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Alzheimer DiseaseNCT07638449

Silkworm Pupa Powder Improves Alzheimer's Disease

A study testing Silkworm pupa powder in people with Alzheimer Disease and Sarcopenia, run by Zhejiang Provincial Tongde Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to learn if silkworm pupa powder works to treat Alzheimer's disease in patients. It will also learn about the safety of silkworm pupa powder, and its effect on patients' nutritional and frailty status. Read more about this study

Who is it for?
Ages 50 to 90 years
Conditions the study is for
Alzheimer Disease, Sarcopenia, Asthenia
What is being tested?
Silkworm pupa powder
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jun 2026to 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. Disease severity is classified as mild to moderate, defined as a Mini-Mental State Examination (MMSE) total score of 0-24 points, inclusive, at both 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 (inclusive), male or female, with at least a primary school education.
  • 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 permitted non-AD related 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.
  • Participant has a stable and reliable caregiver, as confirmed by the investigator.
  • 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 must 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. Abnormal syphilis test results.
  • Comorbid psychiatric disorders.
  • Long-term alcoholism or substance abuse that may compromise the evaluation of treatment efficacy.
  • Intolerance or allergy to the study medication (silkworm pupa powder).
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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.
  • 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.
  • Administration of any new chemical entity in an AD clinical study within 6 months prior to screening.
  • Clinically significant abnormalities in physical examination, vital signs, laboratory tests, or electrocardiogram (ECG) requiring further investigation, treatment, or posing risks to study procedures or safety.
  • Participation in a clinical study involving therapeutic monoclonal antibodies, antibody-derived proteins, immunoglobulin therapy, or vaccines within 6 months prior to screening.
  • Participation in a clinical study involving any anti-amyloid therapies (including any monoclonal antibody therapy and any BACE inhibitor therapy).
  • Any inadequately controlled immune disorder, or immune disease requiring treatment with immunoglobulins, systemic monoclonal antibodies (or derivatives), systemic immunosuppressants, or plasmapheresis during the study.
  • Inadequately controlled bleeding disorders (including platelet count <50,000 or INR >1.5 for participants not on anticoagulants, e.g., warfarin). Participants on anticoagulants must have their anticoagulation status optimized and receive a stable dose within 4 weeks prior to screening. Participants receiving anticoagulant therapy must not participate in cerebrospinal fluid (CSF) assessments.
  • Participation in another concurrent silkworm pupa powder intervention study conducted at the same study center.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Jiangtao Zhang contact

+8618969125501

18969125501@163.com

China1 site
  • Tongde Hospital of Zhejiang Province

    Hangzhou, Zhejiang, 310012

    Jiangtao Zhang, Phd, 8618969125501, 18969125501@163.com

Other trials in China

About this study

Official title: A Prospective, Single-Arm Study Evaluating Silkworm Pupa Powder in Improving Alzheimer's Disease Among Patients

The goal of this clinical trial is to learn if silkworm pupa powder works to treat Alzheimer's disease in patients. It will also learn about the safety of silkworm pupa powder, and its effect on patients' nutritional and frailty status. The main questions it aims to answer are:

  • Does silkworm pupa powder improve cognitive function and daily living abilities?
  • Does silkworm pupa powder improve nutritional status and frailty?
  • What medical problems do participants have when taking silkworm pupa powder?
Read more

Researchers will evaluate the treatment by comparing the participants' conditions after taking the powder to their baseline conditions (a single-arm study without a placebo) to see if silkworm pupa powder works to treat Alzheimer's disease.

Participants will:

  • Take silkworm pupa powder every day for 12 weeks
  • Visit the clinic once every 4 weeks for checkups and tests
  • Use an electronic punch-card system daily and report any symptoms
Being tested
Silkworm pupa powder
Keywords
Silkworm Pupa Powder, Nutritional Status, Frailty State, Cognitive Function, Dietary Supplement
Medical subject headings
Alzheimer Disease, Sarcopenia, Asthenia, Frailty

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

Study groups in NCT07638449
Study groupRoleWhat they receive
GroupExperimentalSilkworm 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

  2. Bilateral Hippocampal Volume

    Bilateral hippocampal volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower hippocampal volume indicates greater AD-related brain atrophy.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  3. Entorhinal Cortex Volume

    Entorhinal cortex volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower volume indicates greater AD-related brain atrophy.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  4. Temporoparietal Regional Volume

    Temporoparietal regional volume will be measured using 3.0T structural MRI T1-weighted imaging. Lower volume indicates greater AD-related brain atrophy.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  5. Cortical Thickness of AD-Related Brain Regions

    Cortical thickness in AD-related brain regions, including the entorhinal cortex and temporoparietal cortex, will be measured using 3.0T structural MRI. Lower cortical thickness indicates greater cortical atrophy.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  6. Fractional Anisotropy

    Fractional anisotropy will be measured using diffusion tensor imaging to assess white matter microstructural integrity. Lower fractional anisotropy generally indicates reduced white matter integrity.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  7. Mean Diffusivity

    Mean diffusivity will be measured using diffusion tensor imaging to assess white matter microstructural changes. Higher mean diffusivity generally indicates greater microstructural disruption.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  8. Radial Diffusivity

    Radial diffusivity will be measured using diffusion tensor imaging to assess white matter microstructural changes. Higher radial diffusivity generally indicates greater white matter microstructural abnormality.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  9. Default Mode Network Functional Connectivity

    Functional connectivity of the default mode network will be assessed using resting-state functional MRI to evaluate AD-related brain network function.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  10. Salience Network Functional Connectivity

    Functional connectivity of the salience network will be assessed using resting-state functional MRI to evaluate AD-related brain network function.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  11. Amplitude of Low-Frequency Fluctuations

    Amplitude of low-frequency fluctuations will be measured using resting-state functional MRI to assess local spontaneous neuronal activity.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  12. Regional Homogeneity

    Regional homogeneity will be measured using resting-state functional MRI to assess local synchronization of neuronal activity.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  13. Blood Neurofilament Light Chain Concentration

    Neurofilament light chain concentration in blood will be measured as a biomarker of neuronal injury and neurodegeneration. Higher concentrations generally indicate greater neuronal injury.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  14. Aβ42 Concentration in Blood or Cerebrospinal Fluid

    Aβ42 concentration in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  15. Aβ40 Concentration in Blood or Cerebrospinal Fluid

    Aβ40 concentration in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  16. Aβ42/Aβ40 Ratio in Blood or Cerebrospinal Fluid

    The Aβ42/Aβ40 ratio in blood or cerebrospinal fluid will be measured as an Alzheimer's disease-related amyloid biomarker.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  17. Phosphorylated Tau 181 Concentration in Blood or Cerebrospinal Fluid

    Phosphorylated tau 181 concentration in blood or cerebrospinal fluid will be measured as a biomarker of tau pathology in Alzheimer's disease.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  18. Phosphorylated Tau 217 Concentration in Blood or Cerebrospinal Fluid

    Phosphorylated tau 217 concentration in blood or cerebrospinal fluid will be measured as a biomarker of tau pathology in Alzheimer's disease.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

Secondary outcomes (2)
  1. CIBIC-plus Score

    The Clinician's Interview-Based Impression of Change Plus Caregiver Input is a semi-structured interview tool used to assess global clinical change in patients with dementia after treatment. The score ranges from 1 to 7, with 1 indicating very much improved, 4 indicating no change, and 7 indicating very much worsened.

    Measured: The 0th、 4th 、8th and 12th week after taking Silkworm Silkworm pupa powder

  2. MMSE Total Score

    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.

    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.

  1. First posted10 Jun 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion31 Dec 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07638449
Sponsor's protocol ID
2026-063(L)-F1
Status last verified
Jun 2026
First submitted
29 May 2026
Last updated
10 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing Silkworm pupa powder in people with Alzheimer Disease 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 17 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 10 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. 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 18 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 10 Jun 2026.

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