Silkworm Pupa Powder Improves Alzheimer's Disease

ConditionsAlzheimer Disease Sarcopenia Asthenia Frailty

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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

Silkworm pupa powder
Dietary supplement
Silkworm pupa powder, 2 times a day, two packets (12\*2 g) each time, take with warm water, before meals, for three months

Treatment groups

100 Participants

are divided into 1 treatment group

Group A: GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

The 0th、 4th 、8th and 12th week after taking Silkworm

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.

Time frame