U of Mass-Lowell is in the final stages of licensing MemoryXL - not a prescription nor FDA approved. Will be on the market soon. New study will be made to determine if it will also delay the onset of AD. Full article at uml.edu
I'm having a wee bit of trouble locating the clinical trials mentioned in the article.
The article says that the formulation will contain folate, vitamin B12 and vitamin E.
There used to be a fairly extensive website for MemoryXL, but nothing is left but the home page. (Very curious.) A cached page says: MemoryXL a combination of vitamins and nutrients that include Folic Acid, Vitamin B12, Vitamin E, S-adenosyl methionine (SAMe), N-acetyl cysteine (NAC), Acetyl-L-carnitine (ALCAR), and Peppermint Oil for a fresh minty taste.
Per clinicaltrial.gov:
The VITAL study (aka the homocysteine study) looked at folate, vitamin B6 and vitamin B12. Principal investigator Paul Aisen, of Georgetown University. This is the only AD study that involved folate or B12.
Vitamin E is under study in several trials, usually in combination with something else (selenium, alpha lipoic acid, or vitamin C)
S-adenosyl methionine has been studied for treating a number of other disorders, but not AD. Ditto acetyl-L-carnitine.
Nothing at all on N-acetyl cysteine
Per the defunct MemoryXL web site, "about 200 people have enrolled in clinical trials." Per the article, the pill has been tested on healthy adults without dementia, adults with early onset Alzheimer's and those in late-stage Alzheimer's (as well as genetically engineered mice.) If the clinical trials were double-blind placebo, the number of AD patients that have been tested is pretty darn small.
Now, I suppose that these could have been privately-funded trials, never registered with the Government web site. But I think I'll wait for the article that's supposed to be published in a couple of months, to get the details, before I get excited.
Oh -- FYI, Dr Shea also recently announced that drinking 2 or 3 glasses of apple juice a day can slow memory loss associated with AD. Based on studies funded by the Processed Apples Institute and U.S. Apple.
Found this as I was trolling the web pages for the site. This info may change or has already been seen but it is news to me:
Alzheimer's Association has agreed to fund the next clinical trials of MemoryXL Based on our laboratory and clinical findings, the Alzheimer's Association has agreed to provide funding for a large, multi-site clinical trial. Our studies thus far demonstrate that we can delay progression of early-stage Alzheimer's disease for at least 2 years, and that we can improve alertness and recall in adults without Alzheimer's disease. Remaining to be determined is whether or not MemoryXL can delay the onset of Alzheimer's disease.
To address this issue, we will provide MemoryXL to a number of individuals with early-stage Alzheimer's disease, and those diagnosed with Mild Cognitive Impairment (MCI). Approximately half of the individuals diagnosed with MCI subsequently "convert" to Alzheimer's disease. If we can delay this conversion, it will indicate that MemoryXL can delay the onset of Alzheimer's disease.
Several local senior centers and AD clinics have expressed interest and will participate in our study. We would welcome more participants. Centers and clinics of any size, and individuals are all welcome. Please contact Dr. Shea directly at 978-934-2881 or by email (thomas_Shea@uml.edu) for more information or an informative presentation (about 45min) for your center/clinic staff. The presentation would be similar to the one posted on this website under "Full Presentation." The inventors of MemoryXL are proud to announce that two of their technical manuscripts have been accepted for publication in the American Journal of Alzheimer's Disease and Other Dementias:
The title of the first accepted paper is:
Efficacy of a vitamin/nutraceutical formulation for early-stage Alzheimer's disease: A one-year open-label pilot study with an 11-month extension
The title of the second accepted paper is:
Efficacy of a Vitamin/Nutriceutical Formulation for moderate to late-stage Alzheimer's disease: A 9 month placebo-controlled pilot study
I have left a message about my husband participating in the trial and also gave a plug for this website. I started my husband on the fish oil and flax seed oil mentioned earlier by a couple in one of the threads. Also, he has been taking B12 shots for 6 months. A new MULTI VITAMIN through a Homeapathic Physician. The vitamins have been for a month. He has remarkable increase in some functions. He makes jokes, smiles, laughs at appropriate times, more verbal. My son in law asked him how he was feelin yesterday. He told him "Great, best I have felt in 2 years". I don't know if this will be gone tomorrow, or whatever, but I am going to continue with present meds and hope things will continue to improve. He still questions me endlessly about leaving him home while I go out, can't draw or write.
I called Dr. Shea this morning, and he returned my call this afternoon. I have tentatively preliminary enrolled him in the study. He said they would furnish the vitamin-therapy at no charge during the testing period. I forgot to ask if he continues taking his present medications but I am assuming he does. He asked about what he was taking now and I told him meds plus the fish oil and flax seed oil, etc. He said "great" and to be sure and continue with the fish oil and for me to take it too.
I told him about Joan and this site. He had not heard of it but was going to look it up. I told him we had been talking about this.
2 Nurse assistants will be calling me in a couple of weeks to fill out a questionaire and they will mail me a packet of information. I am to watch his progress and every couple of months fill out a worksheet explaining how he is doing as far as improvement or no improvement.
I am very excited to try this, particulary after the improvement he is now showing with the fish oil and flax oil.
lmohr, PLEASE ask for a complete list of the ingredients and dosage of each, and then TALK TO YOUR HUSBAND'S DOCTOR before you give anything to him -- or take it yourself.
This guy may be well-meaning, but this is sounding more and more like a snake oil pitch. He has claimed that the pill is perfectly harmless because it contains vitamins and neutraceuticals. That's absurd. These ARE drugs, even though they are not regulated by the FDA. Why on earth else would they have any effect?
For example, you can buy huperzine A over-the-counter, as an "herbal supplement" for improving memory. Nobody should be taking it without talking to a doctor.
This is the drug my husband took in his clinical trial!!!!!
This is the same type of drug as aricept, exelon, and razadyne, and it is a much stronger medicine than they are -- it has much more activity than they do. Your LOs take 10 milligrams of aricept -- that's 25 times as much medicine as my husband takes.
It was bad enough that one of the clinical trials Shea is citing as "proof" that the pill works was "open label", but now you're telling us that the people who determine whether the pill is helping are the caregivers? He isn't screening potential participants against inclusion and exclusion criteria? He isn't confirming your husband's status before the trial starts, using a thorough neuropsych, nursing, and neurology evaluation? He isn't using an NIH-vetted protocol and trained, objective evaluators to determine whether the pill is helping? No one will be monitoring your husband's health, to make sure he doesn't develop an adverse reaction?
No wonder he can conduct a "trial" for so little money!
Sunshyne, you are right on..be leary of a clinical trial without controls. VItamins are drugs and taken incorrectly can kill. For a research study to truly be valid you have to control for variables and need to have criteria to monitor. A placebo will make someone better. The criteria needs to be measurable. We all want our loved ones to do well and that alone makes us poor judges of how it works.
I have been trying to connect with Dr. Shea, but we are currently playing phone tag...
Here is a "draft" FAQ that I found at the site: ( I say draft as this site is still changing every time I check)
Is there any other non-prescription formulation that has been clinically proven to mitigate Alzheimer's Disease symptoms?
MemoryXL is the only formulation that has been clinically proven to mitigate Alzheimer's Disease symptoms.
Do I need a doctor’s prescription?
MemoryXL is a non-prescription formulation of vitamins and nutrients.
What are the ingredients?
MemoryXL a combination of vitamins and nutrients that include Folic Acid, Vitamin B12, Vitamin E, S-adenosyl methionine (SAMe), N-acetyl cysteine (NAC), Acetyl-L-carnitine (ALCAR), and Peppermint Oil for a fresh minty taste.
These ingredients and their particular formulation were developed from over 10 years of study by Dr. Shea and his research team.
Can I take MemoryXL if I am already taking a prescribed Alzheimer's Disease medication?
MemoryXL is not designed to replace any prescribed medication or treatment, and can be taken with other Alzheimer's Disease medication. Send any questions to our medical advisor (via our Contact Us page), or ask your Doctor to contact us.
What are the advantages of taking MemoryXL as opposed to prescribed medications?
No side effects have been reported in our Clinical Trials. Compare that to the side effects and cost of these prescription medications for Alzheimer's Disease. You can also start MemoryXL before an official diagnosis is made. Unlike Alzheimer drugs, you can start MemoryXL at the first sign of memory loss, or better yet, BEFORE any memory problems.
How long have people been taking MemoryXL?
People have been taking MemoryXL as long as 2 and 1/2 years with continued beneficial effects. Maximal improvement in memory and in mood was seen after 3-6 months, which was then sustained for as long as two years so far.
How many people have been enrolled in clinical trials?
About 200 people have enrolled in clinical trials.
What does the medical community (Doctors) think of MemoryXL?
Dr. Shea says, "While important advances in drug treatments have been, and continue to be made, there is a consensus among in the medical community, echoed at every meeting of the Alzheimer’s Association, that we have long needed an early treatment, one that can be administered at the first suggestion of memory loss, or even before it. MemoryXL is the only clinically-proven product to fill this need; it can be taken without prescription, at or before the first signs of memory loss, yet is still effective throughout the entire course of Alzheimer’s disease."
How long will it take me (a healthy person) to see any improvement?
People taking memoryXL have seen improvement in as little as two weeks in Clinical Trials.
How long will it take the patient ( a person with Alzheimer's Disease or Mild Cognitive Impairment) to see any improvement?
Patients with Alzheimer's Disease or Mild Cognitive Impairment have seen steady improvement in Activities of Daily Living, Neuropsychiatric Inventory, and Dementia Scale Rating in clinical trials.
Are there any side effects?
MemoryXL is non-prescription formulation of vitamins and nutrients. No side effects have been noted during the clinical trials.
I am going to ask my FP about me also taking the MemorX Trial. I currently take Folic Acid, Fish Oil, MV, Calcium. I do not have demetia (I don't think) although frequently I am not so sure.
I reiterate: I have NOT been able to find ANY evidence of clinical trials conducted with this formulation. I suspect, from the careful wording elsewhere at this on-again/off-again site, that they are cobbling together results from OTHER clinical trials that tested SOME of the components of this mixture. Which is not valid... not in the least.
I will wait to develop my final conclusions until they publish. In theory, they have a couple of papers accepted for publication, which should be out soon.
I have been trying to get in touch with Dr. Shea. So far, we are playing phone tag. I can ask him these questions when I do speak with him and will let you all know.
Here is a form email I received today from Dr. Shea. I sent back I was interested in participation. I will discuss it with his Dr. as soon as I receive more information about the product.
Good afternoon,
This email regarding our Alzheimer formulation is being sent in bulk to many families and individuals. I’m sorry to take so long to get back to some of you; we have had over 100 phone calls and many many emails since our recent press releases.
Our vitamin/nutriceutical formulation is going to made available in two ways: the first and most likely important method to most of you is made possible by a generous grant from the Alzheimer’s Association. We are in the process of starting another round of our clinical studies. We have very strong, published scientific evidence that our formulation is capable of maintaining, and in many cases improving, cognition/memory, as well as alleviating some of the depression, agitation, and other behavioral difficulties that accompany Alzheimer’s disease. We now want to learn more about how it can help very early memory loss, even before an official diagnosis of Alzheimers, and we also want to learn if it is even more effective in combination with any prescribed drugs. We will accept participants at any stage of Alzheimer’s disease, and with any doctor’s serious concern regarding memory loss.
You will receive the formulation for free for at least one year. One of my associates (Ruth Remington or Jill Zemianek) will arrange to meet with the participating individual and a designated caregiver (family member who knows the participant best, OR if participant is in a nursing home, a staff member can serve in this capacity). The participant completes two standard clinical evaluation tests (these are used routinely for Alzheimer’s), and the caregiver completes two standard evaluation forms regarding how the participant is doing on a day-to-day basis. We do this at the beginning of the trial, 1-2 months later, then a total of every 3 months for a year. Ruth or Jill will arrange to meet you at a convenient time at your home/nursing home, or, if you prefer, the library of your town, or, you can come to us at Lowell. Each visit should be approx 1hr total. There is no charge of any kind, no need to change diet or medications, and you can of course discontinue at any time. Your name is confidential and you do not end up on any mailing or phone list for the Alzheimer’s Association (someone asked me that!). They will bring more information with them for you in the first visit.
You MUST consult with your family doctor, or neurologist if you have one, regarding this formulation and participating. Have he or she contact me for any information requested. This formulation has shown no serious adverse events, and is compatible with Alzheimer drugs, but it is not right to “go around” your doctor’s approval. Also, do NOT consider stopping any prescribed medication in favor of our formulation.
If you are interested in this clinical study, please contact me via phone or email.
For those of you who are concerned about aging, memory, family history of Alzheimers, or just good brain health, we are sorry, but we cannot enroll you in the study: the above grant is for Alzheimer’s/ serious memory loss only. However, the formulation will be available for purchase soon as “MemoryXL.” UMass is in the final stages of licensing our formulation to a boston-based company called “MemoryXL.” I will serve as the Chairman of the Science Advisory Board of this company. The company web site is www.memxl.com and its tollfree number is 800-376-5566. This site is NOT fully operational yet, but will be soon: keep checking it or check back with me. This is the identical formulation utilized in all of our prior studies, some of which you may have heard of under the name “SmartPill”. We abandoned that name (never meant for it to be public!) since it is already licensed and this formulation doesn’t make you smarter, it helps your memory! And it is the identical formulation in use in the new clinical studies above.
Again, I apologize for taking so long to get back to all of you. Let me know if you want to be part of our study!
This stuff has never been in a real trial, as far as I can see. Did you look at the papers he sent you, Guy?
The first "trial" was open label and had no placebo group, if I recall correctly. So we were waiting for these publications to see if this formulation has ever been in a double-blind, placebo-controlled trial.
When you wade through the details, the "trial" had 10 patients TOTAL, half placebo and half treatment. By six months, 5 subjects had withdrawn, leaving no one in the placebo group. By 9 months, the remaining 5 subjects were gone. for one reason or another, and the study was halted. So they've actually got one data point, at 3 months, with 5 patients per group.
It's really very hard to draw valid conclusions under these circumstances. Plus, I'm no statistician, but it appears to me that the statistical analyses of the data are invalid -- the method they used is unusual, and the standard deviations at each data point are HUGE.
Not to mention the tests that were used to evaluate the patients' cognitive function are not very common, and relied heavily on caregiver ratings.
Furthermore, this is the only study that they've done on patients in the moderate to severe stages of AD. So they have nothing that, to my mind, indicates any efficacy for these stages.
I mentioned way back when that I suspected that what he was referring to as "clinical evidence" must either be trials conducted with just one of the ingredients (and done in combination with other things), or was pre-clinical. And that turns out to be true -- almost every paper he's cited are studies done with rats, genetically altered mice, or cell cultures (mostly rodent, one human neuroblastoma).
Y'all know my opinion of relying on studies done with genetically engineered mice...
Then I started looking at the individual constituents, and blew a gasket. Yes, Vitamin E has been studied in clinical trials ... at levels far, far higher than what he has in his formulation. His formulation doesn't even have nearly as much Vitamin E as I take, just for general health. You'd get a lot more just in your diet. His pill wouldn't cause a ripple.
That was where I stopped doing an evaluation. There's just no solid evidence at ALL for this formulation. And I really don't care for scientists who misrepresent what has been done (or seem to be unaware of what's been done!)
Now. Please think about this: If you have any desire whatsoever to include your spouse in a clinical trial of something like bapineuzumab, or a RAGE inhibitor, Dimebon (they're going to launch a new trial soon), a gamma secretase inhibitor, etc, if you participate in this "trial", it could easily disqualify you from being in any of the others.
Yes I did, that's why I don't get it. It seemed to me there were trials coming up, and that in his email he said that if we wanted to use this, we would need to speak to our doctor and then get back to him. He would then send people out to meet with us to see how they were doing.
And yes I agree, the 'trials' do not seem conclusive at all, and again, I am not quite sure why now, it is available.
On his site they mention he is going to get some funding (approx. 240K) from the Alzheimer's Org, but I would have thought that still, he would need to really keep at this before it was "on sale."
I do not pretend to understand all of this, but I was having mixed feelings about it. Yes I want something to be out there that works, but all we get is misleading info and hyped up news stories. If we didn't have you around to smack us and tell us to wake up, I'm sure there would be many rich snake oil sales people out there!
I'm disappointed in all of this and I know that the 'desperation impulse' is pulling at me.
To top that off, my wife fell this morning while feeding the cats and was very dizzy. I had to walk her back to the bed, but only got as far as the couch. She's in bed now, but what a scare. I'm thinking TIA, dehydration... the terror I feel some days could power a rocket ship to the Andromeda Galaxy!
Hi I'm Tom Shea, head of the UMass team that developed the above formulation. I hope to clear misconceptions, and to make myself available for any questions.
I applaud your skepticism. We are a team of academic researchers, and none of us are going to become wealthy people even if everyone starting using this formulation. I've worked on AD since the '80's, lost one family member to it, and will soon lose another. We worked for some 10 years on nutritional supplements in cell cultures then mice, and came up with 6 that worked well together. We then started at the UMass Memorial clinic. One small group of early-stage participants living at home took the formulation for a year, showed statistical improvement within 3 months,maintained it for 12. Families asked if they could stay on: they maintained improvement >2 years so far. The group is small (the paper says "pilot study"). Our 2nd study was with late-stage institutionalized individuals. No improvement, but delay of decline. I will email these to anyone. This isnt a cure,nor replacement for a drug. Its not the best thing that will ever appear. The Alz Assoc funded further study for 300 people. We're delayed since we are shifting the study to McLean Hospital (i was there for 10 years), will include Oklahoma AD Center, and possibly Univ Maryland. I havent forgotten people with whom I have talked. The WBZ radio spot came out when our new funding was awarded, way before we were ready to start. Trials have been small, but we had no $: UMass paid for the formulation, every team member worked for 3 years for free. New funding will allow us to gain more data, esp how the it might work in comb. with aricept or namenda. We couldnt achieve statistical improvement with a small group unless the effects were real. I'm now writing up data that shows >90 adults without dementia improved in cognitive performance within 3 months, placebo-controlled, and blind. It will be a while before publication, but I'll email the data to anyone.
To address some of concerns: We don't carry out diagnosis, we rely on the family's physician(s) and/or neurologisit for that AND for approval to enter the study. No one has been, nor will be, allowed in without both, which has or will be determined in the first interview.
Someone was concerned that we have data from caregivers: we used 2 cognitive tests for the individual with AD (Dementia Rating Scale, Clock-Drawing test), and 2 caregiver reports (Neuropsychiatric Inventory, Activities of Daily Living). Perhaps its not clear, but the last two must be completed by caregivers. Once an individual is institutionalized, then a staff member is used. My mother, 82 and demented, is in a nursing home, I am no longer the right person to ask about her day-to-day behavior, her staff caregiver is a better judge.
The formulation contents: folic acid 400mcg, B12 6mcg, vitE 30 I.U., S-adenosyl methionine 400mg, N-acetyl cysteine 600mg, acetyl-L-carnitine 500mg. These are all over-the-counter,not drugs. You can buy all of these at Walgreen's, CVS, etc. The first 3 are in a multi-vitamin; we kept their concentrations low is (1) they didnt need to be higher when combined with the others and (2) we didnt want to exceed recommended daily allowances for those people who might take a multi-vitamin. I've been saying this for the past 5 years at every Map Through the Maze conference (AlzAssoc) and anywhere else I've spoken. For those of you that are taking larger doses of any vitamins or supplements, or providing them to a family member with Alzheimer's disease, always consult your physician. There are many other promising supplements that I haven't studied. Discuss them all with your physician.
UMass owns and has licensed the formulation. Several of you saw draft versions of the memoryXL website, posted for "live" editing long before it was available. I'm on the science advisory board of that company, not an employee. This means i don't get rich, but get to watch over things. Note that this is separate from the Alzheimer's funded clinical study... anyone enrolled in that study receives it for free for a year.
I'm very saddened by this because I spent a large part of my life trying to make a difference for AD, and will continue to do so. I never thought I would see the day when a reference to snake oil salesmen would include me. If i didn't have confidence in the formulation i certainly wouldn't do more clinical work. Just because I'm a scientist doesn't mean i have no fear of God.
I will present at the Alz Assoc "Map through the Maze". Please, email me for comments or discussion: Thomas_Shea@uml.edu. I would meet with any group about our studies and plans, anywhere, any time, as I have for years, no reimbursement. Whatever you do in this fight against Alzheimer's, keep nutrition strong as a base.
I am Joan, the owner of this website, and I want to thank you for enlightening us. It was extremely helpful and informative.
Up until 2 years ago, I lived in Massachusetts, and just as an interesting tidbit of information, I worked at U Mass. Medical school in 1970, when the first group of medical students were accepted. I believe there were 16 of them.
I sent for Memory XL one month ago for my husband. He has been taking Aricept since July of 2008 for Alzheimers. I gave him two pills at 10am and by 6pm that evening we could see a wonderful difference in his memory and personality. They said it would work in a different way for each person and we are happy to report he was very lucky to have a fast response. It may work for only a year or two, but we will enjoy every minute.
I am so confused by all this info. Was there an actual trial ever completed? Why did Alz give them money? Was it for research or to fund the release of their product? Utah Grannie, How long has dh been on Memory XL? Has it truly made a difference? Do you mind if I ask what other meds he is taking? We are all looking for a miracle but I for one want a safe miracle-even if it's a mini miracle. Has anyone else tried this? Any other info avail? What is the website for other info? I haven't looked at the alz website but have they mentioned this? God, please let this be a help!!!
In 2005 my husband was told he had a vitamin B-12 deficiency and it was causing memory loss and some confusion. We gave him him B-12 shots until 2008 with no improvment. A new doctor told us he was in the middle stages of Alzheimers and put him on 5mg of Aricept until December of 2008, then moved him to 10 mg of Aricept, which he could not tolorate. He experienced dizziness, headaches and confusion. We also tried samples of Namenda with the same results. My husband refused to take anymore medication except 5mg of Aricept. Last month while attending an Alzheimers Assoc meeting we were told about Memory XL and the good results they were having in the trials. As I stated in earlier comments - 5 days ago I gave him two pills at 10am and by 6 pm we could see wonderful results with his memory and personality. I honestly think he is back to alzheimers stage three. He is willing to take the pills now because they were vitamins etc and he felt no side effects. Thank you Tom Shea and your team I can verify they work I found them on "Google" then Memory Xl.
I would like to give you an up-date on memoryXL My husband had an appt. with his neurologist Dr Navin Varma yesterday and we took all the information available on memory XL to our visit. After reading everything he stated he could see no harm in taking the supplement if we felt it was helping with his alzheimer's disease. I had one problem with my husband after taking the supplement for about two weeks. He is feeling so much better and more alert that he want's to drive the car once again. Dr Varma told him that was not possible. He reluctantly agreed to that decision. I relaize this is not a cure for alzheimer's disease, but it makes life so much easier for my husband and also myself. His personality has changed back to the way he was a few years ago. He is happy, and fun to be around. Our family and grandchildren stated "we have grandpa back once again".