I'm new to this message board, so hopefully this topic is appropriate here and hasn't been addressed extensively elsewhere. My dad has been in the Phase III Myriad Genetics flurizan study for about 10 months. It is a double blind study, so we don't really know if he is on the drug or just a placebo.

I do think that dad is on the trial drug and would be interested to know if others involved in the study were experiencing similar changes in their loved one's functioning. They aren't big changes, but significant from my perspective. For example, today he remembered he was working on a puzzle yesterday, and said he wanted to work on it again today. He fell a few days ago, and rather than wondering why he is sore, he brought up that he fell a couple days ago. He will occasionally remember where he ate when asked a few hours later - before he would always forget. In general I've noticed an increase in his ability to recall recent events more frequently than in the past. However, it is not consistent, or significant to most people not living with the disease on a daily basis.

His problem solving skills do not seem any better, but his steady decline in short term memory appears to have been slowed. I'm not sure how his "status" is reflected on the mini mental tests - his next doc appointment is scheduled next week. Of course, wanting to see an improvement clouds my objectivity as well. I am the only one in my caregiver support group involved in the trial that feels they see an improvement. At least two others don't see any improvement. Again, none of us know who is on the real drug.

Dad's on namenda and galantamine as well. We started him on namenda before it was released here in the states. I think these drugs have been helpful in slowing the progression of the disease. His memory problems became noticeable about five years ago. Hopefully flurizan's efficacy will be validated and it will be another drug to add to the Alzheimer's drug "cocktail."

Hello Zirdob , I am not very good with computers so please forgive me. My husband is into the flurizan drug trial by 5 months. I too believe he is on the real thing. He improved the first month quite noticably but since then I'm not sure. He does remember things he would not have before but it's spotty? Hope runs eternal! I understand it is very slow reacting, so I am still hoping for improvement?
Glad to here someone else is seeing the same things I am!

quote:

Originally posted by Zirdob:
I'm new to this message board, so hopefully this topic is appropriate here and hasn't been addressed extensively elsewhere. My dad has been in the Phase III Myriad Genetics flurizan study for about 10 months. It is a double blind study, so we don't really know if he is on the drug or just a placebo.

I do think that dad is on the trial drug and would be interested to know if others involved in the study were experiencing similar changes in their loved one's functioning. They aren't big changes, but significant from my perspective. For example, today he remembered he was working on a puzzle yesterday, and said he wanted to work on it again today. He fell a few days ago, and rather than wondering why he is sore, he brought up that he fell a couple days ago. He will occasionally remember where he ate when asked a few hours later - before he would always forget. In general I've noticed an increase in his ability to recall recent events more frequently than in the past. However, it is not consistent, or significant to most people not living with the disease on a daily basis.

His problem solving skills do not seem any better, but his steady decline in short term memory appears to have been slowed. I'm not sure how his "status" is reflected on the mini mental tests - his next doc appointment is scheduled next week. Of course, wanting to see an improvement clouds my objectivity as well. I am the only one in my caregiver support group involved in the trial that feels they see an improvement. At least two others don't see any improvement. Again, none of us know who is on the real drug.

Dad's on namenda and galantamine as well. We started him on namenda before it was released here in the states. I think these drugs have been helpful in slowing the progression of the disease. His memory problems became noticeable about five years ago. Hopefully flurizan's efficacy will be validated and it will be another drug to add to the Alzheimer's drug "cocktail."

Anyone else having positive results from flurizan? It has been a few months since my last post and I continue to see improvement in my dad's short term memory. Nothing huge, but simple things like frequently being able to remember what he ate a few hours earlier, etc. He will still repeat himself and hasn't had a significant improvement in his problem solving skills.

Recently he was able to remember a new therapist's name a few days later - which I never thought would be possible. We still don't know if he is on the drug or a placebo - but it looks promising.

I'd like to hear how others are doing that are out of the controlled study phase and are for sure receiving the real drug. I'm hopeful that the progression of the disease can be slowed significantly. Dad's been in the double blind study about 14 months now. If he is really on flurizan, it appears to be a helpful addition to the currently prescribed meds.

A quick update on Dad's progress to go with this press release from Myriad that I copied.

Later this month Dad will hit his 17th month enrollment date. His MMSE of 21 remained unchanged after 12 months - Good sign! Some improvement in short term recall, but basically his condition seems to have stabilized without any dramatic changes. A little better with ADL skills but still the occasional weird action/thought typical of his stage in the disease. (Of course, we don't know if dad is on the drug or placebo. His particular results still could be based on other factors.)

Hopefully the other AD drugs in the pipeline will show equal promise/results.



Myriad's July 5 Release

Drug development programs are promising

The Alzheimer's Disease Program: In drug development, the company is also making steady progress. Flurizan, its lead candidate for Alzheimer's disease, is designed to lower the levels of amyloid beta-42, one of the primary contributors to plaque that accumulates in the brain of Alzheimer's disease patients. Flurizan is currently under two pivotal phase III trials.

The company completed phase II trials with Flurizan in March 2005. The final results, reported in June 2005, demonstrated that Flurizan was well tolerated and beneficial in patients with mild Alzheimer's disease but not so beneficial in patients with moderate AD. Flurizan also demonstrated a 34% improvement with respect to the mild AD patients daily living activities.

On March 12, 2006, Myriad announced the data from its 21-month phase II follow-on study of Flurizan in patients with mild Alzheimer's disease at the 19th annual meeting of the American Association of Geriatric Psychiatry. The data suggested that study participants on 800 mg BID of Flurizan continued to demonstrate increasing benefit through month 21 in the area of cognition and memory loss and that they maintained more of their global function and activities of daily living than those on 400 mg BID of Flurizan or than the projected placebo. The data also suggested that during the follow-on period from months 12 to 21, the benefit of Flurizan on the measures of Alzheimer's disease increased in terms of both effect size and significance, the longer patients remained on Flurizan.

As measured by the performance of activities of daily living (ADCS-ADL), by patients taking 800 mg of Flurizan BID, there was a 52% effect size compared with the projected slope of the placebo at 21 months (p=0.029). In terms of the patient's global function at 21 months, the CDR-sb scale showed a 75% effect size (p=0.0007), also significant. These data suggest that there is a substantial benefit from Flurizan on activities of daily living and global function, and that the benefit is increasing over time.

The effect of Flurizan in improving cognitive decline, as measured on the ADAS-cog scale, has also increased, as shown by the effect size of 60% at 21 months (p=0.096). All three of the measures suggest sustained benefit from Flurizan in patients with mild Alzheimer's disease. The above results were further supported by the continued 24-month follow-on data of the phase II trial which was presented at the 10th International Conference on Alzheimer's Disease and Related Disorders, in Madrid, Spain on July 19, 2006. The data demonstrated the continued improvement in the area of cognition, global function and daily living activities in patients with mild Alzheimer's disease on 800 mg Flurizan.

On March 5, 2007, the company reported additional data from the above completed phase II trial at the annual meeting of the American Association for Geriatric Psychiatry [AAGP]. New data demonstrated that Flurizan may be capable of not only of slowing the decline of Alzheimer's disease, but of halting the disease in its tracks. In this study, many patients with Alzheimer's disease got no worse over two full years, and in some cases, patients treated with Flurizan appear to have improved. Overall, 42% of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living, compared to 10% of patients on placebo. The vast majority of patients in this Phase II study, approximately 94% at the time of enrollment, were receiving stable doses of acetylcholinesterase inhibitors, which are FDA-approved drugs for symptomatic treatment of Alzheimer's disease. Thus, the benefits of Flurizan observed in these patients were over and above the current standard of care.

Since Flurizan appears to slow the biological progression of the disease, this is an exciting and novel finding, and if replicated in the ongoing phase III trials will be extraordinarily important.

Based on the phase II results, and after holding discussions with the FDA, the company decided to modify the protocol of the phase III trial in the US, initiated in January 2005, to focus more on the mild AD indication. In this modified trial, the company will evaluate a twice daily dosage of 800 mg Flurizan on mild AD patients.

On August 22, 2006, the company announced the completion of about 1600 patient enrollment for this trial. We expect the company to file in late 2007 if results are positive, followed by an approval in 2008. Patient data will be analyzed after 12 months, but patients will remain on treatment for 18 months to allow for additional follow up data. All patients in the U.S. phase III study are permitted to take current standard of care medicines in addition to Flurizan or placebo. Therefore, benefits seen in the trials are over and above any benefit provided by the current standard of care drugs.

Myriad also started to enroll a global phase III trial in July 2006 in patients with mild Alzheimer's disease in Italy, France, Germany, Spain, Sweden, Switzerland, the United Kingdom, Netherlands, Belgium, Canada and Denmark. The trial will enroll approximately 800 participants into two groups, 800 mg twice daily and placebo, and the participants will receive treatment for 18-months. The primary endpoints in the global trial are identical to those of the U.S. phase III trial and are the same as two of the three endpoints in the phase II study. The trial is designed to meet the requirements of the European Agency for the Evaluation of Medicinal Products [EMEA] for marketing approval of Flurizan in Europe. In March 2007, the company announced the completion of enrollment of the global phase III trial. EU filing could come as early as in the 1H08, followed by approval in 2009.

Management stated that they will look for a partner to commercialize Flurizan once phase III data becomes available. We are optimistic on this compound because current Alzheimer's drugs do not slow the progression of the disease, they only treat the symptoms. If successful, Flurizan could be the first drug approved by the FDA for mild Alzheimer's that has a preventative indication.

Zirdob:

That is good news! I tried to get my husband in the trial but was turned down because he was to young. There are several good drugs that will hopefully be coming to market within the next 2-3 years.

Please keep us posted.

Trish

Zirdob, have you found out yet if your dad was on the real stuff? My wife's been in the Phase III for 15 months with very little deterioration in her test scores. She is also taking an aricept/namenda combination and I suspect she has the real drug. Interestingly though, she thinks she has the placebo. She is 64 and was diagnosed 4 years ago.

Promising, very promising. More work to do, though.

My husband completed the 18-month Phase III Flurizan trial, and is now on open label (i.e. definitely getting the drug). We had started with Alzehmed, but he had severe gastric reactions and we had to abandon that trial. We then went to Flurizan. I believe he was getting the drug during the trial because the decline continued, but at a slow pace. (This is all so subjective, I understand.) I've also gone to the Exelon patch, but this time devised a questionnaire to see if there was a more objective way to judge improvement.

None of these treatment efforts produced a noticeable bump up in cognition. The best I can say, not having a benchmark for comparison, is that they've worked to slow the deterioration. The deterioration continues, however -- and it is truly the saddest thing to live with and through. By the way, I never told my husband that he has AD -- in my judgment that would kill his spirit, and his spirit is of utmost importance to him as well as to me.

Hi, My husband was on Phase III from Oct 2005-April 2007. We thought he was on placebo, because he continued to do worse on his MMSE and also was slowly declining. Then he went into the 30 day clean out phase and really went down hill! He started on the real Flurizan in June, 2007 and did appear to improve. He said he felt he was doing better and wanted to start driving again!! His doctor at the drug trial said, he should not drive anything, even a golf cart! He continues to decline. His MMSE is 7 out of 30, because he has difficulty saying words. Nancy

Back again. Sorry for the long time between posts. We had a toilet overflow that led to an extended nightmare remodel job... My computer and the rest of the house was out of order for months.

Dad continues to do well in the open label period of the Flurizan Phase III trial. His MMSE only dropped a point after 18 months. I think it is at 20. (It is easy to gain or lose a few points.) I haven't noticed any significant decline in the past two years - just slight improvement.

In about three months we should have another MMSE and I will let you all know how it goes.

One other new member of my caregiver support group has had similar positive results. Two or three others in the study noticed no changes, but if their loved one was on the placebo, their decline made any positive changes in the open label period more difficult to identify. One has, however, improved, even after having declined throughout the controlled phase.

It appears that if working, it does best the earlier it is taken. There are so many promising treatments on the horizon, I hope that this truly proves to be a success and not that my dad and a few others are just lucky... (I hate raising false hopes, this disease is so ugly and challenging.)

My best to all.

Bill

"All I really need is a song in my heart, food in my belly and love in my family." Raffi

Hi Bill, thanks for the come back. That must have been quite a house project. Does your Dad live with you? Where are you located? Was your support group organized by the drug trial people?
We are just north of Charlotte and the drug trial is in Duke - 2 hours away. Gale is 71 and was diagnosed in 2002. I agree that the Flurizan would be better for the early stages. Nancy

Bill I'm so glad you asked for help and got some. We have to take care of ourselves. My family is not in the area. We moved to NC because our daughter was here and as normal in today's world, she has moved to Atlanta - 5 hours away. Our other children are in CA and Tx. Our CA daughter and granddaughter were just here for a visit. What joy. The computer with email and these message boards sure do help. I am a facilitator for a support group. We bring our spouse and then they meet in one room and we are in a separate room. Gale is able to add to conversations a little better now, but often looses the key word that he is talking about. I am getting good at guessing. He has a lot of Apraxia, so is unable to dress himself. Even if I tell him to lift his leg, he hears me, but the message never gets to the nerves and muscles. We do try to go for a walk each day. We are a block from a nice walking park. Enough for now. Nancy

I was doing some research online about Alzheimer's and cam upon this discussion board. First let me say, how moved I am and inspired about what I'm reading. I have a special interest in this disease. I recently lost my grandfather after a long battle with it. I also work for a drug company and have for almost 10 years now, selling a leading drug for the disease. I know what devastating effects it can have on not only the patient, but the caregiver and as a rep, I give a voice to that everyday with the physicians that I work with. I carry around a picture of my grandfather as a reminder that I am helping another family have- another christmas, another birthday and another memory that they otherwise wouldn't have had. To have a drug in development or many drugs in development to help preserve function and cognition is beyond words and I am just so promised by reading this, that if caught early enough, those with this devestating disease and their loved ones will be spared from the grasp of it. You guys serve as a reminder to me that no matter what and above all else, we need to get these patients diagnosed much earlier. So often they come in after it has progressed. I am committed to doing whatever I can for the fight against alzhiemer's, which in just short order will become an epidemic if not already. Thank you so much for your inspiration and God speed to all of you going through this. My thoughts are with you and them.

My husband, Gale, is having great difficulty swollowing pills and these Flurizan are huge - and he is on two of them morning and evening. Many times, he will spit them out after a few minutes. Any suggestions? I did grind one tonight and put it into his applesauce. He is very suspicious, so it must really be disguised. I really debate if it is of value to continue. He is also on Exelon and Nemenda. His MMSE is between 7 and 5. I do think it helps keeping him more "with it". He wants to get his own car. (He has not driven since 2005.) Being a lawyer, he can be very argumentative. How is it going with all of you? Oh yes, Gale is on the real drug now - open label. Take care. Nancy

Back again - I need to stay more current on this message board! Hopefully Nancy has figured out a way for Gale to swallow the pills. They are quite large. There must be some tips discussed in the other forums.

Dad continues to be stable and has not shown any significant signs of decline. He may be slightly harder to re-direct, but it depends a lot on how I interact with him.

His six month follow-up in the open label period went well. His MMSE stayed the same. Again, I don't know if it is the Flurizan, or dad's unique make-up, but not declining in over two years seems pretty remarkable to me. I think the earlier you can get a loved one on this and other AZ drugs, the better. I still favor the drug "cocktail" approach.

There are so many promising drugs and treatments in the pipeline - I hope this will be just one of many future options.

Take care!

+++++++++++++++++

The following is an article found on the web:

Myriad Genetics: Flurizan hot on the heels of Neurochem's Alzhemed
22nd March 2007
By Martin Adams

Myriad Genetics makes progress with second phase III trial of Flurizan in Alzheimer's
Myriad Genetics has completed enrollment in the ActEarliAD, global phase III clinical trial of Flurizan for the treatment of Alzheimer's disease. The rapid clinical progress of Flurizan is crucial given that its rival, Neurochem's Alzhemed, has already finished its phase III trial, and both drugs are now racing to become the first disease-modifying therapy to market.

ActEarliAD is a multinational, randomized, double-blind, placebo-controlled study of Flurizan (tarenflurbil) in over 800 patients with mild Alzheimer's disease (AD). The 18-month study assesses Flurizan 800mg twice daily or placebo, with patients attending periodic physician visits for analysis of their performance on memory, cognition and behavioral tests.

The two primary clinical endpoints are the change in cognitive decline and function, as measured by the AD Assessment Scale-cognitive subscale, and changes in activities of daily living, as measured by the AD Cooperative Study-Activities of Daily Living inventory.

AD is a chronic progressive neurodegenerative disease that adversely affects higher cortical functions including memory, thinking and orientation. The disease mainly affects the elderly and has an estimated prevalence rate of 5.1 million in the seven major markets.

A treatment that can actively reverse, prevent, or cure AD currently remains the greatest unmet need. Earlier in March 2007, Myriad presented 24-month phase II results of Flurizan at the annual meeting of American Association for Geriatric Psychiatry.

Overall, 42% of patients on Flurizan showed improvement or no decline in one or more of the three primary endpoints of cognition, global function and activities of daily living. If approved by the FDA and EMEA, the disease-modifying potential of Flurizan will represent a crucial breakthrough in the treatment of AD, and will offer considerable hope to patients and their families.

With the exclusion of moderate AD patients and the sole use of the highest dose, Myriad is providing greater weight to allow demonstration of Flurizan's benefits than the original trial designs allowed. Datamonitor expects results from the global phase III trial to be announced towards the end of 2008 and predicts US market launch in late 2009.

The successful launch of Neurochem's Alzhemed in early 2009 is likely to restrict Flurizan's impact upon entering the market. However, Datamonitor forecasts Flurizan to achieve global sales of $932 million by 2014, with the novel mechanism of action expecting to see the drug being used in combination with the acetylcholine esterase inhibitors, such as the current market leader, Aricept (donepezil, Eisai/Pfizer), particularly when generic versions of these drugs reach the market.

What a bummer! Dad is still doing well, no decline in MMSE, but apparently not as a result of Flurizan. At least dad got great care and monitoring for the past couple years. I was hoping that he would be spared the typical end game of this horrible disease. I'll stay tuned to the other promising drugs/treatments. Sorry - I hope I didn't raise any false hopes.



++++++++++++++++++++++++++++++++++++++

Myriad Genetics Reports Results of U.S. Phase 3 Trial of Flurizan™ in Alzheimer's Disease
Flurizan Fails to Achieve Significance on Either Co-Primary Endpoint; Company Has Decided to Discontinue Its Development of Flurizan
SALT LAKE CITY, UT, Jun 30, 2008 (MARKET WIRE via COMTEX News Network) -- Myriad Genetics, Inc. (NASDAQ: MYGN) today announced results of the Act-Earli-AD trial, an 18-month Phase 3 study of Flurizan (tarenflurbil) in patients with mild Alzheimer's disease. The study did not achieve statistical significance on either of its primary endpoints -- cognition and activities of daily living.

"We are disappointed that Flurizan failed to achieve significance in this study, and we will now discontinue development of this compound," said Peter Meldrum, President and Chief Executive Officer of Myriad Genetics, Inc. "The discontinuation of Flurizan will reduce our pharmaceutical development spend substantially and should enable Myriad to achieve profitability next year, ending June 30, 2009."

During fiscal 2008, Myriad spent approximately $60 million on development of Flurizan. The remaining expenses to wrap up its Flurizan program are projected to be approximately $8 million in total, spread primarily over the next two fiscal quarters.

Dear Friends, Gale had been in serious decline for the past several months. We had stopped the Flurizan the middle of May.
He had a UTI and then pneumonia, during the first week of June and lost his ability to walk. He was admitted to Hospice on June 17th and on the 20th, the Hospice doctor told me that he had just a week or two to live. I was in total shock, but appreciated the warning. Gale was in a hospital bed at home during the last week before he passed on Wednesday, June 25th. It was a blessing for to be free of the horrible disease, Alzheimer's. He was surrounded by his family.
Thank you for all your support. Nancy

Nancy - I'm so sorry for your loss. As difficult as it is to deal with this disease, it is still very hard to lose a loved one. Remember him at his best and know that all you did as a spouse and caregiver is a true sign of your love and commitment. Take care! Bill

My father was on a study with flurizan, he was doing very well. They immediately stopped anyone involved in the study from taking the drug due to some of the participants having very bad side effects. Within 2 weeks of my father stopping the medication he DRASTICALLY went down hill and is currently in a nursing home. Unable to walk, sleep, talk and is completely unaware of his surroundings and existance. If anyone has any idea what is going on, please write.

Dear Malicio --

My husband was also on Flurizan until early this year. They bounced him out because he developed lung cancer and was on chemo. (The lung cancer is NOT considered a possible side effect of Flurizan -- but Myriad wants to play it safe in any event.)

I also thought that Flurizan was helping to slow the disease. My husband's MMSE remained constant for over a year, and then showed some decline.

The Flurizan trial was stopped, unfortunately, because it did not show a statistical significant benefit to those participating in the trials. I don't think it was stopped because of "very bad side effects" at all.

My husband is now using Enbrel (see separate thread) and is stable. If you can spend a little time perusing the other threads, you will find other options. The other options help -- but, unfortunately, the "cure" for Alzheimer's remains an elusive goal.

But still keeping hopes up