Friday, August 04, 2017 1:22:09 PM
Remember, just because there is enrollment does not mean it happens right away. There is a workup that needs to be done and for sure new inclusion and exclusion criteria that will be used for this upcoming study when all the pk/pd, ariana dna/rna data mining is all said and done.
From the p2a study:
Main Inclusion Criteria:
1)Diagnosis of Probable AD in accordance with NINCDS-ADRDA criteria.
2)A brain CT or MRI scan performed within last 12 months from day of screening consistent with the clinical diagnosis of probable AD.
3)Age from 55 to 85 years inclusive.
4)MMSE score of 16-28 inclusive.
5)Rosen Modified Hachinski Ischemic score <=4.
6)Community dwelling with caregiver who has regular contact with the subject for at least 10 hours per week and is able to oversee the patient's compliance with study medication and participate in the patient's clinical assessment and is capable of accompanying the participant on all clinic visits.
7)Fluency in English.
8)Be able to read, write, speak clearly for the cognitive tests, with eyesight and hearing sufficient to enable completion of the cognitive tests.
9)Receiving stable doses of medications for the treatment of non-excluded medical conditions for at least 30 days prior to screening.
Main Exclusion Criteria:
1)Dementia other than AD such as AIDS, CJD, LBD, CVD, Progressive Supranuclear Palsy, Multiple cerebral infarcts, or normal pressure hydrocephalus.
2)Other neurodegenerative diseases, including Parkinson's disease and Huntington's disease, or cerebral tumour.
3)Current presence of a clinically significant major psychiatric disorder according to the criteria of the DSM-IV, or symptom that could affect the participant's ability to complete the study). HAM-D score >12.
4)Current clinically significant systemic illness that is likely to result in deterioration of the patient's condition or affect the patient's safety during the study.
5)Any other criteria which in the opinion of the Investigator causes the participant not to qualify for the study.
Screening process will take time and depending on the parameters of the next study, it could take longer than the last study.
Anyway, enough ranting. Back to the original conversation, Macfarlane would have had to sign an NDA so he would be in a lot of trouble if he says anything material without it being PR'd. Honestly though, you really think that if something material was going to be said at this event Missling would not be in attendance?
Then again if Ivanka can represent the American people at the G20 summit then I suppose anything goes.
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