A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients with Alzheimer's Disease.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorYanbu Ke

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 dementia caused by AD as determined by the National Institute on Aging and the Alzheimer's Disease Association (NIA-AA) (2024);

Male or menopausal female (no fertility requirement), participants are 50-90 years old (inclusive) with primary school education or above;

The Mini Mental State Examination (MMSE) score for illiteracy is ≤ 17 points, primary school education is ≤ 20 points, secondary school education is ≤ 22 points, and university education is ≤ 23 points; CDR>2.0 points;;

0 points< 40 points ≤ the ADL Rating Scale;

Disqualifiers

Dementia caused by the following reasons: vascular dementia, central nervous system infection (such as AIDS, syphilis, etc.), Huntington's disease and Parkinson's disease, dementia with Lewy bodies, traumatic brain dementia, other physical and chemical factors (such as drug poisoning, alcohol poisoning, carbon monoxide poisoning, etc.), important physical diseases ( Such as hepatic encephalopathy, pulmonary encephalopathy, hypoxic encephalopathy, etc.), intracranial mass lesions (such as subdural hematoma, brain tumors), endocrine system lesions (such as thyroid disease, adrenal gland disease) as well as dementia caused by vitamins or any other cause;

Patients with other autoimmune diseases, such as multiple sclerosis, polymyositis, myasthenia gravis, Guillain-Barré syndrome, ankylosing spondylitis, rheumatoid arthritis, systemic lupus erythematosus, vitiligo, etc.;

Severe renal insufficiency: creatinine clearance rate < 30mL/min (Cockcroft-Gault formula).or other known severe renal insufficiency disease; Severe hepatic impairment: ALT or AST > 10 times the upper limit of normal, or other known liver diseases such as acute and chronic active hepatitis, liver cirrhosis, etc.; During the screening period, patients with acute myocardial infarction or interventional therapy in the past 6 months, and heart failure (patients classified as grade III-IV according to NYHA); Patients with other serious primary diseases of the nervous system, heart, pulmonary, hematopoietic system or endocrine system and psychiatric disorders;

Those who suspect or have a 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

100 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

Click on the lead sponsor to view all of their trials.

Yanbu Ke

Lead sponsor

First People's Hospital of Hangzhou

Sponsor institution

This trial is not recruiting at the moment. You can still explore other options: