Clinical Trial?

JJ401

Just received a phone call about two clinical trials that DH seems to be eligible for. Apparently (will call neurologist tomorrow- office closed now) his neurologist gave his name as a candidate for the trial. He had done a previous clinical trial that only involved him giving blood so I guess that indicated a willingness to be part of a trial.

First— a new phase four study of a drug from Biogen aimed at reducing amyloid plaque. Once a month infusion every four weeks for 2 1/2 years.

Second - phase four study of drug to reduce Tau plaque. Requires lumbar puncture. Infusions given through spine for two years.

Both studies require MRI and PET scans. 30% chance of placebo. 

I told them I’d talk to him, and his daughter, about it. They call back January 2 to see if we want to go forward.

Any thoughts?

M1

what stage is he? Will he easily cooperate? I think that's a key question. Personally i would be very loathe to receive intrathecal (spinal) injections, pretty invasive and risky. Not to mention potentially painful. I bet they'll have a very hard time recruiting for that study.

LaurCT

clinical trials are an important part of diseases that currently have no cure, & they are a very personal thing. Knowledge is empowering. Knowing exactly what the drug does where it is supposed to interact & how, are questions that should be asked. Especially for the lumbar puncture every 4 weeks for two years that’s pretty invasive. How long does the infusion take? 30 minutes, an hour? Is there also a flush time & how long. What’s the expected outcome, to slow the progression? A Cure? Is this the beginning of the trial or have there been other cohorts? If others in/were in an initial phase what were the results? How many participants & % of positive results. The first phase is a blind study (placebo), is it a double blind study where not even the center giving the drug knows if drug or placebo. What are side effects of drug? Phase two (lumbar phase) is that a guarantee of getting the drug during that phase? After the 4 yrs if good results will the person be able to continue on the drug as part of their incentive / compensation? Is there compensation for travel etc? Also remember the participant can drop out at any time. Most importantly as M1 said is the person able to go through it.

those are my thoughts before I’d decide.

Laura

housefinch

I would not personally consent someone with dementia for a clinical trial requiring periodic spinal taps (lumbar punctures) over 2 years. In the 2 years, the PWD could worsen to a point when they no longer understand why they are getting the procedure. It could be pretty challenging to endure, and I’m picturing how they would communicate about side effects (headache, evaluating the need for possible procedures to fix complications of a spinal tap, etc). My 2 cents only.

JeriLynn66

Agree with above... very invasive, painful and difficult to manage. I would not move forward with this ...

JJ401

Thank you for the comments. They called for a decision today as to if we would participate in one of the trials. I declined both.