Replies to post #329826 on Anavex Life Sciences Corp (AVXL)

[georgejjl]

Dr. Missling and Anavex have confidence in the success of the Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled 48-week Safety and Efficacy Trial of ANAVEX2-73 for the Treatment of Early Alzheimer's Disease (AD) and the follow on Open Label Extension Study for Patients With Early Alzheimer's Disease (AD) Enrolled in Study ANAVEX2-73-AD-004.

What is next???

Anavex planning a Phase 3 prevention trial of ANAVEX®2-73 including participants at risk for cognitive and functional decline related to Alzheimer’s disease

https://www.anavex.com/anavex-life-sciences-announces-anavex2-73-blarcamesine-significantly-prevented-a%ce%b2-abeta-induced-cognitive-deficits-with-confirmed-significant-biomarker-response-in-animal-model-of-alzhe/


Good luck and GOD bless,

[falconer66a]

Placebo stuff again?

NO BLINDING OF THE Open Label Extension Study

Aw, that's just awful news.

Everyone knows that if patients in a clinical trial of a drug actually don't know if the pill they are taking is real, by the placebo effect they will mentally work up and produce otherwise invalid clinical results.

So, in the Open Label Extension (OLE) study, any good results will just have to be attributed to the placebo effect, not blarcamesine itself.

I know of the placebo effect, in Alzheimer's myself. My father, an accomplished public accountant, began to have trouble remembering things. My mother, an experienced geriatric nurse, saw things exactly. Dad had Alzheimer's setting in.

Because of her medical contacts, mother enrolled dad in one of the FDA-approved clinical studies of Aricept (donepezil) at a nearby medical school. Not long into the study, mother said that whatever this new drug was, if dad was in the experimental (drug-taking) arm of the study, it was producing no therapeutic results. Dad's cognition continued to decline unabated through the entire long trial period.

For me, in this particular incident, it proved one of two things: a) if my dad was taking donepezil, it failed; or b) if he wasn't, was in the control arm of the study, taking a disguised starch pill, he was unable to generate any sort of placebo effect. By the force of mental willpower ("I'm taking a powerful new drug that will help!"), he was unable to reverse any Alzheimer's symptom. There can be no placebo effect in Alzheimer's. Determined or hoped-for willpower can't fix the biochemical anomalies of the neurons in Alzheimer's.

So, let's watch; to see how the OLE results are interpreted by the news media. Will they be attributed to blarcamesine itself, or to the placebo effect?