That's an incomplete explanation, or inaccurate understanding, of the placebo effect in clinical trials, including Alzheimer's. Include the concept of time and you'll improve it.
“We’ve certainly seen individual patients, who both seem to be getting side effects from the drugs and who have shown significant improvements,” Professor Macfarlane told AAA.
“The findings we’ve got can only be anecdotal because it’s a double-blind trial, which means at the moment, we don’t know who’s taking the actual drug and who’s taking the placebo,” said Professor Macfarlane, head of clinical services at HammondCare.
Stephen Macfarlane Participants getting side effects, such as dizziness, suggest improvements from the drug, he said.
“The fact that they’re getting side effects and they were expected side effects based on what we know about the drug, does suggest that the people who are showing the improvements are on the active drug,” Professor Macfarlane said.
“For individual patients who have received benefits, the impact for them has been potentially life changing, such as resuming activities they previously had given away, more interest in life, more engagement and better able to converse,” he said.
There are currently over 500 participants in OLE (Open Label Extension) studies taking Blarcamesine each and every day.
NOW when Anavex, the investigators at each trial site, each family are siing significant improvement in patients in the OLE (Open Label Extension) Blarcamesind trials that were not improving in the placebo controlled trials, then that give Dr. Missling and Anavex 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