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Re: Doc328 post# 466346

Sunday, 08/04/2024 2:09:13 PM

Sunday, August 04, 2024 2:09:13 PM

Post# of 517499
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."
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