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Doc328

08/04/24 1:50 PM

#466344 RE: Hosai #466342

Funny, I just asked chatgpt and got this:

Me: The FDA describes stages of dementia in this guidance https://www.fda.gov/media/110903/download. The CDR global is often used in clinical trials. Would CDR 0.5 correspond to Stage 2 or Stage 3
ChatGPT

Chat GPT: In the FDA guidance you referenced, the stages of dementia are described as follows:

Stage 1: Normal cognition
Stage 2: Subjective cognitive decline
Stage 3: Mild cognitive impairment
Stage 4: Mild dementia
Stage 5: Moderate dementia
Stage 6: Severe dementia

The Clinical Dementia Rating (CDR) scale includes:

CDR 0: No dementia
CDR 0.5: Very mild dementia (pre-dementia or mild cognitive impairment)
CDR 1: Mild dementia
CDR 2: Moderate dementia
CDR 3: Severe dementia

Given this, a CDR 0.5 is indicative of very mild dementia or mild cognitive impairment. Therefore, it corresponds more closely with Stage 3 in the FDA's guidance, which is mild cognitive impairment.

Stage 2 in the FDA's guidance refers to subjective cognitive decline, which is generally less severe than CDR 0.5 and more focused on self-reported cognitive issues without clear objective evidence of impairment.
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Doc328

08/04/24 2:04 PM

#466346 RE: Hosai #466342

I asked a different way and got the following answer.

Me: The FDA describes stages of dementia in this guidance https://www.fda.gov/media/110903/download. The CDR global is often used in clinical trials. Would CDR 0.5 correspond to Stage 2 or Stage 3

Gemini: Couldn't directly answer your question from the FDA document, but according to a web search the stages align with NIA-AA stages.

In the NIA-AA system, a CDR of 0.5 corresponds to stage 3: Mild Cognitive Impairment (MCI) due to Alzheimer's disease.

Let me know if you have other questions!