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Antidepressants and Clinical Trials
GenaB
Posted: Monday, February 20, 2017 10:56 PM
Joined: 5/12/2016
Posts: 2


My mom has ALZ and her husband isn't really giving me information on her doctor visits or the trials he is trying to get her in. She is depressed and crying a lot but her husband says she can't be on antidepressants when entering the trial. But she also can't be depressed. If you can't be on mood meds then I'm wondering if the focus should be on her well being rather than trying to get her into a trial (she has already been released from one and has failed the initial screenings of several others; supposedly). She supposedly has mild ALZ, according to her husband, but she seems to exhibit several signs of moderate. Does anyone have any info on the Aducanumab clinical trial? Is he being honest about not being allowed to take antidepressants?
Lane Simonian
Posted: Monday, February 20, 2017 11:46 PM
Joined: 12/12/2011
Posts: 5002


Welcome, GeneB.  I hope that the information that you are given on this site will be helpful to you.

Here is a partial list of the aducanumab trial criteria and exclusions.  It does not mention the use of antidepressants but then again it is not a complete list of exclusions.

https://clinicaltrials.gov/ct2/show/NCT02484547

There are a number of things that make me suspicious about the touted trial results.  One is at 26 weeks there was very little difference in cognition changes between various doses of the drug group and the placebo group.

https://www.thestreet.com/story/13212080/1/previewing-the-next-look-at-biogens-alzheimers-drug.html

Some but not all of the apparent slowing down of the progression in the drug group versus the placebo group after that is due to the fact that about 40% of the people in the drug group (particularly at the higher doses) with the ApoE4 gene dropped out of the trial due to severe adverse effects while very few people with the ApoE4 gene in the placebo group did.  This is important because people with the ApoE4 gene usually progress faster during the early stages of Alzheimer's disease.






GenaB
Posted: Tuesday, February 21, 2017 10:16 AM
Joined: 5/12/2016
Posts: 2


Thank you for this info, Lane. She was enrolled in an Azeliragon study but he chose to take her out of it to pursue this one. I know clinical studies are important but I'm wondering if we should try and suggest that he just take care of her and keep her as happy and healthy as possible. She has been off of serotonin reuptake for almost two months and the rest of the family can really see a decline in her overall well being. Plus it can take ~6 weeks to complete the initial screening for the new study, according to her husband, which means she'll be off of the mood meds for at least 2 more months. Her immediate well being is my first concern and it's incredibly frustrating that it appears it's not the first priority for him. I'm sure he probably believes he's doing the right thing but she was diagnosed a year ago and there has been no consistency with medical care or day to day care, to include ensuring she takes her other medications daily, exercising and eating right. And the fact that we have no legal rights to ensure she has the best care, or even good care, is infuriating because he won't listen. Sorry, now I'm just venting. Thank you again for your response. 
Lane Simonian
Posted: Tuesday, February 21, 2017 12:38 PM
Joined: 12/12/2011
Posts: 5002


You are welcome for the information, GenaB.  I always think, too, do what is best for the person with dementia.  The problem is when different family members have different ideas about what is best for their loved one.

While I recognize the importance of clinical trials, most of the drugs currently in clinical trials are just nibbling around the edges of Alzheimer's disease.  If (and I am not sure how many drug protocols do this) a person is required to be taken off beneficial medications to be in the trial then the impetus for participating in the trial drops even further.


The_Sun_Still_Rises
Posted: Thursday, February 23, 2017 8:59 AM
Joined: 7/24/2015
Posts: 3020


In general...clinical trials have be strict in that NO thing else is interfering with the results.   Antidepressants (although some have true pre-existing chemical imbalances and need and benefit from) in general tend hasten dementia....and as such, would tend show that a drug not working, when in fact, it may be working.  That may be the reason they say this as one their requirements?  Just a thought. 

<3


BlueSkies
Posted: Thursday, February 23, 2017 10:05 AM
Joined: 2/24/2016
Posts: 1096


GenaB, 
I would like to come at this with a little different perspective.  It is unlikely that you can make your FIL do what you think is best for your mom so I think your best bet at helping your mom is helping educate FIL on how to best help your mom.  Help him learn what is best and works for your mom.  Help him to feel good about making your mom comfortable her last years.   Knowledge and gentle persuasion can go a long way and is much better than telling someone they aren't doing something right.  
Good luck to you, your mom and FIL on this very difficult journey.  Keep us posted on how you are doing.