Silkworm Pupa Powder Improves Dementia.

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.

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.

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

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,

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.