Alzheimer Disease (AD)ADNCT06770309
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 Alzheimer Disease (AD) and Sarcopenia, run by Yanbu Ke 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
- Alzheimer Disease (AD), Sarcopenia, Asthenia
- What is being tested?
- Silkworm pupa powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 2 Jan 2025to 31 Dec 2025
- 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 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;
- At the time of screening and enrollment, there was a nutritional risk score of ≥3 points (according to the NRS2002 Nutritional Risk Screening Form);
- In good general condition, ECOG score ≤ 3 points;
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- If you are receiving approved Alzheimer's disease treatment, such as acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists, you must maintain a stable dose for at least 12 weeks before baseline, and the cognitive evaluation scale is stable. Participants who have not been treated for Alzheimer's disease may be enrolled. Unless otherwise noted, participants must maintain a stable dose of all other (i.e., non-Alzheimer's disease-related) permitted concomitant medications for at least 4 weeks prior to baseline;
- The investigator confirms that the subject has a stable and reliable caregiver;
- You voluntarily participate in this clinical research, fully understand and be informed about the study, and sign the informed consent form (ICF).； Willing to follow and able to complete all trial procedures. If the participant lacks the capacity to consent in the opinion of the investigator, the participant's consent shall be obtained as required by local laws, regulations, and customs. (or signed by the patient's caregiver with the authorization of the patient's guardian) during the study to agree to provide peripheral blood, feces, urine, samples for biomarker analysis.
Who cannot join
- 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;
- Estimated survival ≤ 3 months;
- Pregnant women or lactating women, subjects of childbearing age (including male subjects with heterosexual intercourse and their female partners of childbearing potential) who have pregnancy plans or are unwilling to take effective contraceptive measures from the beginning of screening to 3 months after discontinuation;
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- Those who are allergic to the ingredients of known test supplies
- Participated in other drug clinical trials within 30 days before screening, or are participating in other clinical trials;
- Patients with other serious physical or psychiatric diseases or laboratory abnormalities that may increase the risk of participating in the study and who are considered by the investigator to be unsuitable for participating in this study
- Clinically severe mental disorder or psychiatric symptoms;
- Mini-Mental State Assessment Scale (MMSE) score > 26 points;
- Activity of daily living ability (ADL) rating scale > 40 points
- Patients with abnormally elevated tumor markers or a history of tumor or no clear tumor;
- Those who are at serious risk of suicide;
- Patients who are intolerant or allergic to the drugs used in this study;
- Clinically significant cardiovascular or cerebrovascular disease requiring treatment within 1 6 months or current diagnosis within 2 months;
- Use of antibiotics: a. Use of antibiotics for more than 10 consecutive days in the 12 weeks prior to baseline; b. Subjects are expected to be treated with antibiotics for more than 10 days; Any other medical condition (e.g., cardiac, respiratory, renal disease, gastrointestinal disease that may affect absorption, such as gastric cancer, gastric bypass, or recurrent diarrhea) that is not stable and adequately controlled, or that, in the opinion of the investigator, may affect the safety of the participant or interfere with study assessments;
- Any other clinically significant abnormality in physical examination, vital signs, laboratory tests, or ECG that, in the opinion of the investigator, requires further investigation or treatment, or may interfere with study procedures or safety;
- Participants with bleeding disorders that are not adequately controlled (including platelet count< 50*10^9/L or international normalized ratio [INR]>1.5 for participants who did not receive anticoagulation therapy, e.g., warfarin);
- Other circumstances that the researcher deems inappropriate to participate in this study.
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
Hangzhou First People's Hospital
Hangzhou, Zhejiang, 310022
Gaoyi Yang, +86-057156739127, keller416@126.com
Gaoyi Yang
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
- Alzheimer Disease (AD), Sarcopenia, Asthenia
- Being tested
- Silkworm pupa powder, Placebo
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status
- Medical subject headings
- Alzheimer Disease, Sarcopenia, Asthenia
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 posted13 Jan 2025
- Study start2 Jan 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease (AD)Studies 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanbu Ke
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanbu Ke, First People's Hospital of Hangzhou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06770309
- Sponsor's protocol ID
- syyycanyongfen
- Acronym
- AD
- Status last verified
- Dec 2024
- First submitted
- 29 Dec 2024
- Last updated
- 13 Jan 2025
- 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 13 Jan 2025. 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
- NCT06770309
- Acronym / sponsor ID
- AD / syyycanyongfen
- Conditions
- Alzheimer Disease (AD), Sarcopenia, Asthenia
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Yanbu KeUniversity, hospital or other
- Study start
- 2 Jan 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jan 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 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;
- At the time of screening and enrollment, there was a nutritional risk score of ≥3 points (according to the NRS2002 Nutritional Risk Screening Form);
Key exclusion criteria (20 listed)
- 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;
- Estimated survival ≤ 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 13 Jan 2025.
- 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 Alzheimer Disease (AD) and Sarcopenia, run by Yanbu Ke 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 20 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: opening soon, as of the sponsor's last update on 13 Jan 2025. 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 Gaoyi Yang (+86057156739127, keller416@126.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 13 Jan 2025.