[Fwd: [DSTNI] Update on clinical DS trial]

[Guest guest]

Hello

one of the list members made me aware of a mistake when I stated that

" the short term memory of DS mice was amazingly restored to normal by

feeding them a mix of milk and Prozac, a drug usually used as

antidepressant which promotes neurogenesis. " It should read: " the number

of neurons in the hippocampus was amazingly doubled by feeding them... "

The part about short term memory being restored was conjecture, based on

the fact that Prozac restores memory function in people whose

hippocampal neurogenesis is compromised, which is usually termed

depression, one consistent symptom of which is impaired memory function.

(Interestingly this is why it takes antidepressants so long to work,

i.e. until new neurons have grown)

-------- Original-Nachricht --------

Betreff: [DSTNI] Update on clinical DS trial

Datum: Sun, 06 Sep 2009 15:52:47 +0200

Von: Müller

Antwort an: DSTNI

An: DSTNI , DSRF , DSInfoEx

<DownSyndromeInfoExchange >

Hello all

I've been emailing with Alberto Costa during the last few days and I'd

like to share with you what I have learned from him an the clinical

trial he is currently conducting, as he is clearly very much expecting a

positive outcome.

Many of you may remember that Alberto Costa is a research scientist with

a 13 year old daughter with Down Syndrome. Ever since she was born he

has been on the lookout for the possibility of a cognitive therapy, and

actually he has just recently received the " phine Mills Award " for

his tireless research efforts in behalf of people with DS. Due to the

" invention " of the DS-mouse and the Human Genome Project there have been

great advances in Down Syndrome research during the last few years. We

were all thrilled with the news coming from the Stanford Down Syndrome

research centre, where Doctors Mobley and Garner are at the forefront of

developing therapies for people with Down Syndrome, aiming at improving

their cognitive abilities. They have both not yet reached the stage of

translating their research from the lab to the clinic, though.

A few years ago we read about the study in which the short term memory

of DS mice was amazingly restored to normal by feeding them a mix of

milk and Prozac, a drug usually used as antidepressant which promotes

neurogenesis. This was Alberto Costa from the Eleanor Roosevelt

Institute at the University of Denver, whose laboratory has, by the way,

recently moved to the Colorado Health Science Center. About a year ago

he told me that he was on to something much more promising than Prozac.

At that time he wasn't in a position to divulge any more information,

but this has now changed. Here's what he told me about the clinical

trial now underway:

It is titled: " A Sixteen-Week, Randomized, Double Blind,

Placebo-Controlled Evaluation of the Efficacy, Tolerability and Safety

of Memantine Hydrochloride on Enhancing the Cognitive Abilities of Young

Adults with Down Syndrome. " Memantine is a drug currently approved for

the treatment of patients with Alzheimer's disease in the US and EU. The

study has been funded as an Investigator Initiated Trial by the Forest

Research Institute, has received the OK from the FDA and institutional

review board approval. A total of 40 persons with DS of both genders and

between the ages of 18 and 32 are being recruited in conjunction with

the Mile High Down Syndrome Association, the Denver Adult Down Syndrome

Clinic, and the Colorado Springs Down Syndrome Association. At the time

of writing, Alberto Costa has recruited 40% of the target number of

participants for this trial, eight individuals (20%) have already

completed the entire protocol, and five more persons are currently

taking the study medication. Because of the double-blind nature of the

study, he will not be able to analyze efficacy outcomes until all

participants complete the entire protocol and the randomization codes

are unsealed. So far, he goes on, compliance has been outstanding (over

95% for all participants), and the study medication has been well

tolerated. He is planning to upload more information on the trial at

clinicaltrials.gov in one or two months from now, and he is currently

expecting the results to be ready for publication in 12-18 months from now.

In case you would like to learn more, you can contact him through the

Univ. of Denver website at

http://www.ucdenver.edu/about/newsroom/newsreleases/Pages/SchoolofMedicineResear\

chAwardDownSyndrome.aspx

or

http://www.metrodenver.org/news-center/metro-denver-news/UC-Denver-research-Down\

-syndrome-award.html

(scroll down to the bottom for e-mail address)

Switzerland

--

with Saskia, Nora-Jane*2001, *2004/DS

(Algal DHA, highly dosed CoenzymeQ10, Vit. A, buffered Vit. C + natural

Vit. E, highly dosed Vit. D, Folic + Folinic Acid, B6 + Methyl-B12,

Trimethylglycine, Selenium, Zinc, Probiotic, Ginkgo Biloba + St. s

Wort, Iron, Prilosec, Thyroxine)