

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Experimental groupExperimental treatment 1 intervention
Group B: Control groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin

Take blood testing and detect hemoglobin levels

Time frame
The 4th 、8th and 12th week after taking Silkworm
2

Albumin

Detect blood albumin levels

Time frame
The 4th 、8th and 12th week after taking Silkworm pupa powder.
3

Serum prealbumin

Detect serum prealbumin levels

Time frame
The 4th 、8th and 12th week after taking Silkworm pupa powder.
4

25-hydroxyvitamin D

Detect blood 25-hydroxyvitamin D levels

Time frame
The 4th 、8th and 12th week after taking Silkworm pupa powder.

Secondary outcomes

1

Mini-mental State Examination(MMSE) Scale

Take the MMSE Scale again

Time frame
The 4th、8th and 12th week after taking placebo.
2

Clinical Dementia Rating(CDR) Scale

Take the CDR Scale again

Time frame
The 4th 、8th and 12th week after taking placebo.
3

Eastern Cooperative Oncology Group Score

Take the ECOG Score again

Time frame
The 4th 、8th and 12th week after taking placebo.
4

Head Magnetic Resonance Scan

Take Head MR again

Time frame
The 4th 、8th and 12th week after taking placebo.

Other outcomes

Sponsors and contacts

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