I've been in several of these meetings at the Alzheimers' research roundtable discussing this project. I know for a fact that Bapineuzumab was the drug of choice 3 months ago and ADCS was having a hard time getting JNJ/PFE to committ to it. I think now it will be crenezumab, soanezumab or gantenerumab. For this project, the safety of the drug is quite important. Solanezumab safety profile looks great. crenezumabs theoretically should look good, I don't have any info on gantenerumab safety profile
1) it is only using 1 molecule, and the company and ADCS will jointly discuss with regulators prior to initiating
2) It is pivotal. They are going for a registration trial.
3) Initial sample size estimates are between 800-1200 patients and 3 yrs of tx duration
4) ADCS/NIH paying for half
5) All ADCS investigators will be used including partnerships in EU and Can. The goal is to make it the priority trial for all of them.
6) INclusion. Subjects 70-85 yo, with zero symptoms but positive amyloid. They expect to screen 8000 patients to get the 1000 for the trial.
7) The company chosen to provide radioligand (lilly's amyvid or GE's flutemetamol) will provide the ligand for free
IF positive, this could lead to rapid PET screening and open up a very large market.
the other 2 trials are familial AD. The columbian trial is probably the most homogenous, as it is a single mutation that results in dementia.
The DIAN study is using pts with multiple mutations,
ApoE+ is not a factor in these trials. Apoe+ is important but not a predictor of AD
