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Monday, October 05, 2015 12:11:53 AM
PK sampling- blood test results [ Time Frame: First part (PART A), first period (hours): 1, 48, 264; second period (hours): 1, 72, 264; extension period (PART B): Week 1, 12 and 26. ] [ Designated as safety issue: No ]
Mini-mental state examination score (MMSE) [ Time Frame: Baseline, and during the extension period at Week 1, 12, 26, 38 and 52 ] [ Designated as safety issue: No ]
Score from ADCS-ADL (Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory) [ Time Frame: Baseline, and during the extension period at Week 1, 12, 26, 38 and 52 ] [ Designated as safety issue: No ]
Cogstate Brief Battery (CBB) Score and International Shopping List Task (ISLT) Score [ Time Frame: At baseline, Day 1, 2, 6, 9, 12 of Period 1 and Day 1, 2, 6, 9, 12 of Period 2 and during the extension period at Week 12, 38 and 52. ] [ Designated as safety issue: No ]
Electroencephalographic activity, including event-related potentials (EEG/ERP) [ Time Frame: baseline, Day 1, 5, 11 of Period 1 and Day 1, 5, 11 of Period 2 and, Week 12, 38 and 52 of the extension period ] [ Designated as safety issue: No ]
Hamilton Psychiatric Rating Scale for Depression (HAM-D) Score [ Time Frame: Baseline at Period 1 ] [ Designated as safety issue: No ]
Rosen Modified Hachinski Ischemic Score (RM/HIS10) [ Time Frame: Baseline at period 1 ] [ Designated as safety issue: No
The PR states:
"Preliminary measured Mini Mental State Examination (MMSE) and Cogstate scale changes are consistent with the observed trend of the cognitive EEG/ERP effect".
I think by "Cogstate" they are referring to the ERP cognition wave. The only reference to ADAS-cog made in the poster pertains to the Donepezil reference study. They compare the change at 36 days to the Donepezil study's P300, but not it's ADAS-cog and MMSE. Check the poster:
http://www.anavex.com/wp-content/uploads/2015-07-22_Poster_AVXL_Phase_2a_AAIC_July_2015.pdf
I used the same assumption concerning test periods when reading the conference title in concluding that this next data release would be Primary Outcome results for PART A and interim data for PART B partial patient set at 12 weeks. I think you are back-stretching that. They have released no data on ADAS-cog and MMSE changes as I read it. Is the ADAS-cog a combining of ADCS-ADL and CBB? I'm an amateur, so continue to correct me if I'm wrong, please.
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§AVXL
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