Alzheimer's Disease Trial, Not Yet Recruiting NCT07638449 Sponsor: Zhejiang Provincial Tongde Hospital Condition: Alzheimer's Disease
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Alzheimer's Disease Trial, Not Yet Recruiting

NCT07638449
Not Yet Recruiting Not Applicable

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • People who have been diagnosed with probable Alzheimer's disease that is classified as mild to moderate, based on a standard memory and thinking test score between 0 and 24.
  • People whose Alzheimer's disease has been confirmed through blood or brain scan tests showing specific biological markers related to the disease (both amyloid and tau protein abnormalities must be present).
  • People aged 50 to 90 years (inclusive), of any gender, who have completed at least primary school education.
  • People whose Alzheimer's medications (if taking any) have been at the same dose for at least 12 weeks before the start of the study; people not currently on any Alzheimer's medication are also eligible, and other non-Alzheimer's medications must be stable for at least 4 weeks beforehand.
  • People whose score on a standard scale used to assess whether memory problems are related to blood vessel issues in the brain is 4 or below (confirm with trial site).
  • People whose score on a standard short depression screening test is 4 or below.
  • People whose brain scan (CT or MRI) shows age-related brain changes or brain shrinkage.
  • People who have a stable and reliable carer, as confirmed by the study doctor.
  • People who are able to give written consent themselves, or whose legally authorised representative can do so on their behalf, and who agree to provide blood, stool, and urine samples during the study.

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a type of dementia other than Alzheimer's disease, or another condition affecting the brain or nervous system.
  • People with unstable vital signs along with problems affecting the heart, lungs, liver, kidneys, or other major organs.
  • People with abnormally low folate or vitamin B12 levels, people whose dementia appears to be caused or worsened by an underactive thyroid, or people with an abnormal syphilis test result.
  • People who have been diagnosed with a psychiatric condition alongside their Alzheimer's disease.
  • People with long-term alcohol dependence or substance misuse that could affect how well the treatment can be assessed.
  • People who are intolerant or allergic to the study medication, which is silkworm pupa powder.
  • People whose brain MRI shows significant abnormalities such as stroke-related damage, fluid build-up in the brain, or brain tumours.
  • People who have been diagnosed with, or are currently being treated for, a significant heart or blood vessel condition within the past 12 months.
  • People whose depression screening test (GDS-15) score is above 4 at the screening stage.
  • People with any other poorly controlled health condition — such as heart, breathing, kidney, or digestive problems (including gastric cancer, gastric bypass surgery, or ongoing diarrhoea) — that could affect their safety or the study results, as judged by the study doctor.
  • People who have taken a new experimental drug as part of an Alzheimer's clinical study within the 6 months before screening.
  • People who have clinically significant abnormalities in physical examination, vital signs, blood tests, or heart tracing (ECG) that require further investigation, treatment, or that pose a safety risk.
  • People who have taken part in a clinical study involving therapeutic antibody-based treatments, immune protein therapies, or vaccines within the 6 months before screening.
  • People who have ever participated in a clinical study involving treatments designed to remove amyloid from the brain, including certain antibody therapies or BACE inhibitor therapies.
  • People with a poorly controlled immune disorder, or an immune condition that requires treatment with certain immune-modifying therapies during the study (confirm with trial site).
  • People with poorly controlled bleeding disorders, or whose blood clotting levels fall outside specified ranges; people on blood-thinning medication must have their dosing stabilised at least 4 weeks before screening, and must not take part in the spinal fluid (CSF) assessment part of the study.
  • People who are already taking part in another silkworm pupa powder study at the same study centre.

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 12 August 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Phone: +8618969125501

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Not Yet Recruiting
Phase
Not Applicable
Sponsor
Zhejiang Provincial Tongde Hospital
Registry
ClinicalTrials.gov
Start date
1 June 2026
Est. completion
31 December 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog); Bilateral Hippocampal Volume; Entorhinal Cortex Volume; Temporoparietal Regional Volume; Cortical Thickness of AD-Related Brain Regions; Fractional Anisotropy; Mean Diffusivity; Radial Diffusivity; Default Mode Network Functional Connectivity; Salience Network Functional Connectivity; Amplitude of Low-Frequency Fluctuations; Regional Homogeneity; Blood Neurofilament Light Chain Concentration; Aβ42 Concentration in Blood or Cerebrospinal Fluid; Aβ40 Concentration in Blood or Cerebrospinal Fluid; Aβ42/Aβ40 Ratio in Blood or Ce...

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 12 August 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov