AD - Alzheimer's DiseaseADNCT07059871
A Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease.
A study testing Silkworm pupa powder in people with AD - Alzheimer's Disease and Sarcopenia, run by Zhejiang Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- AD - Alzheimer's Disease, Sarcopenia, Asthenia
- What is being tested?
- Silkworm pupa powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 23 Nov 2025to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
- Intolerance or allergy to the drugs used in this study.
- Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within the past 12 months or current diagnosis.
- Antibiotic use: a. Continuous use of antibiotics for >10 days within 12 weeks prior to baseline; b. Anticipated need for antibiotic treatment exceeding 10 days during the study. Any other disease (e.g., cardiac, respiratory, renal, gastrointestinal diseases potentially affecting absorption such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) not adequately controlled and stable, or any condition the investigator believes may affect participant safety or interfere with study assessments.
- Any other clinically significant abnormality in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) that, in the investigator's opinion, warrants further investigation or treatment, or may interfere with study procedures or safety.
- Participants with inadequately controlled hemorrhagic disorders (including platelet count <50 x 10^9/L or International Normalized Ratio [INR] >1.5 for participants not on anticoagulant therapy like warfarin).
- Any other condition deemed by the investigator to make the participant unsuitable for study participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhejiang Hospital
Hangzhou, Zhejiang
Xiaoling Shou, +86-13336153617, shxili@163.com
About this study
Official title: A Prospective, Double-blind, Randomized Controlled Clinical Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease
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?
Read more
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
- AD - Alzheimer's Disease, Sarcopenia, Asthenia
- Being tested
- Silkworm pupa powder, Placebo
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status
- Medical subject headings
- Sarcopenia, Asthenia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silkworm pupa powderDietary supplement
Silkworm pupa powder, 2 times a day, two packets (12*2 g) each time, take with warm water, before meals, for three months
PlaceboDietary supplement
Placebo, 2 sachets (12*2 g) twice a day, with warm water, before meals, for three months
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin
Take blood testing and detect hemoglobin levels
Measured: The 4th 、8th and 12th week after taking Silkworm
Albumin
Detect blood albumin levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Serum prealbumin
Detect serum prealbumin levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
25-hydroxyvitamin D
Detect blood 25-hydroxyvitamin D levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Alkaline phosphatase
Detect blood alkaline phosphatase levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Parathyroid hormone
Detect parathyroid hormone levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Calcitonin
Detect calcitonin levels
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Whole abdominal Computerized tomography (CT) scan
Take the whole abdominal CT scan
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Diagnostic criteria of the 2019 Asian Sarcopenia Working Group
Evaluate sarcopenia again
Measured: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Secondary outcomes (6)
Mini-mental State Examination（MMSE） Scale
Take the MMSE Scale again
Measured: The 4th、8th and 12th week after taking placebo.
Clinical Dementia Rating（CDR） Scale
Take the CDR Scale again
Measured: The 4th 、8th and 12th week after taking placebo.
Eastern Cooperative Oncology Group Score
Take the ECOG Score again
Measured: The 4th 、8th and 12th week after taking placebo.
Head Magnetic Resonance Scan
Take Head MR again
Measured: The 4th 、8th and 12th week after taking placebo.
Amyloid β-protein（Aβ）
Detect the blood Amyloid β-protein levels, include Aβ42、Aβ40、Aβ40/42
Measured: The 4th 、8th and 12th week after taking placebo.
Phosphorylated microtubule-associated protein Tau（P-Tau）
Detect the Phosphorylated microtubule-associated protein Tau levels, include P-tau181、P-tau 217
Measured: The 4th 、8th and 12th week after taking placebo.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start23 Nov 2025
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AD - Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07059871
- Sponsor's protocol ID
- ZJHIRB-2025-095K
- Acronym
- AD
- Status last verified
- May 2025
- First submitted
- 1 Jul 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Our research is in the exploratory stage and it is not yet clear what results will be obtained.
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized Controlled Clinical Study of Silkworm Pupa Powder Intervention in the Nutritional Status of Patients With Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07059871
- Acronym / sponsor ID
- AD / ZJHIRB-2025-095K
- Conditions
- AD - Alzheimer's Disease, Sarcopenia, Asthenia
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zhejiang HospitalUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Dietary Supplement: Silkworm pupa powderSilkworm pupa powder, 2 times a day, two packets (12*2 g) each time, take with warm water, before meals, for three months |
| Control group | Placebo comparator | Dietary Supplement: PlaceboPlacebo, 2 sachets (12*2 g) twice a day, with warm water, before meals, for three months |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Silkworm pupa powderSilkworm pupa powder, 2 times a day, two packets (12*2 g) each time, take with warm water, before meals, for three months | Dietary supplement | Experimental group |
| PlaceboPlacebo, 2 sachets (12*2 g) twice a day, with warm water, before meals, for three months | Dietary supplement | Control group |
Primary outcome
Hemoglobin
Time frame: The 4th 、8th and 12th week after taking Silkworm
Take blood testing and detect hemoglobin levels
Albumin
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect blood albumin levels
Serum prealbumin
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect serum prealbumin levels
25-hydroxyvitamin D
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect blood 25-hydroxyvitamin D levels
Alkaline phosphatase
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect blood alkaline phosphatase levels
Parathyroid hormone
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect parathyroid hormone levels
Calcitonin
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Detect calcitonin levels
Whole abdominal Computerized tomography (CT) scan
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Take the whole abdominal CT scan
Diagnostic criteria of the 2019 Asian Sarcopenia Working Group
Time frame: The 4th 、8th and 12th week after taking Silkworm pupa powder.
Evaluate sarcopenia again
6 secondary outcomes
Mini-mental State Examination（MMSE） Scale
Time frame: The 4th、8th and 12th week after taking placebo.
Clinical Dementia Rating（CDR） Scale
Time frame: The 4th 、8th and 12th week after taking placebo.
Eastern Cooperative Oncology Group Score
Time frame: The 4th 、8th and 12th week after taking placebo.
Head Magnetic Resonance Scan
Time frame: The 4th 、8th and 12th week after taking placebo.
Amyloid β-protein（Aβ）
Time frame: The 4th 、8th and 12th week after taking placebo.
Phosphorylated microtubule-associated protein Tau（P-Tau）
Time frame: The 4th 、8th and 12th week after taking placebo.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided. Our research is in the exploratory stage and it is not yet clear what results will be obtained.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Silkworm pupa powder in people with AD - Alzheimer's Disease and Sarcopenia, run by Zhejiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Song Qiao (+86-13116727887, qiaosongicu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemoglobin (time frame: The 4th 、8th and 12th week after taking Silkworm). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.