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burtzev OP t1_j7h7d8w wrote

Sadly, despite earlier reports of (slight) efficacy this study found that treatment with Tilavonemab wasn't significantly better than placebo.

>A total of 453 patients were randomized, of whom 337 were treated with tilavonemab (300 mg, n = 108; 1000 mg, n = 116; 2000 mg, n = 113) and 116 received placebo. Baseline demographics and disease characteristics were comparable across groups. The mean age was 71.3 (standard deviation [SD] 7.0) years, 51.7% were female, and 96.5% were White. At baseline, the mean CDR-SB score was 3.0 (1.2), which worsened through Week 96 for all treatment groups. The least squares mean change from baseline at Week 96 in the CDR-SB score with tilavonemab was not significantly different compared with placebo (300 mg [n = 85]: −0.07 [95% confidence interval (CI): –0.83 to 0.69]; 1000 mg [n = 91]: −0.06 [95% CI: –0.81 to 0.68]; 2000 mg [n = 81]: 0.16 [95% CI: –0.60 to 0.93]; all P ≥ 0.05). The incidence of any adverse event and MRI findings were generally comparable across groups.Tilavonemab was generally well tolerated but did not demonstrate efficacy in treating patients with early Alzheimer’s disease. Further investigations of tilavonemab in early Alzheimer’s disease are not warranted.

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AllanfromWales1 t1_j7hb6m4 wrote

Why does this include the results for the three doses of tilavonemab, but not for the placebo group?

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burtzev OP t1_j7hc4hw wrote

Three different amounts of the drug. As for placebo it would be 'hard' to devise 3 different amounts of nothing in solution. Maybe one could lie to the control group and tell them that they are getting different doses of the nothing solution. The article compares the effects to the placebo, hence the results are implicit in the design.

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Brain_Hawk t1_j7hw0ee wrote

You don't have to dose placebo. You tell the participants there are either two or four conditions in a case like this. Most likely you've reveal the full design, that they will either receive a placebo or one of three doses of the drug. After that the participant and the researchers are blind as to what condition each participant is in. Until after the analysis is done.

You are not ethically allowed to lie to people and tell them they will receive medication when they might receive a placebo. They have to be aware that the possibility of placebo is there.

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burtzev OP t1_j7hxed2 wrote

I know. The part about lying was deliberately facetious. Unless you get the ethics committee really drunk before the meeting of course. The question in the comment was phrased such that I couldn't say if the author meant 3 different doses of placebo or if they had missed the part where all the doses were compared to placebo. So I covered both bases with a little sugar pill of humour.

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KetosisMD t1_j7i14jt wrote

That’s nuts.

I can’t believe anyone prescribed dangerous placebos.

It’s hard to know what is more broken the FDA or Healthcare

Edit

> 1.5 million treated

No, 1.5 million would be eligible. CMS denied coverage to anyone who isn’t in a trial.

This is good news. I was hoping CMS would pass on this drug and they did.

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Call_In_The_Bin t1_j7j3e1v wrote

By the time they figure out Alzheimer's I'll be an incontinent drooling vegetable. They've been spinning their wheels for 20 years, I swear.

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