Silkworm Pupa Powder Improves Alzheimer's Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-90
SponsorZhejiang Provincial Tongde Hospital
About this trial
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?
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
Eligibility criteria
Qualifiers
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.
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Silkworm pupa powder
Treatment groups
100 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov