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Biogen Trial
luvliondogs
Posted: Friday, January 29, 2016 9:18 AM
Joined: 1/25/2016
Posts: 13


I'm new here so let me introduce myself to everyone.  

Here's my story…..my husband and I were told that he has MCI likely from ALZ about 7 weeks ago. Like probably everyone on this website, I knew something was wrong about 8 months ago - forgetting names became asking me more than once for information and word retrieval became evident in social situations. We landed at Mayo in Rochester….lots of neuropsych testing and MRI and FDG-Pet. 

They recommended the Biogen Trial. And if anyone wants info on that trial and getting into it, I'll happily share.  Of 21 people at this particular site, my husband will only be the 3rd person enrolled.  It's a slow and through process.  There's a a lot of money riding on this and they're taken a lot of care in designed the study.  

I've read all the criticisms, etc.  And the bottom line for us is this - why not? At Mayo they told us that on the MMSE the average decline is 3 points per year.  Forget the placebo group and how they calculated those numbers in the Phase 1b.  Let's look that the upside of the treatment group. If this drug can slow down the decline - possibly the 3 mg/kg arm can turn a 1 year 3 point decline into 4 years - then I'll take that and run with it!!!  My husband is 76 and between a 24 and 27 on the MMSE.  3 points over 4 years for us - that's HUGE.

Today is a sad morning, but maybe better described as bittersweet.  The results of the beta amyloid scan are positive.  Good news is that he's in the Trial - bad news is that the scan was positive - just makes all of this more real.

For any questions on this study, please ask.  It's very well designed in terms of minimizing the side effects. It's open label after 18 months.  And I am 90% sure that during the course of the study there is flexibility to add other ALZ meds.

In the meantime, I've been giving him great supplements for a 2 1/2 months…..Curcumin, resveratrol, ubiquinol, fish oil, probiotics, ala/alacar, vit D, sublingual methyl B12 and 5 - MTHF, sublingual glutathione and vitamin C. 

SUGGESTIONS WELCOME!!!

 


Lane Simonian
Posted: Friday, January 29, 2016 2:38 PM
Joined: 12/12/2011
Posts: 4833


I am sorry to hear about your husbands diagnosis.  A postive amyloid scan is not necessarily proof of Alzheimer's disease, but given the other information that you provided that is very likely the case.  

I am curious for the Biogen clinical trial did they ask what other medications or supplements that your husband is taking?

I think the supplements that your husband is taking are helpful.  A variety of essential oils via direct inhalation therapy may help as well including clove, bay laurel, lemon balm, and rosemary.  Korean red ginseng (panax ginseng) has worked well in a small-scale clinical trial.  Ginger and medicinal marijuana (depending on where you live) or synthetic THC (dronabinol) can help as well.


luvliondogs
Posted: Friday, January 29, 2016 5:10 PM
Joined: 1/25/2016
Posts: 13


Well, the medical marijuana could be fun - how does that help? 

How much panax gensing?  I could easily switch out Gingko/vinpocetine capsule for that.

As part of the paperwork and health history we provided the clinical site with the list of supplements.  They urged us to remain consistent throughout the trial.

What about adding essential oils to some olive oil for use in the shower as a moisturizer?



Lane Simonian
Posted: Friday, January 29, 2016 5:42 PM
Joined: 12/12/2011
Posts: 4833


I am glad that they keep track of the supplement information.  I thought that they would.

THC and cannabidiol in medicinal marijuana act as peroxynitrite scavengers.  This one is for glaucoma, but glaucoma is another disease in which peroxynitrites damage neurons.


In glaucoma, the increased release of glutamate is the major cause of retinal ganglion cell death. Cannabinoids have been demonstrated to protect neuron cultures from glutamate-induced death. In this study, we test the hypothesis that glutamate causes apoptosis of retinal neurons via the excessive formation of peroxynitrite, and that the neuroprotective effect of the psychotropic Delta9-tetrahydroxycannabinol (THC) or nonpsychotropic cannabidiol (CBD) is via the attenuation of this formation.

http://www.ncbi.nlm.nih.gov/pubmed/14578199

The essential oils can be added to olive oil (as a carrier oil) for a shower moisturizer.  You can look at some sites to see suggested ratios.

The study on panax ginseng for Alzheimer's disease used 9 grams a day and 4.5 grams a day. The lower dose produced almost the same results as the higher dose at one year (versus 24 weeks for the higher dose).


A 24-week randomized open-label study with Korean red ginseng (KRG) showed cognitive benefits in patients with Alzheimer’s disease. To further determine long-term effect of KRG, the subjects were recruited to be followed up to 2 yr. Cognitive function was evaluated every 12 wk using the Alzheimer’s Disease Assessment Scale (ADAS) and the Korean version of the Mini Mental Status Examination (K-MMSE) with the maintaining dose of 4.5 g or 9.0 g KRG per d. At 24 wk, there had been a significant improvement in KRG-treated groups. In the long-term evaluation of the efficacy of KRG after 24 wk, the improved MMSE score remained without significant decline at the 48th and 96th wk. ADAS-cog showed similar findings. Maximum improvement was found around week 24. In conclusion, the effect of KRG on cognitive functions was sustained for 2 yr follow-up, indicating feasible efficacies of long-term follow-up for Alzheimer’s disease.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659550/


Ginseng may be somewhat more effective than gingko in treating Alzheimer's disease.

 


luvliondogs
Posted: Friday, January 29, 2016 5:54 PM
Joined: 1/25/2016
Posts: 13


Take a look at the small study done by John Lewis at University of Miami using APMC.

Thoughts on that?

4.5 grams a day of red ginseng is a lot of ginseng capsules unfortunately!


Lane Simonian
Posted: Saturday, January 30, 2016 10:22 AM
Joined: 12/12/2011
Posts: 4833


Interesting regarding ginseng, it looks like the powder is more effective than the capsules. Unfortunately that means the cost of effectively treating Alzheimer's disease with Korean red ginseng just went up.

http://www.ebay.com/gds/How-To-Buy-Ginseng-/10000000001162600/g.html

Thanks for the reference to the study by John Lewis on aloe polymannose.  I will see what I can find about the mechanism now.

http://med.miami.edu/news/study-finds-dietary-supplement-improves-cognitive-functioning-in-alzheimers

http://www.ncbi.nlm.nih.gov/pubmed/22976077

This in a very general way is part of the explanation:

It has been observed in epidermiological studies that treatment with nonsteroidal anti-inflammatory drugs (NSAIDs) decreases the risk for developing AD. Unfortunately, clinical trials of NSAIDs in AD patients have not been very fruitful. Proinflammatory responses may be countered through polyphenols. Supplementation of these natural compounds may provide a new therapeutic line of approach to this brain disorder[54].


Some polysaccharides in A. vera have therapeutic properties such as immune-stimulation, anti-inflammatory, wound healing, promotion of radiation damage repair, antibacterial, anti-viral, anti-fungal and anti-oxidant.

I will try to watch for further studies.


luvliondogs
Posted: Saturday, February 6, 2016 10:03 AM
Joined: 1/25/2016
Posts: 13


And we're off and running! My husband got his first infusion on Thursday. He had a small weird headache after 30 minutes later and then said he felt a bit lightheaded or off yesterday.

I'm hoping that means he didn't get the placebo! Any ideas what the placebo is in thes cases? I just assumed it would be a saline solution?...


Lane Simonian
Posted: Saturday, February 6, 2016 10:28 AM
Joined: 12/12/2011
Posts: 4833


I hope that the results will be good. You usually don't see side effects with a placebo, so your husband is likely on the drug.  I don't think Biogen identifies what it is using as a placebo.
CaringM
Posted: Wednesday, March 2, 2016 11:18 AM
Joined: 3/2/2016
Posts: 1


The placebo in the Biogen study is just saline.
luvliondogs
Posted: Saturday, March 5, 2016 8:41 PM
Joined: 1/25/2016
Posts: 13


Infusion #2.....and a bit of a very slight odd headache. 

We are very hopeful....we were told that the Biogen trial is the best thing going at this time.

I watched something truly fabulous 2 nights ago. And it was inspirational.....it was the video of the 2015 meeting for the CureAlz foundation.

Dr Rudy Tanzi was amazing.......this is an organization that we all need to support. They are doing amazing work! I urge everyone to go to the website and watch this video! 


R.Shelp
Posted: Saturday, March 12, 2016 12:41 AM
Joined: 3/7/2016
Posts: 12


I am new but where are y'all getting the decline percentage or even the stages.
Lane Simonian
Posted: Sunday, March 13, 2016 10:44 PM
Joined: 12/12/2011
Posts: 4833


You are probably referring to the stages of Alzheimer's disease which are not set in stone. Here is one shortened description of those stages:


Global Deterioration Scale

Some health-care professionals use the Global Deterioration Scale, also called the Reisberg Scale, to measure the progression of Alzheimer's disease. This scale divides Alzheimer's disease into seven stages of ability.


Stage 1: No cognitive decline

  • Experiences no problems in daily living.

Stage 2: Very mild cognitive decline

  • Forgets names and locations of objects.
  • May have trouble finding words.

Stage 3: Mild cognitive decline

  • Has difficulty travelling to new locations.
  • Has difficulty handling problems at work.

Stage 4: Moderate cognitive decline

  • Has difficulty with complex tasks (finances, shopping, planning dinner for guests).

Stage 5: Moderately severe cognitive decline

  • Needs help to choose clothing.
  • Needs prompting to bathe.

Stage 6: Severe cognitive decline

  • Loss of awareness of recent events and experiences.
  • Requires assistance bathing; may have a fear of bathing.
  • Has decreased ability to use the toilet or is incontinent.

Stage 7: Very severe cognitive decline

  • Vocabulary becomes limited, eventually declining to single words.
  • Loses ability to walk and sit.
  • Requires help with eating.

Irish Bea
Posted: Tuesday, May 10, 2016 2:04 AM
Joined: 6/23/2015
Posts: 2


I'm wondering the same thing!