News Focus
News Focus
icon url

Hosai

08/04/24 2:09 PM

#466348 RE: Doc328 #466346

Well I just put your answer into gemini and said "is this true" and it said this -

"The information you shared about the post and your response is partially correct, but there's a key point to clarify regarding the FDA guidance and AD stages.

Here's a breakdown:

The post is correct: The FDA guidance (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/early-alzheimers-disease-developing-drugs-treatment) does describe stages of Alzheimer's disease (AD) relevant to clinical trials.
Your response is partially correct: You mentioned the stages align with NIA-AA stages, which is generally true. However, there's a discrepancy between the FDA guidance and the typical clinical understanding of CDR scores in relation to AD stages.

Here's the key point:

The FDA guidance seems to categorize Mild Cognitive Impairment (MCI), which often corresponds to a CDR of 0.5, as Stage 3. This stage is characterized by mild but detectable functional impairment.

However, in clinical practice:

A CDR of 0.5 typically signifies Stage 2 of early AD, marked by subtle cognitive decline without significant functional impairment.
Stage 3 in the clinical context usually refers to MCI with more noticeable functional difficulties."
icon url

kevindenver

08/05/24 1:12 PM

#466439 RE: Doc328 #466346

As you all discuss the clinical side if dementia, I'm curious on your take on a biological factors as being a diagnostic indicator before any clinical stage is recognized?

I'm mixed on the issue, but for all drugs, it seems we need to intervene as early as possible for efficacy.

I'm curious on people thoughts on the issue.