Lilly clinical trial

Stuck in the middle

Saw an ad on TV soliciting participants for a trial of a new AD med.  DW said "I wonder if that might help me" so I went on line and signed her up.  We'll see how it goes.

Marta

What is the medication?

M1

If its Lilly, its probably domanemab(?), which is another one aimed at amyloid deposits I think. It'll be interesting to hear what you find out Stuck.

JJ401

We live near a hospital that has done and is doing clinical trials. They actually did trials for the drug that was just approved. I’ve often thought about trying to get DH involved in a trial. But, trials for drugs that attack plaque require MRIs and he is claustrophobic. He needed a prostrate MRI and let’s just say it was an ordeal that I don’t want to repeat.

Stuck in the middle if your husband wants to be in the trial, and he gets into one, congratulations. It’s only with trials that treatment advances. Thank you. 

Stuck in the middle

The medication is donanemab, a plaque-clearing drug.  The initial trial of 272 patients yielded a roughly 1/3 reduction in the rate of decline.  Not a cure, but better than nothing.

We are volunteering to participate in a second trial, involving more patients, to further test safety and efficacy.  The nearest test site is the clinic of a well-known local neurologist, about 15 miles from our home, so it won't require significant travel.  There will be MRI and PET scans, but DW isn't claustrophobic so no problem.

We are hopeful.  We hope she is chosen for the study.  If so, we hope she gets the drug and not the placebo.  If so, we hope it helps her.  Finally, we hope we will be able to buy the drug when and if it is brought to market.  The drug is injected, not taken orally, and is paused when plaques are reduced to certain levels.  A treatment requiring office visits and repeated imaging will not be inexpensive.

People in the early stages of AD who want to get in on this can check it out at www.trailblazer2study.com or call (844) 933-4084

Crushed

Stuck in the middle wrote:

The medication is donanemab, a plaque-clearing drug.  The initial trial of 272 patients yielded a roughly 1/3 reduction in the rate of decline.  Not a cure, but better than nothing.

I would find that a somewhat questionable way of describing the results

  The baseline iADRS score was 106 in both groups. The change from baseline in the iADRS score at 76 weeks was −6.86 with donanemab and −10.06 with placebo (difference, 3.20; 95% confidence interval, 0.12 to 6.27; P=0.04). The results for most secondary outcomes showed no substantial difference.

  iADRS is not a clinical tool and note the use of rate of change rather than absolute change

(sort of like "doubling" the  number of  sunny days in Seattle   by going from one to two

the absolute decline difference is abut 3 percentage points   3/106  That is very small

The rate of decline is 7/106   compared to 10/106

But assume for the moment the test score differences  

35/106  and 50/106   That is mathematically the same rate of change but would be a huge clinical difference in absolute terms.    

  

  

 

EVERYDAY

Stuck in the middle wrote:

The medication is donanemab, a plaque-clearing drug.  The initial trial of 272 patients yielded a roughly 1/3 reduction in the rate of decline.  Not a cure, but better than nothing.

We are volunteering to participate in a second trial, involving more patients, to further test safety and efficacy.  The nearest test site is the clinic of a well-known local neurologist, about 15 miles from our home, so it won't require significant travel.  There will be MRI and PET scans, but DW isn't claustrophobic so no problem.

We are hopeful.  We hope she is chosen for the study.  If so, we hope she gets the drug and not the placebo.  If so, we hope it helps her.  Finally, we hope we will be able to buy the drug when and if it is brought to market.  The drug is injected, not taken orally, and is paused when plaques are reduced to certain levels.  A treatment requiring office visits and repeated imaging will not be inexpensive.

People in the early stages of AD who want to get in on this can check it out at www.trailblazer2study.com or call (844) 933-4084

@Stuck in the middle, does your wife get in the Phase 3 testing, which started this month?

dayn2nite2

Please realize that every single drug that targeted amyloid has failed miserably in trial previously.

This one will also fail.

Calculate how much trouble it'll be to get your spouse to/from appointments, track results and get testing and decide whether you want to expend the energy.

EVERYDAY

"One who fears the future, who fears failure, limits his activities.  Failure is only the opportunity more intelligently to begin again"  HENRY FORD

Ed1937

Stuck, whatever happens, we're keeping our fingers crossed for you and DW.

Stuck in the middle

DW didn't qualify for the trial, due to some other medical conditions that are unrelated to AD but require medications that would adversely interact with the drug being tested.  

After a certain age, life turns into a game of whack-a-mole.  

Thank you for thinking of us.

EVERYDAY

DH got in and had his first infusion.  We'll see...

abc123

Stuck, I'm sorry it didn't work out.

Everyday, sending good wishes for a positive experience!

LadyTexan

@ midSTUCKdle

I am sorry that your DW did not get into the trial. I appreciate that you considered it and tried. Research and clinical trials will hopefully lead to future treatment and hopefully SOMEDAY a cure for this horrid disease. 

I know it is too late for my husband to benefit from any of the drugs and treatments currently being researched. However, I am comforted and encouraged if future generations may benefit.

God bless you.

EVERYDAY

One and a half years since DH has been on Lilly's Donanemab Placebo controlled trials.  He is still in the program and doing good.   It is going into an extension trial now that will last another 18 months.  I think that probably is the last trial for Lilly.

It is said that everyone were on the placebo will be getting the drug.  That's exactly what we wanted.  If DH has not been giving the drug, he will now.  I hope it will help him.

Ed1937

That's great! I hope everything works out well.