I will have to read your post a few times to see if it all works for me but my reaction is...YOU GOT IT. I would emphasize that this is an evolving process for data gathering. The greatest advantage to the use of the monitoring devices is the real time learning opportunity it provides the medical/science people. Not only can the total elapsed time of the trial be reduced by concurrent processing but the learning process is greatly enriched by the interactive nature of the H/W-S/W systems dynamics possibilities. So, we end up with richer, more representative treatment data in a shorter amount of time. Very exciting stuff for a lab rat.
Trials should be about learning from the patients and the variables of real time science at work within the systems dynamics provided. This, compared to putting a note in a bottle and waiting for it to come back.
Brilliant work Bios. BTW, you have outlined what I believe Dr. M. and the trials team are either doing now in stealth or what they will be doing. I also think the ultimate HH AD paper will refer to this method. We'll see.
Primary Outcome Measures : ADAS-Cog (Alzheimer Disease Assessment Scale-Cognition) [ Time Frame: 48 weeks ] Change from baseline to week 48 in cognition according to the Alzheimer Disease Assessment Scale-Cognition (ADAS-Cog) compared to placebo
ADCS-ADL (Activities of Daily Living) [ Time Frame: 48 weeks ] Changes from baseline to week 48 in ability to perform daily activities according to the Activities of Daily Living Scale (ADCS-ADL) compared to placebo
Secondary Outcome Measures : Number of participants with treatment-related adverse events as assessed by CTCAE v4.03 [ Time Frame: 48 weeks ] Assess the safety and tolerability of ANAVEX2-73 compared to placebo
CDR-SB (Clinical Dementia Rating Scale Sum of Boxes) [ Time Frame: 48 weeks ] Change from baseline to week 48 on Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) compared to placebo
RSCAQ sleep score [ Time Frame: Weeks 0, 4, 12, 24, 36, and 48 ] To evaluate whether ANAVEX2-73 improves sleep continuity as assessed on a serial basis (weeks 0, 4, 12, 24, 36, and 48) with a questionnaire that assess reported sleep continuity (RSCAQ)
Other Outcome Measures: Number of participants with change of brain volume assessed by MRI [ Time Frame: 48 weeks ] Structural (and optional ASL) MRI scan assessments characteristic for AD pathophysiology from baseline and compared to placebo at +48 weeks
Blood assessment [ Time Frame: 48 weeks ] Blood assessment from baseline and compared to placebo at +48 weeks: Abeta40, Abeta42, T-tau, NFL, YKL-40, BACE1 concentration
CSF assessment [ Time Frame: 48 weeks ] Changes in CSF parameters (Abeta40, Abeta42, T-tau, P-tau, NFL, YKL-40, neurogranin, BACE1 concentration) characteristic for AD pathophysiology from baseline and compared to placebo at
+48 weekstreatment differences within subgroups will be performed
Number of participants with pre-specified genetic variants [ Time Frame: 48 weeks ] AD relevant pre-specified genetic variants will be assessed. Statistical testing of treatment differences within subgroups will be performed
I made an extra effort to dig into the Cognision site, approval trials, design and function. I studied why my machine learning investment program likes the “slow, steady” enrollment of our AD trial and assigned it a higher probability of success.
I know CMU is perhaps the top center in the USA for AI, machine learning,etc.
My questions:
1. What is the investment track record (ROI) of this program?