Alzheimer Disease(AD)NCT06898476
Silkworm Pupa Powder Improves Dementia.
A study testing Silkworm pupa powder in people with Alzheimer Disease(AD) and Sarcopenia, run by Zhejiang Provincial Tongde Hospital at 1 site in China.
Trial summary
The purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- 10 Apr 2025to 31 Dec 2027
- 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
- Diagnosis of probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, with disease severity classified as mild, moderate, or severe (i.e., Mini-Mental State Examination [MMSE] total score between 0 and 24 points [inclusive] at screening and baseline).
- Confirmation of AD pathology per the 2024 revised AD diagnostic criteria (biomarker-defined AD with both Aβ and tau positivity):
- Aβ positivity: Plasma Aβ42/40 ratio ≤0.08 or amyloid-PET positivity (SUVR ≥1.1).
- Tau positivity: Plasma p-tau217 ≥2.5 pg/mL or CSF p-tau181/Aβ42 ratio ≥0.02.
- Age: 50 to 90 years of age (inclusive), with at least a primary school education. Both males and females are eligible.
- Stable medication use: If receiving approved AD therapies (e.g., acetylcholinesterase inhibitors, GV-971, NMDA receptor antagonists), doses must remain stable for ≥12 weeks prior to baseline. Treatment-naïve participants are also eligible. All other non-AD-related permitted concomitant medications must remain stable for ≥4 weeks prior to baseline unless otherwise specified.
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- Hachinski Ischemia Scale (HIS) total score ≤4.
- Geriatric Depression Scale-15 (GDS-15) total score ≤4.
- Neuroimaging evidence: Screening CT/MRI showing age-related brain changes or cerebral atrophy.
- Caregiver availability: Participant has a stable and reliable caregiver, as confirmed by the investigator.
- Informed consent: Written informed consent must be provided by the participant or, if the participant lacks decision-making capacity, by a legally authorized representative (in accordance with local laws, regulations, and customs). Participants agree to provide peripheral blood, stool, and urine samples during the study for biomarker analysis.
Who cannot join
- Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders.
- Unstable vital signs accompanied by abnormalities in cardiac, pulmonary, hepatic, renal, or other organ functions.
- Abnormally low folate and/or vitamin B12 levels, or evidence that hypothyroidism has caused or exacerbated the participant's dementia. Participants with abnormal syphilis test results.
- Patients with comorbid psychiatric disorders.
- Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.
- Participants with intolerance or allergy to the study medications.
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- Abnormalities detected on cranial MRI, including ischemic or hemorrhagic infarctions, hydrocephalus, or brain tumors.
- Diagnosis of clinically significant cardiovascular or cerebrovascular disease requiring treatment within 12 months or at present.
- Antibiotic use:
- Continuous antibiotic use for more than 10 days within 12 weeks prior to baseline.
- Anticipated need for antibiotic treatment exceeding 10 days during the study.
- Geriatric Depression Scale-15 (GDS-15) score >4 at screening.
- Any other inadequately controlled condition (e.g., cardiac, respiratory, renal, or gastrointestinal disorders affecting absorption, such as gastric cancer, gastric bypass surgery, or recurrent diarrhea) that may jeopardize participant safety or interfere with study assessments, as judged by the investigator.
- Participation in any clinical trial involving novel chemical entities for Alzheimer's disease (AD) within 6 months prior to screening, unless confirmed to have been in the placebo group.
- Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures/safety.
- Participation in clinical trials involving therapeutic monoclonal antibodies, antibody-derived proteins, immunoglobulin therapy, or vaccines within 6 months prior to screening, unless confirmed to have been in the placebo group.
- Participation in clinical trials involving anti-amyloid therapies (including monoclonal antibodies or BACE inhibitors), unless confirmed to have received only placebo.
- Uncontrolled immune disorders requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives), systemic immunosuppressants, or plasmapheresis during the study.
- Participants with uncontrolled bleeding disorders, including platelet count <50,000 or INR >1.5 (for those not on anticoagulants, e.g., warfarin). Participants on anticoagulants must have optimized and stable dosing for ≥4 weeks prior to screening. Anticoagulated participants are excluded from cerebrospinal fluid (CSF) assessments.
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
Tongde Hospital of Zhejiang Province
Hangzhou, Zhejiang, 310012
Jiangtao Zhang, Phd, 8618969125501, 18969125501@163.com
Yihua Jiang, bachelor, 8613819189045, 917547557@qq.com
About this study
Official title: A Prospective, Double-Blind, Randomized Controlled Trial Evaluating Silkworm Pupa Powder Versus Placebo in Improving Alzheimer's Disease Among Patients
The purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. The main questions it aims to answer are:
- Will silkworm pupa powder improve the daily living conditions of patients with Alzheimer's disease?
- Will silkworm pupa powder improve the nutritional status and frailty of Alzheimer's disease patients?
Read more
Researchers will compare silkworm pupa powder with a placebo (a similar substance containing 0.5% silkworm pupa powder) to see if silkworm pupa powder can treat Alzheimer's disease.
Participants will:
- Take silkworm pupa powder or placebo daily for four months;
- Visit the clinic for check-ups and tests every four weeks;
- Record their symptoms and various physiological indicators.
- Conditions
- Alzheimer Disease(AD), Sarcopenia, Asthenia
- Being tested
- Silkworm pupa powder, Placebo
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status, frailty state
- 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.
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
The ADAS-Cog is a tool designed to assess the severity of cognitive impairment in patients with Alzheimer's disease (AD). It consists of 12 items that evaluate multiple cognitive domains, including memory, orientation, language, praxis (practical ability), attention, and others. Through a series of standardized cognitive tasks, it measures the severity of AD-related cognitive symptoms and tracks changes in response to treatment. Higher total scores indicate more severe cognitive impairment.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm
Frailty indicators
This study employs serum 25-hydroxyvitamin D concentration as the central biomarker for frailty assessment. The selection is predicated on vitamin D's pivotal role in preserving musculoskeletal function and neuroprotective mechanisms, coupled with established evidence that suboptimal 25-hydroxyvitamin D levels exhibit significant correlations with geriatric frailty syndrome and cognitive decline. Through quantitative analysis via high-precision mass spectrometry, dynamic monitoring of vitamin D status alterations pre- and post-intervention will be conducted. Further investigation will elucidate its associations with frailty phenotypes (e.g., grip strength, gait speed) and dementia progression pathways.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Frailty indicators
Plasma D-dimer concentration has been incorporated into the core biomarker panel for frailty assessment.Change in plasma D-dimer levels from baseline to 12 months, measured by immunoassay, to evaluate its association with disease progression in Alzheimer's disease
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Secondary outcomes (2)
Cognitive and Global Functional Assessment:
The combined evaluation of cognitive decline and global clinical status in Alzheimer's disease (AD) will be assessed using:
Clinician's Interview-Based Impression of Change plus caregiver input (CIBIC-plus):
A semi-structured clinician-rated scale capturing global changes in cognition, function, and behavior, incorporating caregiver perspectives.
Mini-Mental State Examination (MMSE):
A validated 30-point cognitive screening tool evaluating domains including orientation, memory, attention, language, and visuospatial abilities.
Rationale:
The dual assessment leverages:
CIBIC-plus for holistic, clinician-judged disease progression (anchored to baseline severity).
MMSE for quantifiable tracking of specific cognitive deficits. This approach aligns with FDA guidelines for multidimensional evaluation of therapeutic efficacy in AD trials (e.g., 21 CFR 314.510).
Statistical Analysis:
Changes in CIBIC-plus (ordinal scale) and MMSE scores (continuous scale) will be analyzed longitudinally,
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI).
The nutritional index is evaluated using the Third Lumbar Skeletal Muscle Index (L3-SMI): A single cross-sectional image of L3 is obtained through CT scanning, and skeletal muscles in the image are identified and quantified using a HU threshold of -29 to 150. The total muscle area at this level is calculated using 3D Slicer software, and then divided by the square of the height (m^2) to obtain the Third Lumbar Skeletal Muscle Index (L3-SMI).
Time Frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start10 Apr 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang Provincial Tongde Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Responsible party
- Principal investigator, Jiangtao Zhang, Zhejiang Provincial Tongde Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898476
- Sponsor's protocol ID
- Jiangtao Zhang
- Status last verified
- Jun 2026
- First submitted
- 21 Mar 2025
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-Blind, Randomized Controlled Trial Evaluating Silkworm Pupa Powder Versus Placebo in Improving Alzheimer's Disease Among Patients
- ClinicalTrials.gov ID
- NCT06898476
- Acronym / sponsor ID
- Jiangtao Zhang
- Conditions
- Alzheimer Disease(AD), Sarcopenia, Asthenia
- Keywords
- Alzheimer Disease, Sarcopenia, asthenia, nutritional status, frailty state
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zhejiang Provincial Tongde HospitalUniversity, hospital or other
- Collaborators
- Hangzhou Institute of Medicine (HIM), Chinese Academy of Sciences
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 27 Mar 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 purpose of this clinical trial is to determine whether silkworm pupa powder is effective in treating Alzheimer's disease. It will also investigate whether silkworm pupa powder can improve the nutritional and frailty status of patients with Dementia. The main questions it aims to answer are:
- Will silkworm pupa powder improve the daily living conditions of patients with Alzheimer's disease?
- Will silkworm pupa powder improve the nutritional status and frailty of Alzheimer's disease patients?
Researchers will compare silkworm pupa powder with a placebo (a similar substance containing 0.5% silkworm pupa powder) to see if silkworm pupa powder can treat Alzheimer's disease.
Participants will:
- Take silkworm pupa powder or placebo daily for four months;
- Visit the clinic for check-ups and tests every four weeks;
- Record their symptoms and various physiological indicators.
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 (11 listed)
- Diagnosis of probable Alzheimer's disease (AD) according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria, with disease severity classified as mild, moderate, or severe (i.e., Mini-Mental State Examination [MMSE] total score between 0 and 24 points [inclusive] at screening and baseline).
- Confirmation of AD pathology per the 2024 revised AD diagnostic criteria (biomarker-defined AD with both Aβ and tau positivity):
- Aβ positivity: Plasma Aβ42/40 ratio ≤0.08 or amyloid-PET positivity (SUVR ≥1.1).
- Tau positivity: Plasma p-tau217 ≥2.5 pg/mL or CSF p-tau181/Aβ42 ratio ≥0.02.
- Age: 50 to 90 years of age (inclusive), with at least a primary school education. Both males and females are eligible.
Key exclusion criteria (19 listed)
- Diagnosis of dementia other than Alzheimer's disease (AD) or other central nervous system disorders.
- Unstable vital signs accompanied by abnormalities in cardiac, pulmonary, hepatic, renal, or other organ functions.
- Abnormally low folate and/or vitamin B12 levels, or evidence that hypothyroidism has caused or exacerbated the participant's dementia. Participants with abnormal syphilis test results.
- Patients with comorbid psychiatric disorders.
- Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.
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
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm
The ADAS-Cog is a tool designed to assess the severity of cognitive impairment in patients with Alzheimer's disease (AD). It consists of 12 items that evaluate multiple cognitive domains, including memory, orientation, language, praxis (practical ability), attention, and others. Through a series of standardized cognitive tasks, it measures the severity of AD-related cognitive symptoms and tracks changes in response to treatment. Higher total scores indicate more severe cognitive impairment.
Frailty indicators
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
This study employs serum 25-hydroxyvitamin D concentration as the central biomarker for frailty assessment. The selection is predicated on vitamin D's pivotal role in preserving musculoskeletal function and neuroprotective mechanisms, coupled with established evidence that suboptimal 25-hydroxyvitamin D levels exhibit significant correlations with geriatric frailty syndrome and cognitive decline. Through quantitative analysis via high-precision mass spectrometry, dynamic monitoring of vitamin D status alterations pre- and post-intervention will be conducted. Further investigation will elucidate its associations with frailty phenotypes (e.g., grip strength, gait speed) and dementia progression pathways.
Frailty indicators
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Plasma D-dimer concentration has been incorporated into the core biomarker panel for frailty assessment.Change in plasma D-dimer levels from baseline to 12 months, measured by immunoassay, to evaluate its association with disease progression in Alzheimer's disease
2 secondary outcomes
Cognitive and Global Functional Assessment:
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
Assessing patient nutritional improvement using Third Lumbar Skeletal Muscle Index (L3-SMI).
Time frame: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder.
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 8 Jun 2026.
- Individual participant dataSharing planned: Undecided
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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 Zhejiang Provincial Tongde 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 11 inclusion and 19 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 8 Jun 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 Jiangtao Zhang (+8618969125501, 18969125501@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) (time frame: The 0th、 4th 、8th and 12th week after taking Silkworm). The study lists 3 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 8 Jun 2026.