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

NCT07059871 | Recruiting DMC

• 1 other identifier: ZJHIRB-2025-095K
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; AD - Alzheimer's Disease; Asthenia

Keywords

Alzheimer Disease; Sarcopenia; asthenia; nutritional status

Outcome Measures

Primary Outcomes (9)

• Hemoglobin

  Take blood testing and detect hemoglobin levels

  The 4th 、8th and 12th week after taking Silkworm

• Albumin

  Detect blood albumin levels

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

• Serum prealbumin

  Detect serum prealbumin levels

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

• 25-hydroxyvitamin D

  Detect blood 25-hydroxyvitamin D levels

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

• Alkaline phosphatase

  Detect blood alkaline phosphatase levels

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

• Parathyroid hormone

  Detect parathyroid hormone levels

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

• Calcitonin

  Detect calcitonin levels

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

• Whole abdominal Computerized tomography (CT) scan

  Take the whole abdominal CT scan

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

• Diagnostic criteria of the 2019 Asian Sarcopenia Working Group

  Evaluate sarcopenia again

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

Secondary Outcomes (6)

• Mini-mental State Examination（MMSE） Scale

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

• Clinical Dementia Rating（CDR） Scale

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

• Eastern Cooperative Oncology Group Score

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

• Head Magnetic Resonance Scan

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

• Amyloid β-protein（Aβ）

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

Study Arms (2)

Experimental group

EXPERIMENTAL

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

Dietary Supplement: Silkworm pupa powder

Control group

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

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

Experimental group

Placebo DIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

• Age: 50 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Nutritional Risk Screening (NRS 2002) score ≥3 at screening/enrollment.
• Good general health status, Eastern Cooperative Oncology Group (ECOG) Performance Status score ≤3.
• If currently receiving approved AD treatments (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), must be on a stable dose for at least 12 weeks prior to baseline, with stable cognitive assessment scores. Treatment-naïve participants for AD are eligible. Unless otherwise specified, all other permitted concomitant medications (non-AD related) must be stable for at least 4 weeks prior to baseline.
• Availability of a stable, reliable caregiver confirmed by the investigator.
• Voluntarily participate in the clinical study, fully understand and be informed about the study, and sign the Informed Consent Form (ICF); willing and able to comply with and complete all trial procedures. If the participant, in the investigator's judgment, lacks capacity to consent, consent must be obtained according to local laws, regulations, and customs (or signed by the patient's caregiver under the authorization of the patient's legal guardian). Agrees to provide peripheral blood, stool, and urine samples for biomarker analysis during the study.

You may not qualify if:

• 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.
• Life expectancy ≤3 months.
• Pregnant or lactating women. Participants of childbearing potential (including male participants engaging in heterosexual intercourse and their female partners of childbearing potential) planning pregnancy or unwilling to use effective contraception from screening initiation until 3 months after discontinuation of the study drug.
• Known allergy/hypersensitivity to any component of the investigational product(s).
• Participation in another investigational drug trial within 30 days prior to screening or current participation in any other clinical trial.
• Presence of any other severe physical or psychiatric illness or laboratory abnormality that may increase the risk associated with study participation or, in the investigator's judgment, makes the patient unsuitable for the study.
• Clinically significant psychiatric disorders or severe psychiatric symptoms.
• MMSE score \>26.
• ADL Scale score \>40.
• Clinically significant elevation of tumor markers, history of malignancy, or patients with tumors of undetermined nature.
• Significant risk of suicide.
• Chronic alcohol abuse or substance abuse that may interfere with efficacy evaluation.

Sponsors & Collaborators

• Zhejiang Hospital: lead

Study Sites (1)

Zhejiang Hospital

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Asthenia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Central Study Contacts

Song Qiao

CONTACT

+86-13116727887; qiaosongicu@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2025
• First Posted: July 11, 2025
• Study Start: November 23, 2025
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: January 2, 2026

Record last verified: 2025-05

Locations

CN (1)