Re: Re: Fw: DS Clinical Trials- From Dr Craig Garner

July 5, 2008

Ann,

This is not Carol but no the DSRTF is run by Patti White O'Brien (a mom). Mobley and Garner are scientists who are a couple of the recipients of the fund raising. DSRTF has almost exclusively supported Stanford wth the one exception of Reeves at s Hopkins.

Garner would like to do a clinical trial w/ people to have a proof of concept. The concept to prove is that individuals w/ DS can have significant cognitive improvement through treatment with medicine.

DSRTF has not shown an interest in moving toward clinical trials, yet. I hope they will be interested in supporting this. It may be up to Changing Minds Foundation, the fundraising that Garner is doing on his own and Stanford's fundraising office.

It is very preliminary and probably should not have been brought up yet. But maybe it is better it has. In a few weeks, I should have an estimate of costs. How many participants and what they decide to use.

It is very, very, very exciting.Things are moving fairly quickly. I'll keep everyone posted as things develop,

Subject: [DownSyndromeInfoExchange] Re: Fw: DS Clinical Trials- From Dr Craig GarnerTo: DownSyndromeInfoExchange Date: Saturday, July 5, 2008, 1:17 PM

Carol,I saw in the other post that "Dr. Mobley has been put on the shelf" is this true? Is the foundation run by Garner now?We just met Mobley at a fundraiser and I was impressed. I wonder how we can raise money for this research, is it the same foundation DSRTF?Thanks,Ann>> I wrote to Dr. Garner and asked if he could please tell us about the clinical trials, research and prozac and he was kind enough to reply and allow us to post this to the list!!!> > I think it's fantastic that he took the time to keep us all informed!> > > > Carol in IL > > AIM doihavtasay1 GigaTribe doihavtasay> Mom to seven including , 7 with TOF, AVcanal, GERD, LS,

Asthma, subglottal stenosis, and DS.> > My problem is not how I look. It's how you see me.> > > Join our Down Syndrome information group - > http://health. groups.yahoo. com/group/ DownSyndromeInfo Exchange/> > Listen to oldest dd's music http://www.myspace. com/vennamusic> > > > ----- Forwarded Message ----> From: Craig C. Garner <cgarner@... >> To: Carol in IL <ps1272000@. ..>; and Tim Cashion > Cc: Kathy Ratkiewicz <Kathy_R@... >> Sent: Thursday, July 3, 2008 8:59:00 PM> Subject: DS Clinical Trials> > > Hi Carol and Kathy,> > Thank you for your email. I hope I can clarify

questions and concerns from your online community. > > First, I want to reiterate that I cannot advise any therapy for individuals with Down syndrome until they have been shown to be safe and effective in an approved study. Of course we are hopeful that therapies will be proven safe and effective as soon as possible, but for legal reasons we have to leave official advice to doctors and the FDA.> > Concerning a clinical trial we are most certainly not at a standstill. In fact, my efforts to start a trial require daily effort. We are aware of Cody's project, and we are inspired by the potential that our laboratory finding will transfer to the clinic. We are working to make a clinical trial a reality quickly -- a matter of months not years. Our team includes physicians, psychiatrists, neurologists, and scientists at Stanford and elsewhere who share my hope and are

working with us to find the best possible drug formulation that can be used safely and effectively in individuals with Down syndrome. > > As you can imagine, there are many administrative, organizational, and financial hurdles. Our biggest challenge is fundraising. Unfortunately, drug companies consider the risks too great and the potential payoff too small to fund a trial at this early stage, so we are working to raise funds through philanthropy. We have estimated the costs of a trial, and the required funds are manageable, but we will need help from your community -- and beyond -- to raise these funds.> > Many of the details of the trial are still being worked out at this time. We have many options for drug treatment strategies under consideration. With regard to Prozac, a decision has not been made whether it will be included in the first trial. When our plans and

protocol are finalized, we will certainly distribute those details to you and your community. Sadly, due to our many time commitments, we cannot update our websites as frequently as we would like. However, we are in the midst of a site redesign that we hope will greatly increase the rate of new content, including information on any trials. > > Best,> > Craig> > Craig C. Garner, Ph.D.> Professor of Psychiatry> & Behavioral Sciences > Pritzker Laboratory> 1201 Welch Road, Room P106> Stanford, CA 94305-5485> > cgarner@...> http://cgarnerlab. stanford. edu>

July 7, 2008

Hi Ann, Dr Mobley is far from being put on the shelf. :-) He is very actively researching! There is more than one issue to research and in the researcher's eyes, Prozac has not been proven to be *the* answer to growing new brain cells. Even Dr Garner is not sure that Prozac will be one of the drugs in the trial at this point. Terese is very passionate about Prozac, but it's not the only game in town. We would like to get more researchers or people in the know on this list to be able to give a broader view of the research going on- we are working on that. In the meantime, you are free to contact DSTRF and ask any question. I am assuming Dr Garner will apply to DSTRF for a grant. DSTRF has an advisory board that reviews all grants in an effort to

be responsible with the money and to choose those studies they feel will yield the biggest bang for our buck. Right now the clinical trials are in the very early stages!!! VERY EARLY.... as Dr Garner pointed out, not even sure prozac will be included. But before he can apply for a grant from DSTRF, the study has to be all written up and ready to go.... same is true I am sure for any other grant applications. )Bottom line though, as always, want DSTRF to be able to fund clinical trials? Send them money!! :-) It was their research funds that got this whole ball rolling in the first place!If we continue to concentrate our funds into one large group that will choose who to give grants to based on their extensive knowledge, we can do a lot more then just sending money off betting blind on who ever seems to look good to *us*, with very limited information as to the research going on.. So if Garner himself isn't totally sold on the idea of prozac

and it's not a slam dunk for the clinical, that alone should tell you something. Carol in IL AIM doihavtasay1 GigaTribe doihavtasayMom to seven including , 7 with TOF, AVcanal, GERD, LS, Asthma, subglottal stenosis, and DS.My problem is not how I look. It's how you see me. Join our Down Syndrome information group - http://health.groups.yahoo.com/group/DownSyndromeInfoExchange/ Listen to oldest dd's music http://www.myspace.com/vennamusic----- Original Message ----To: DownSyndromeInfoExchange Sent: Saturday, July 5, 2008 8:17:07 AMSubject: [DownSyndromeInfoExchange] Re: Fw: DS Clinical Trials- From Dr Craig GarnerCarol,

I saw in the other post that "Dr. Mobley has been put on the shelf"

is this true? Is the foundation run by Garner now?

We just met Mobley at a fundraiser and I was impressed. I wonder how

we can raise money for this research, is it the same foundation DSRTF?

Thanks,

Ann

>

> I wrote to Dr. Garner and asked if he could please tell us about

the clinical trials, research and prozac and he was kind enough to

reply and allow us to post this to the list!!!

>

> I think it's fantastic that he took the time to keep us all

informed!

>

> Carol in IL

>

> AIM doihavtasay1 GigaTribe doihavtasay

> Mom to seven including , 7 with TOF, AVcanal, GERD, LS,

Asthma, subglottal stenosis, and DS.

>

> My problem is not how I look. It's how you see me.

>

> Join our Down Syndrome information group -

> http://health. groups.yahoo. com/group/ DownSyndromeInfo Exchange/

>

> Listen to oldest dd's music http://www.myspace. com/vennamusic

>

> ----- Forwarded Message ----

> From: Craig C. Garner <cgarner@... >

> To: Carol in IL <ps1272000@. ..>; and Tim Cashion

> Cc: Kathy Ratkiewicz <Kathy_R@... >

> Sent: Thursday, July 3, 2008 8:59:00 PM

> Subject: DS Clinical Trials

>

> Hi Carol and Kathy,

>

> Thank you for your email. I hope I can clarify questions and

concerns from your online community.

>

> First, I want to reiterate that I cannot advise any therapy for

individuals with Down syndrome until they have been shown to be safe

and effective in an approved study. Of course we are hopeful that

therapies will be proven safe and effective as soon as possible, but

for legal reasons we have to leave official advice to doctors and the

FDA.

>

> Concerning a clinical trial we are most certainly not at a

standstill. In fact, my efforts to start a trial require daily

effort. We are aware of Cody's project, and we are inspired by

the potential that our laboratory finding will transfer to the

clinic. We are working to make a clinical trial a reality quickly --

a matter of months not years. Our team includes physicians,

psychiatrists, neurologists, and scientists at Stanford and elsewhere

who share my hope and are working with us to find the best possible

drug formulation that can be used safely and effectively in

individuals with Down syndrome.

>

> As you can imagine, there are many administrative, organizational,

and financial hurdles. Our biggest challenge is fundraising.

Unfortunately, drug companies consider the risks too great and the

potential payoff too small to fund a trial at this early stage, so we

are working to raise funds through philanthropy. We have estimated

the costs of a trial, and the required funds are manageable, but we

will need help from your community -- and beyond -- to raise these

funds.

>

> Many of the details of the trial are still being worked out at this

time. We have many options for drug treatment strategies under

consideration. With regard to Prozac, a decision has not been made

whether it will be included in the first trial. When our plans and

protocol are finalized, we will certainly distribute those details to

you and your community. Sadly, due to our many time commitments, we

cannot update our websites as frequently as we would like. However,

we are in the midst of a site redesign that we hope will greatly

increase the rate of new content, including information on any

trials.

>

> Best,

>

> Craig

>

> Craig C. Garner, Ph.D.

> Professor of Psychiatry

> & Behavioral Sciences

> Pritzker Laboratory

> 1201 Welch Road, Room P106

> Stanford, CA 94305-5485

>

> cgarner@...

> http://cgarnerlab. stanford. edu

>

July 7, 2008