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Biotech / Medical : Neurobiological Tech (NTII)
NTII 0.00010000.0%Mar 7 3:00 PM EST
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To: Mike McFarland who wrote (628)7/29/1999 5:32:00 PM
From: Dr. John M. de Castro  Read Replies (3) of 1494
 
News from the AIDS Dementia Trial
I just perused the website for the AIDS TRAILS and lo and behold what should I find about the memantine trial for dementia:

130.14.32.45

"[AS PER AMENDMENT 4/6/99: The open-label phase has been extended by 48 weeks to a total of 60 weeks of therapy. Patients who did not receive the initial 12 weeks of open-label treatment are still eligible for the 48-week open-label treatment phase.]."

Now why do you think that an open label phase would be extended? If memantine was not helping do you think that the patients would want to continue? Do you think that the agency would extend the open label phase? Look at how much it's being extended. IMHO this is great news and suggests that we are going to see some dynamite results when the double blind treatment phase results are released. If that isn't enough good news, I also discovered that as of July 14, patient accrual is past the required number. This means that the full complement of patients should have completed the non-open label portion of the trial in December.

" PROJECTED ACCRUAL: 120 patients.
ACTUAL ACCRUAL: 122/120 990714. "

This is excellent progress. I am particularly excited by the open label extension. Remember that if the results are clear, this trial will be considered pivotal and NTII will submit an NDA based on them. We could see and NDA filing in the middle of 2000.

Best regards
John de C
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