As I’ve mentioned before I’m in the process of attempting to get Charlie enrolled in the Elan Phase III clinical trial. He made it through the phone interview. A week ago we drove to Raleigh for additional screening and should soon know if he qualifies. I’m really excited about the potential of Elan/Wyeth’s Bapineuzumab as a tool in fighting Alzheimer’s.

In a clinical trial the drug is free, the work-ups are free and thorough, and participants are continually screened for side effects in a closely monitored professional environment. In the Bapineuzumab clinical trial...Participants are PAID a nominal amount of money for their time and trouble.

Phase III of the Elan clinical trial of bapineuzumab is currently enrolling. A Phase II Wyeth clinical trial using a different delivery system for bapineuzumab is planned but not yet recruiting. For more information go to: www.clinicaltrials.gov

Please...If anyone else is thinking of or attempting to enroll...Has successfully enrolled....or...Has participated in prior clinical trials post their thoughts and experiences here.

A fellow forum member posted some questions on the Enbrel thread. I thought that his questions and my answers would be a valid contribution to this thread and copied and pasted my reply below. If anyone has participated in a clinical trial, I would especially welcome their sharing experiences. (especially on the disclosure issue)
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IRA---Thought I would address some points brought up in your post before moving on to our household ADLs.

“There is also the possibility, 25%?, that Charlie gets the placebo and not the actual drug too, but it is probably worth the chance.”

The placebo issue is a good one. In fact...It is partially responsible for my not attempting to enroll Charlie in prior clinical trials. Because of the Enbrel thread, I’ve come to the conclusion that unless people participate in clinical trials new treatment methods will never be main-streamed. Charlie may get a placebo...but...His participation in a clinical trial may provide data that can help his children and grandchildren.

“If you enroll in the trial, and Charlie does not appear to be benefiting after several months, are you able to drop out?”

Slavery was outlawed years ago...I doubt if anyone can be forced to continue to participate in anything. If Charlie shows not improvement after months (and is still basically holding), I would probably opt to continue because I believe in the value of the data collected.

“Do participants have to sign some type of non-disclosure agreement?... Perhaps these participants would be eliminated from the trial and lose out on use of the drug after the trial?”

I honestly cannot answer this question. If Charlie does qualify, a disclosure agreement would probably not rule out my returning to answer this.

Skericheri:

First I wanted to tell you Charlie is lucky to have you as his caregiver and your love for him shows through your posts.

I have been researching this drug for over a year. I've invested in both Elan & Wythe because I think they have a good shot at stopping this disease with the many drugs they seperatly (or together) in clinical trials. I can't believe some of the false information posted on this website regarding these two companies.

My husband will go in for screening for the AAB-001 study this coming week. I can tell you that those who were enrolled in phase II are now eligable for the open label. Phase II results from about 240 patients will be announced mid-late June. If they are favorable then Elan/Wythe needs six months of safety on 1000 patients to file for approval from the FDA. This may happen mid 2009.

Good luck and let me know how it goes.

That's great!

Thanks for starting this thread.

Tom is also going to be interviewed for phase III Bapineuzumab trial. As you have stated, 25% chance for placebo is worth the chance.

Having worked with clinical trials, know that you can opt out at any time. Staying with the trial allows you to receive the drug as soon as trial is completed.

Would love to know if anyone out there has been involved with the phase II trials and can report on their progress.

While the buzz has been favorable, it would be great to hear from someone who has been involved.

From the 05/17 03:11 PM post by RHS on Page 25 of the Enbrel for Alzheimer’s thread.
“If you want info on test results or MRI's you have to ask. They won't volunteer it.”

The individual dealing with us during the screening process was kind enough to share Charlie’s MMSE without being asked. I’m not ashamed to admit that when it comes to most medical matters, I’m totally ignorant.

Would someone with more knowledge give me some thoughts about what questions to ask?

Thanks for starting this discussion! For so many, the different trials are just so confusing. Could someone with some experience or research in this area explain the difference between the Elan and Wyeth trials?

I don't know about tests. I would guess that potential side effects would be lined up with appropriate tests to monitor results - and that MRI or other tests would monitor the fluid retention issue and/or bleeding. Out of my league. I would have a Health Care Surrogate Form in hand to force disclosure of all tests and a liaison with one individal empowered to give immediate answers. So easy to get jerked around.

Pat

All tests taken by patients are to be shared. Afterall, your body, your tests, no secrets. Healthcare givers (ashamed to say) can have poor interpersonal skills like any other profession. Do not expect them to willingly share information, they often assume that since they know, you know.

In a clinical trial, the only thing they cannot share is whether you are on a placebo or not. They do not even know, that's the beauty of a double blind study being scientifically accepted. No one has a clue who is getting what, eliminates the "placebo effect". All other test results are to be shared. Do not hesitate to ask, and if necessary demand results in writing.

From what I have read (please go to gov site for details) difference between the Elan/Wyeth trials is the route of injection..intravenous infusion (into the vein) versus subcutaneous (just under the skin) and different doses of the AAB-001, Bapineuzumab.

[quote]www.clinicaltrials.gov[/quote]

Sorry if you missed this in the above post...the details of the study.

Noticed the following differences:

Delivery: Subcutaneously (an injection?)
Dosing Schedule: Weekly
Under primary outcome measures: "Designated as safety issue: Yes"

Have another questions:
If this is the same stuff, why are they calling it a Phase II Clinical Trail?
Is there any information on Phase I?

Timed out before I could edit.

Have questions:
If this is the same stuff, why are they calling it a Phase II Clinical Trial?
Is there any information on Phase I?

You can have many different trials on a single drug. As noticed on the clinical trials website, the protocols are different. The intravenous route, IV, places the AAB-001 directly into the blood stream, Phase III.

The subcutaneous injection, subQ, is an injection under the skin and takes a while to be absorbed. Phase II.

The different dosages are other protocols, which require separate trials.

While I have NO knowledge of any the phase I trials, my assumption is that since the AAB-001, Bapineuzumab appeared to work, the researchers are already looking to see if there is any difference in effectiveness between doing it IV every 13 weeks or every week subQ. Also trying to discern what dose works best.

As a refresher, this is copied from alz wbsite;

Phase I trials, the first stage of human testing, typically enroll fewer than 100 volunteers. These studies are primarily concerned with assessing risks and side effects associated with a drug.

Phase II trials enroll up to a few hundred volunteers with the condition the drug is designed to treat. These studies provide further information about safety and focus on determining the best dose of a drug. Scientists also watch for signs of effectiveness, but Phase II trials are generally too small to provide clear evidence about benefit.

Phase III trials enroll several hundred to thousands of volunteers, often at multiple study sites nationwide. They provide the chief evidence for safety and effectiveness that the FDA will consider in deciding whether to approve a drug.

Hope this helps.

This mornings news;

"Thursday, Elan said it and its joint venture partner on Alzheimer's Wyeth (WYE) continue to enroll patients into four Phase III clinical studies of AAB-001.

Wyeth has declined to comment on whether or not any statistically significant findings on cognition could be expected. Wyeth also indicated that several dozen patients had already enrolled in the U.S. arms of the Phase III trials being run by Elan.

Most analysts say that Elan and investors alike have big hopes for AAB-001, which they say has the potential to be a blockbuster drug and a key share driver.

They say the next catalyst for the company is not on current business, but on future potential with the release of the AAB-001 Phase II data mid-year.

"Although Wyeth had previously indicated this would be early July, consensus now is that it will be in June, with the full data to be presented at the International Conference on Alzheimer's Disease at the end of July," said Goodbody's Hunter.

"Speculation on the nature of the data and the actual data, when released, will drive the share price in the near term rather than historic results," he added.

Today I learned that Charlie failed to qualify for the Elan Phase III trials. I am more than disappointed...but...I do understand their logic as well as their right to make the decision.

Will those who make the 'final cut', please continue to post.

Skericheri:

Sorry about Charlie. There are several others trials from Elan that will be in phase II & III. Will he possibly qualify for them? Baxter is in phase II and will be starting a phase III trial soon. I have heard good things about this drug. Let me know if you need additional info.

We passed the first hurdel. I will post if hubby gets in.

Thanks Cherie for starting this thread and hello to fellow Georgian TKB. We did get an appointment in West Palm for my father's screening visit on June 9th. If he passes the MMSE, then I will fly down in July for the first infusion. Still worried about the MMSE as he scored a 19 last month and that was a good day. If he is having a bad day, he won't qualify. I do have a question about the study that I'm not clear about. I did ask the nurse clinician for the Elan Study about the placebo and 3 different doses of Bap. I was under the assumption from our discussion that the 3 doses of Bap. would also be blind...so therefore I assumed that the study would be a 50/50 chance of placebo. Can someone claify?
Erin

Eoneill:

The chance of getting the drug is 60% as told to me this week by the research nurse. I believe there is a total of 6 infusions spaced at 13 weeks apart. You could ask if he does not pass the MMSE if they would let you take it over. Our facility got written permission from Elan to allow that to happen if needed. Make sure he gets a good night's rest the night before testing. You may also do practice MMSE tests on him which may help.

I'm assuming he lives in Florida. If not did you know that there will be 3 sites in Atlanta?

Good luck to you & I hope he gets in!

Hi Erin;

A blinded study means that all patients, and research staff, will not know whether they are getting placebo or if the med, what dose of Bapineuzumab.

We are still anxiously waiting to hear from the research nurse.

TKB,
Thanks for the info. I'm aware of the MS Center in Atlanta and Dekalb Neuro doing the study. What is the 3rd site? My father is in an ALF in Florida so it makes sense to keep him there at this point. Please explain more about getting permission from Elan to use the drug. Does that mean you can use the drug and not be part of the study and pay for your own medical tests and MRI's? We are practicing with the MMSE test but my father's short term memory is only a few seconds...so the practice is not going so well. He can't remember the town he lives in and all the practicing doesn't help. Any suggestions?
Erin
ekennedy10@cs.com

Erin:

Emory University is also doing the study but have not advertised on clinical trials yet. We did not get permission to use the drug and I'm sorry for the confusion. My husband's MMSE score was to high at 27.The nurse got permission to retest later this year to see if he would qualify. When he went in for prescreening his MMSE was 26 which made him eligable for enrollment but we still have more hurdles to overcome before he can receive the placebo or the drug.

I would suggest that you would continue to work with your father. Is there a time where he is more alert perhaps in the morning or afternoon? If so ask the research nurse to schedule his appointment at that time. The facility in Atlanta have been very accomadating.

tkb,
Thanks for the info. Emory works for me. Do you have a contact and phone number? At some point it may make sense to move my father here. We will continue to pursue the study in West Palm but it's nice to know that we have options here in Atlanta to continue it.
Erin

We were told today that we have a 50% chance of being included in the AAB-001 trial. Tom has a small arachnoid cyst seen on his MRIs therefore will probably be ineligible. The center is working to get him included but it looks grim.

It just seems ironic that I have worked so hard to get folks enrolled in this study, as well as connected with doctors for alternative treatments and we may be on another hunt.

Sorry for the whining I just needed to vent.

Underscore what Shericheri wrote...please continue to post as we will all be interested in the results.

While checking out the Wyeth message board at Investor Village.com I came across a post that appeared to provide the answers to the questions raised in my 05/18 post.
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"PII trials require fewer participants. This trial is done in partnership with Elan. The method of delivery is cheaper, but in getting bapineuzumab most will likely start with infusions. They're bothering with subcutaneous injections, because the FEDs & insurance companies would go broke if ALL the patients GOT infusions ALL the time.

In Elan's last annual report, they show a picture of a mouse's artery before & after bapineuzumab. The plaque removal is extensive and may cause adverse events like strokes or vasogenic edema (extra fluid in the brain) or worse (especially in APOE4 carriers). Thus, patients start out with hospital infusions for a year or so, until the risk of adverse events is diminished. Then they'll go onto less expensive home injections.

Dosing may start out with less concentrated doses in APOE4 carriers to minimize AE risk. It's hard to take a lifetime of arterial amyloid plaque buildup and get rid of it in an hour. Elan's Dr. Schenk & crew are great, but they don't walk on water, yet."

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Sorry to learn about Tom's potential ineligibility for the BAP trial. I hope that someone's loved one will actually qualify for the BAP clinical trials and will take the time to keep us informed. The BAP trials look as if they have a great deal of potential.

Well the news looks good re Bapineuzumab.

Check this link http://www.pharmatimes.com/WorldNews/article.aspx?id=1371

Stress what Skericheri wrote...when your LO is enrolled please post here and let us know what is happening.

Good luck to all!

Ger,
Do you have any comments on the results of Elan's Phase 2 results for the Apoe Carriers?

My father is having his MRI done for the Elan Study today. Will let you know if he qualifies for the study. He is an Apoe carrier. The Elan Phase 2 results posted yesterday are not encouraging for Apoe carriers. Is there anyway to combine the 2 threads for the Elan Study? I hate to go to both threads when the topic is the same. Does anyone know if the site admin. can combine the threads?
Erin
ekennedy10@cs.com