My DH neurologist has recommended him for a research trial. It is with Lily - placebo for 6 months, then everyone gets the real med after that for a year. We go tomorrow for an evaluation which he has to take in order to meet their critiera. Does this trial sound familiar to anyone. I don't think he will qualify as he is very high functioning especially when he knows he is being tested. His problems are primarily behavior, anger, reasoning or lack of, and memory. He is like a piece of Swiss cheese, he is real solid until we reach one of those holes. I told her that a true test would be to get him in a car and then say something to make him mad and watch him try to jump out of the car.
You would have to tell us the name of the drug for us to know which trial you are referring to. The way it usually works is that 1/2 of the participants get the drug, and 1/2 get the placebo. (Some trials are 60%/40%, rather than 50/50) AFTER the trial period - 6 months or a year or whatever the protocol set by the drug company - IF the drug passes the criteria set by the drug company, and they feel it is helping enough people, they will then give it to everyone who was in the trial, including those who got the placebo. The one you refer to is a year; others are 18 months. Then, if approved, the drug goes on the open market.
Can someone tell me more about trials? I have been very afraid to even try to find one for my DH. I noticed a relatively quick slowing and stablizing of his deterioration when the Namenda and Aricept kicked in when he was first diagosed about 18 months ago. He seems to be deteriorating fast enough as it is. The thought of him receiving a placebo and risking an even quicker deterioration is more than I can handle.
There is a lengthy discussion topic on trials -"Drug Trials/Vaccine trials". You can find it by typing it into "search" at the top of this board.
First, you need to find a Memory Disorders Clinic in your area (home page - www.thealzheimerspouse.com - left side - scroll down to "find a memory disorder clinic in your area) that is doing trials. They will evaluate your husband, medically and cognitively, to determine if he is eligible for a trial. The neurologist in charge will determine which trial he feels will benefit your husband.
I fully understand your feeling about wasting time with a placebo, but if you decide to be in a trial, that's the risk you take. Sid and I figured it this way - he would most likely decline in the 12-18 months of the trial anyway, so why not give him a chance at improvement during that time, but that was just our opinion. Which doesn't matter now anyway, since they dropped him from the trial.
Stephanie, a placebo is just a "sugar pill". It wouldn't do any harm to your husband. It would simply mean that he wasn't getting the investigational new drug (IND).
If you feel comfortable telling me where you live, and remind me about your husband's age, I can see what trials are in your area.
Joan, some clinical trials are set up with an "open label" stage already incorporated into the test protocol. That is, they do NOT wait to crunch the numbers from the double-blind placebo stage before deciding whether to go forward with the open-label stage.
In the placebo stage, the patients who receive placebo serve as "controls" or a "baseline" against which those who receive the drug are compared. However, as we all know, different patients respond differently to a drug. The open-label stage makes it possible to use the patient himself as his own control or baseline.
Eli Lilly is currently recruiting for two trials, both of which are on the same drug, and both of which have an open-label stage. The drug, which goes only by a code right now (LY450139), is a gamma secretase inhibitor. Quote from one of the trial descriptions (they're very similar, I didn't pay attention to the differences between them):
Alzheimer's disease (AD) is a fatal degenerative disease of the brain for which there is no known cure. AD causes brain cells to die. AD is thought to be caused by an excess of Beta amyloid (Aβ), a sticky protein in the brain that forms amyloid plaques. At autopsy, AD patients are required to have amyloid plaques in the brain in order to have a definitive diagnosis of AD. Inhibiting the enzyme γ-secretase inhibits the production of (Aβ) as measured in blood and spinal fluid in humans tested thus far and in blood, spinal fluid and brain in animals tested thus far. This study will use several different tests to measure the effect of LY450139 on both (Aβ)and amyloid plaques for some patients. The build up of amyloid plaques will be measured by a new brain scan that can take a picture of amyloid plaques in the brain. Other tests will attempt to measure the overall function of the brain and brain size in some patients. In this trial patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. In other words, all patients will eventually receive active drug. Each patient's participation will last approximately 2 years. Patients taking approved AD medications may participate in this study and continue taking these medications during the study. All patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.
I realize the placebo is harmless, I guess I was afraid they'd make him get off of his Namenda and/or Aricept in order to participate. We live in south Louisiana. Nearest large cities are New Orleans and Baton Rouge.
We went for DH eval today and they accepted him into the trial with Lily. The "name" of the med is is LY450139 a y-Secretase Inhibitor Phase 3. He became VERY interested when they told him they would pay him to participate. He interested and hopes to start next week. I have to sift through all of the info they sent home with us first. The program sounded like they give a lot of support and contact. That is something that has been missing for us and we welcome getting to know more about this awful disease.
The name of the group running this is Axiom Clinical Research of Florida, 2919 Swann Avenue 105A, Tampa, Florida 33609 813/353-9613 in case any one else is interested. It is headed by Dr. Susan Steen, my DH's Neurologist. Looks like we will be off on another adventure.
According to the section on my home page on Memory Disorder Clinics, the one listed for Louisiana is http://www.thibodaux.com/ You could call them and ask if they are doing any AD trials, and if they are not, could they direct you to a clinic in Louisiana that is doing trials.
They don't take patients off of their meds. If a patient is on a med that is excluded from the trial, then the patient is not allowed to enroll.
Not much going on in Louisiana. There are two Phase III clinical trials for bapineuzumab (that's the one Joan's husband was in) which will accept patients 50-88 years old on stable doses of Aricept and Namenda. (The two trials look identical, don't know what the differences are.)
Identification numbers are: NCT00574132 and NCT00575055
Contact: Study Coordinator 1-866-446-5463 (I think this is Yale, but not sure)
The trials are in Lake Charles and Shreveport.
Lake Charles Clinical Trials 2770 3rd Avenue, Suite 340 Lake Charles, LA 70601 USA Phone: 337-494-3266 Fax: 337-494-2089
LSU Health Sciences Center 1501 Kings Hwy. Shreveport, LA 71103-4228
Pat Jinkins, Coordinator Phone: (318) 813-1481 Email:pjinki@lsuhsc.edu this contact info is for people who want to run a trial, but I assume you could find out about enrolling here, too
* Diagnosis of probable AD * Age from 50 to less than 89 * Mini-Mental Status Exam score of 16-26 inclusive * Brain magnetic resonance imaging (MRI) scan consistent with the diagnosis of AD * Stable doses of medications (cholinesterase inhibitors and memantine allowed) * Caregiver able to attend all clinic visits with patient
Exclusion Criteria:
* Significant neurological disease other than AD * Major psychiatric disorder * Significant systemic illness * History of stroke or seizure, autoimmune disease, myocardial infarction within the last 2 years * Smoking greater than 20 cigarettes per day * Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications * Prior treatment experimental immunotherapeutics or vaccines for AD * Presence of pacemakers, CSF shunts, or foreign metal objects in the eyes, skin or body
There's nothing else that I could find. There are a couple of trials for LY450139 (that's the gamma secretase inhibitor we've been talking about), but the patients have to be 55 or older.
Then there are a couple on PRX-03140, but for one of those, the patient must be on Aricept but cannot be taking Namenda, and for the other, the patient cannot be taking either one.
Thanks for all this info. Very discouraging though...DH would not qualify for these...Pacemaker less than one year ago, on both Namenda & Aricept...Lake Charles & Shreveport are too far away for us to travel. I was hoping for something in New Orleans. All of his doctors are at Ochsner, a major teaching hospital...and there a couple of other major hospitals. I'll keep checking periodically. Thanks again...
Ochsner does a lot of clinical trials on cancer, but I haven't found any at all on AD.
At least three places in New Orleans have been involved in AD trials, although they're not currently recruiting. I think your best bet is:
Louisiana State University Health Sciences Center, Department of Psychiatry (Geriatric Psychiatry)
Department of Psychiatry LSU School of Medicine 2020 Gravier St. Lions Center, 7th Floor New Orleans, LA 70112 504-568-6004 FAX: 504-568-6006 stefft@lsuhsc.edu
http://www.medschool.lsuhsc.edu/Psychiatry/
Tulane University Health Sciences Center has been involved in one trial, finished last year. Their web sites are practically useless.
Tulane University Health Sciences Center Department of Psychiatry and Neurology 1440 Canal St. New Orleans, LA 70112 504-988-5246
You might try contacting the Tulane Medical Center Neurology Department to find out who does what, their web page was the only one I found that talks about AD, and I only found one doctor who works in the area, Patricia Colon. (What a name for a doctor.)
Tulane Medical Center 1415 Tulane Ave. 4th Floor New Orleans, LA 70112 Phone: 504-988-5561 Fax: 504-988-1781
You have been so incredibly helpful. I am very familiar with these hospitals/clinics. I will look into these. We went to the doctor today and I did ask her about drug trials. She was unaware of any either, but said she would look into it and flag his chart to let us know if she hears of anything. I truly believe that she will. She is so amazing, caring and suportive.
Joan, I looked up the Thibodaux site and immediately knew it wasn't going to be much of a help. It is throughThibodaux General's Rehab Program. The most they are doing right now is a day program and a support group for people with brain injuries (mostly traumatic, not acquired). Through common business connections, I know the people who run both programs. The day program caters mostly to seniors and support group is struggling... one or two members on a good day and they try to meet once per month.
I do have another question/need thoughts/advice...day programs? Most of the programs in my area all appear to cater to seniors (65+). My husband is only 52. We have never discussed a day program and I don't think he needs it yet. I am just trying to think/plan for the future and not wait until the last minute to make major decisions. I fear he will not feel comfortable because of the age difference or will the AD make him not care/realize the difference? He is very socially shy and reclusive, even with our closest friends. I am not even sure he will be able to tolerate spending several hours a day with strangers he doesn't know and who are older than he is.