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NAVB Oldtimers Lounge
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Re: alz info questionYou're welcome, I appreciated the link - made me relook at the monoclonal antibody therapy candidates. If anyone is interested , here's how to tell that the study is Phase I (safety study) from the link deut provided. Study Design:
Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment Official Title:
A
Multi-center, Multiple-ascending Dose, Randomized, Double-blind,
Placebo-controlled, Parallel-group Study to Investigate the Safety,
Tolerability and Pharmacokinetics of Gantenerumab Following Subcutaneous Injection in Japanese AD Patients You can also check by the Top Line Measures (note that there are no measures of efficacy) Primary Outcome Measures:
They are collecting some data related to efficacy, but only as secondary (read as: "We might as well, something interesting might turn up.") Secondary Outcome Measures:
But it's not likely, given a sample size of 28 divided into 4 groups (7 subjects per) and a pretty broad inclusion range (MMSE 16 to 26), that the cognitive and behavioral measures would reach statistical significance, and if they don't, then the Abeta and tau measures won't have any clinical meaning, even if those measures do reach significance. |
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