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Nominal Benefits Seen in Drugs for Alzheimer's
NY TIMES ^ | April 7, 2004 | DENISE GRADY

Posted on 04/07/2004 10:08:36 PM PDT by neverdem

The drugs now available to treat the memory and thinking problems of Alzheimer's disease have not lived up to the public's high expectations for them and offer such modest benefits on average that many doctors are unsure about whether to prescribe them.

Although the drugs have their advocates, grateful for any sign of improvement, others express disappointment in light of earlier hopes that the drugs approved in the last decade would stop the disease or markedly slow it.

At a meeting in late March at Johns Hopkins University, doctors and other health professionals heard Alzheimer's researchers debate the usefulness of the drugs and the prospects of better treatments becoming available any time soon. Some researchers say it may be decades before real progress is made in reducing the toll of the disease.

When a frustrated doctor in the audience accused a panel of experts of evading the question of whether the drugs should be prescribed, the auditorium burst into applause.

One expert replied that there was just one chance in 10 that the drugs would have an effect and that patients should try them for six to eight weeks and then quit if there was no improvement. A second expert gave the drugs somewhat better odds of helping. A third said to try the drugs for six months. A fourth said, "The kind of evidence you want may not be available."

The moderator summed up, saying: "For us to tell you what to do, I think would be wrong. All you can do is look at your soul and do the best you can."

About 4.5 million Americans suffer from Alzheimer's disease, and many patients and their families see the five drugs now available to treat it as their only defense against its relentless destruction of the mind. Patients usually take one drug. Each costs about $120 a month. They are meant to aid thinking and memory, though they do not change the underlying course of the illness. A million Americans take them, at an overall cost of $1.2 billion a year.

"We don't want to raise expectations that the effects of these drugs are large," said Dr. Peter Whitehouse, a professor of neurology and bioethics at Case Western Reserve University.

And yet the medicines are all that doctors have to offer. Though researchers are trying to develop new treatments, no breakthrough is near, said Dr. Constantine G. Lyketsos, director of the Alzheimer's center at Johns Hopkins.

"The public thinks a cure is around the corner," Dr. Lyketsos said. But he said he did not expect any "realistic reduction in the huge number of cases for decades."

Clearly, the drugs can alter brain chemistry, and some studies show statistically significant improvements on tests that measure thinking and memory. But while a few extra points on a mental exam, or other changes obvious to a specialist, may be enough to get a drug approved by the Food and Drug Administration, they may not be enough to help a person with Alzheimer's dementia function in the real world.

"You can name 11 fruits in a minute instead of 10," said Dr. Thomas Finucane, a professor at Johns Hopkins and a geriatrician. "Is that worth 120 bucks a month?"

Dr. Finucane, the conference speaker who advocated a six-to-eight-week trial of the drugs, said that most of his patients tried Aricept, the leading drug, but that only 10 percent of them found it worth continuing.

"There is very limited efficacy in making the patient's life or the caregiver's life better," he said, noting that a professional group, the Academy of Neurology, had stopped short of recommending the drugs but had instead urged doctors to "consider" using them.

Four drugs — Aricept, Exelon, Reminyl and Tacrine — are approved to treat the symptoms of mild to moderate Alzheimer's. All raise levels of acetylcholine, a chemical that transmits nerve signals in the brain. A fifth drug, Namenda, which works on a different neurotransmitter, was approved last year for moderate to severe cases.

"In my opinion, in 10 years we'll be embarrassed by how much of this stuff we prescribed," Dr. Finucane said, adding that he thought hundreds of millions of dollars were being wasted on the drugs. But he also said he understood why patients and families wanted them.

"Alzheimer's disease is a slow-motion disaster," he said. "It's very hard to sit by and watch. There is an overwhelming desire to do something, even if it's to give a useless pill every day."

Dr. Steven T. DeKosky, chairman of neurology and director of an Alzheimer's research center at the University of Pittsburgh, said he took a very different approach, prescribing drugs for all his Alzheimer's patients unless they cannot tolerate them. He said that it took at least six months to tell whether the drugs were helping.

Dr. DeKosky said the "data are overwhelming" that the drugs help patients stay functional a bit longer. In addition, he said, family members often tell him that patients improve with the medicines, or at least seem to decline less steeply. From 7 to 10 percent, he said, have a noticeable, if temporary, improvement, which researchers call a "Lazarus effect."

"They are symptomatic, mildly effective medications," Dr. DeKosky said. "They are not the silver bullets to stop the disease or slow it down. They don't restore anybody's memory to what it was in the past."

The drugs can buy patients some time, blunting the deterioration for up to a year, Dr. DeKosky said.

"At this point, small victories are what we have to settle for," he said.

Researchers acknowledge that opinions diverge widely on the treatments. Dr. Jason Karlawish, a geriatrician at the University of Pennsylvania's Institute on Aging, said, "There is substantial controversy over the claim that current F.D.A.-approved treatments improve function or slow a patient's decline."

He blamed several factors for the controversy, including "the lack of widely understood and accepted measures to show improvement or slowing of decline, small effects on the few measures some experts agree are appropriate, and controversial and even outrageous approaches to analyzing the data to make the claim the drug slows a patient's decline."

Dr. Karlawish, Dr. Finucane and other researchers said they were particularly irked by a study published last July in The Journal of the American Geriatrics Society, claiming that Aricept could delay a patient's need for nursing-home care by nearly two years — something that would clearly matter to patients and families.

Pfizer, which makes Aricept, paid for the study and its scientists were among the article's authors. The critics said the study was flawed, and its data did not support the claim.

Letters criticizing the study, and the authors' rebuttal, are to be published in the May and June issues of the geriatrics journal.

The editor of the journal, Dr. Thomas Yoshikawa, declined by e-mail to discuss the details of the study but said that it had passed muster with journal editors and several outside experts. But he also noted that expert opinion was divided as to whether the drugs improve quality of life for patients or those caring for them.

An author of the study, Dr. David S. Geldmacher, a neurology professor at the University of Virginia, said, "I believe the data we report are accurate and the conclusions are appropriate."

In interviews, Alzheimer's patients and their relatives said they were pleased to have the drugs, and most thought they helped.

Cathleen McBride, 64, a retired guidance counselor and English teacher in Bridgewater, Mass., whose case of Alzheimer's was diagnosed two and half years ago, said she had been taking Aricept for almost two years.

"I'm holding my own," she said. She can no longer cook or drive, but she continues to read, do crossword puzzles and give public talks about Alzheimer's disease.

Asked if the drug made a difference, she said: "I can't say. It's hard to observe oneself in a situation like this."

Her husband, Owen, said, "There's no way to check it unless you stop and see if you fall through the floor."

Isabel Shipmon, a real estate agent in Middletown, N.Y., said that her mother, Luisa Cancel, took Aricept off and on for a few months at a time, for a total of about a year.

"It kept everything balanced for a minute," Ms. Shipmon said. "She seemed like she was a little bit more alert, held her thoughts a little longer, like it didn't progress. You have her for a second, and that's it."

Gradually the drug seemed to stop working, Ms. Shipmon said. Her mother is now in a nursing home.

Marie Heuer, a retired secretary in St. Louis, has been taking Aricept since learning she had Alzheimer's disease about four years ago at age 55.

The drug had an immediate effect, she said: "It was like a cloud being lifted. I'm very grateful we've gotten it."

Martha Daly, who lives with Ms. Heuer, said: "The progression slowed immediately. It was obvious to her friends and certainly to her family."

Once a patient starts taking a drug, even if there is no obvious improvement, many doctors and family members hesitate to stop, because they figure the drug is doing no harm and think it may at least be stopping the patient from getting worse. And they fear that quitting may lead to a sharp decline.

Emerson Moran, a writer in Palm Beach Gardens, Fla., said his wife, Pat, 64, had been taking Aricept for about five years. He said it seemed to make her more alert and may have helped her regain a bit of her ability to read, but that the effects lasted no more than a year, which was about what doctors told the couple they might expect.

He is still giving his wife the pills. "Why not?" he said. "Our physicians throughout have just recommended keeping her on it. My guess is that they don't know anything more than we do."

TOPICS: Business/Economy; Culture/Society; Extended News; Government; News/Current Events; US: District of Columbia
KEYWORDS: acetylcholine; aluminum; alzheimersdisease; aricept; exelon; fda; namenda; pfizer; reminyl; tacrine

1 posted on 04/07/2004 10:08:37 PM PDT by neverdem
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To: fourdeuce82d; Travis McGee; El Gato; JudyB1938; Ernest_at_the_Beach; Robert A. Cook, PE; lepton; ...
2 posted on 04/07/2004 10:10:12 PM PDT by neverdem (Xin loi min oi)
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To: All

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3 posted on 04/07/2004 10:12:11 PM PDT by Support Free Republic (Hi Mom! Hi Dad!)
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To: neverdem

I think my mother would fiercely prefer to graduate from this life sooner rather than hang on in her very marginalized state for a prolonged time.
4 posted on 04/07/2004 10:19:15 PM PDT by Quix (Choose this day whom U will serve: Shrillery & demonic goons or The King of Kings and Lord of Lords)
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To: Quix; neverdem
Did anyone notice on Fox News a few weeks ago a report that nicotine seems to deter alzheimers and parkinsons? I don't recall what stage of research this was at.
5 posted on 04/07/2004 10:31:44 PM PDT by AuntB ("What if they find life on Mars and it's just more pissed off Muslims?"........Dennis Miller)
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To: neverdem
I have an aunt with Alzheimer's. She is not doing real well. But then she has other health issues as well.
6 posted on 04/07/2004 10:38:14 PM PDT by farmfriend ( Isaiah 55:10,11)
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To: farmfriend
It is a horrible, cruel disease. It is watching someone slip away bit by bit, punctuated by an occasional crisis in which the person makes a sudden turn for the worse, then things level off but get slowly worse, followed by another crisis, and this goes on for years... It is cruel to the patient and cruel to the patient's family.

Having seen what it does to a person, it has made me bitter about life in general. Anyone can work hard his whole life and finally, when, according to the American Dream, life should become easier, one can be deprived of enjoying life because of this disease. That article brought back some unpleasant memories. Some things stay with you -- it has been years but I still often jump whenever the phone rings (being conditioned to have to rush to the hospital, or...).

7 posted on 04/07/2004 11:15:16 PM PDT by Wilhelm Tell (Lurking since 1997!)
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To: AuntB

It's on my HD somewhere!

Mother really is past the stage when she'd prefer to still be in this life.

On the other hand, she has virtually never had the graciousness to go anywhere very . . . serenely.

She fusses about wanting Jesus to come and get her. Yet, has trouble letting go. And that's when she's mostly in whatever degree of awareness she has left.

It's real tricky trying to figure out how to get her to let go. Has never been a great facility of hers.
8 posted on 04/07/2004 11:40:14 PM PDT by Quix (Choose this day whom U will serve: Shrillery & demonic goons or The King of Kings and Lord of Lords)
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To: AuntB
Did anyone notice on Fox News a few weeks ago a report that nicotine seems to deter alzheimers and parkinsons? I don't recall what stage of research this was at.

I don't recall either. Maybe I'm losing my short term memory. You're welcome to explore these links. Don't click on the authors' names. Click on the "related articles". You'll get the same titles and authors with abstracts when available. BTW, I went to the website "PubMed" and entered "nicotine AND (alzheimer's OR parkinson's)" for the search, IIRC.

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Items 1-20 of 383
 of 20
1: Newhouse PA, Potter A, Singh A. Related Articles,
Abstract Effects of nicotinic stimulation on cognitive performance.
Curr Opin Pharmacol. 2004 Feb;4(1):36-46.
PMID: 15018837 [PubMed - in process]
2: Salin-Pascual RJ, Alcocer-Castillejos NV, Alejo-Galarza G. Related Articles,
Abstract Nicotine dependence and psychiatric disorders.
Rev Invest Clin. 2003 Nov-Dec;55(6):677-93.
PMID: 15011738 [PubMed - in process]
3: Hellstrom-Lindahl E, Mousavi M, Ravid R, Nordberg A. Related Articles,
Abstract Reduced levels of Abeta 40 and Abeta 42 in brains of smoking controls and Alzheimer's patients.
Neurobiol Dis. 2004 Mar;15(2):351-60.
PMID: 15006705 [PubMed - in process]
4: Myers CS, Robles O, Kakoyannis AN, Sherr JD, Avila MT, Blaxton TA, Thaker GK. Related Articles,
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Psychopharmacology (Berl). 2004 Mar 2 [Epub ahead of print]
PMID: 14997272 [PubMed - as supplied by publisher]
5: Sharp B, Yatsula M, Fu Y. Related Articles,
Abstract Effects of galantamine, a nicotinic allosteric potentiating ligand, on nicotine-induced catecholamine release in hippocampus and nucleus accumbens of rats.
J Pharmacol Exp Ther. 2004 Feb 9 [Epub ahead of print]
PMID: 14769831 [PubMed - as supplied by publisher]
6: Liu Q, Zhao B. Related Articles,
Abstract Nicotine attenuates beta-amyloid peptide-induced neurotoxicity, free radical and calcium accumulation in hippocampal neuronal cultures.
Br J Pharmacol. 2004 Feb;141(4):746-54. Epub 2004 Feb 02.
PMID: 14757701 [PubMed - in process]
7: Nordberg A. Related Articles,
Abstract Toward an early diagnosis and treatment of Alzheimer's disease.
Int Psychogeriatr. 2003 Sep;15(3):223-37.
PMID: 14756159 [PubMed - in process]
8: Newhouse P, Singh A, Potter A. Related Articles,
Abstract Nicotine and nicotinic receptor involvement in neuropsychiatric disorders.
Curr Top Med Chem. 2004;4(3):267-82. Review.
PMID: 14754447 [PubMed - indexed for MEDLINE]
9: Di Angelantonio S, Bernardi G, Mercuri NB. Related Articles,
Abstract Donepezil modulates nicotinic receptors of substantia nigra dopaminergic neurones.
Br J Pharmacol. 2004 Feb;141(4):644-52. Epub 2004 Jan 26.
PMID: 14744806 [PubMed - in process]
10: Moore SA, Huckerby TN, Gibson GL, Fullwood NJ, Turnbull S, Tabner BJ, El-Agnaf OM, Allsop D. Related Articles,
Abstract Both the D-(+) and L-(-) enantiomers of nicotine inhibit Abeta aggregation and cytotoxicity.
Biochemistry. 2004 Jan 27;43(3):819-26.
PMID: 14730987 [PubMed - in process]
11: Kostrzewa RM, Segura-Aguilar J. Related Articles,
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PMID: 14715440 [PubMed - indexed for MEDLINE]
12: Lemay S, Chouinard S, Blanchet P, Masson H, Soland V, Beuter A, Bedard MA. Related Articles,
Abstract Lack of efficacy of a nicotine transdermal treatment on motor and cognitive deficits in Parkinson's disease.
Prog Neuropsychopharmacol Biol Psychiatry. 2004 Jan;28(1):31-9.
PMID: 14687854 [PubMed - indexed for MEDLINE]
13: Arias E, Ales E, Gabilan NH, Cano-Abad MF, Villarroya M, Garcia AG, Lopez MG. Related Articles,
Abstract Galantamine prevents apoptosis induced by beta-amyloid and thapsigargin: involvement of nicotinic acetylcholine receptors.
Neuropharmacology. 2004 Jan;46(1):103-14.
PMID: 14654102 [PubMed - indexed for MEDLINE]
14: Hayslett RL, Tizabi Y. Related Articles,
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15: Mousavi M, Hellstrom-Lindahl E, Guan ZZ, Shan KR, Ravid R, Nordberg A. Related Articles,
Abstract Protein and mRNA levels of nicotinic receptors in brain of tobacco using controls and patients with Alzheimer's disease.
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PMID: 14614915 [PubMed - indexed for MEDLINE]
16: Tan EK, Tan C, Fook-Chong SM, Lum SY, Chai A, Chung H, Shen H, Zhao Y, Teoh ML, Yih Y, Pavanni R, Chandran VR, Wong MC. Related Articles,
Abstract Dose-dependent protective effect of coffee, tea, and smoking in Parkinson's disease: a study in ethnic Chinese.
J Neurol Sci. 2003 Dec 15;216(1):163-7.
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17: Hook VY, Reisine TD. Related Articles,
Abstract Cysteine proteases are the major beta-secretase in the regulated secretory pathway that provides most of the beta-amyloid in Alzheimer's disease: role of BACE 1 in the constitutive secretory pathway.
J Neurosci Res. 2003 Nov 1;74(3):393-405.
PMID: 14598316 [PubMed - indexed for MEDLINE]
18: White HK, Levin ED. Related Articles,
Abstract Chronic transdermal nicotine patch treatment effects on cognitive performance in age-associated memory impairment.
Psychopharmacology (Berl). 2004 Feb;171(4):465-71. Epub 2003 Oct 08.
PMID: 14534771 [PubMed - in process]
19: Lemay S, Blanchet P, Chouinard S, Masson H, Soland V, Bedard MA. Related Articles,
Abstract Poor tolerability of a transdermal nicotine treatment in Parkinson's disease.
Clin Neuropharmacol. 2003 Sep-Oct;26(5):227-9.
PMID: 14520160 [PubMed - indexed for MEDLINE]
20: Doggrell SA, Evans S. Related Articles,
Abstract Treatment of dementia with neurotransmission modulation.
Expert Opin Investig Drugs. 2003 Oct;12(10):1633-54. Review.
PMID: 14519085 [PubMed - indexed for MEDLINE]
Items 1-20 of 383
 of 20

9 posted on 04/08/2004 12:23:06 AM PDT by neverdem (Xin loi min oi)
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To: Quix
You are up against one of the greatest battles of all to help a very much loved one leave this world naturally and without guilt or remorse....

I know one nurse who would tell very sickly elderly patients that they "could go now" them a permission so to speak , to slip out of this world peacefully.....

The time will come......just hang in there and make it go as Godly as it can.....

10 posted on 04/08/2004 12:31:00 AM PDT by cherry
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To: cherry
OH, I agree. A mutual friend assisted her with her own mother who lay in the hospital for most of a year more or less comotose. Our friend instructed grandma by speaking to her spirit that it was time to go home now; to let go and go home. She died within 3 or so days later.

Alas, mother is more the type to keep a fearful death grip on the status quo whether it makes sense or not. Were she in her right mind looking at someone in her state--she'd be fiercely adament that graduating from this life would be greatly better.

I think at this point, prayer is the biggest key thing.

11 posted on 04/08/2004 12:47:10 AM PDT by Quix (Choose this day whom U will serve: Shrillery & demonic goons or The King of Kings and Lord of Lords)
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To: neverdem
I am a fulltime caregiver. 11 1/2 years now. Mom is total toast.

I'm on 60ng of prozac daily. Works better than giving Aricept or Exelon to mom. She's on mega doses of exelon now, but no benefit at all.

I've searched from John Hopkins to local neurologists for something that will help. Total waste of time and money. They've got nothing, nada, zip, zilch to help an alzheimers patient in the late stages.
12 posted on 04/08/2004 4:12:01 AM PDT by JoeSixPack1 (Kerry is a combat vet. But he fought for the wrong side.)
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To: JoeSixPack1
I am a fulltime caregiver. 11 1/2 years now.

Wow. That must be rough. I hope you have someone to share the burden. What often happens is that one or two family members will do most of the work and everyone else will distance themselves. I know one woman who is taking care of her terminally ill mother. Her siblings have distanced themselves -- the are very rude whenever she asks for anything, which is seldom. What is ironic is that she is the least liked child in this dysfunctional family and yet she is doing all the work. The "good" children who were favored feel like they are entitled to not help at all. People can be cruel.

13 posted on 04/08/2004 5:22:53 AM PDT by Wilhelm Tell (Lurking since 1997!)
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To: Wilhelm Tell
You nailed it 100%.

My older brother, the golden boy when we were kids back home, told me in no uncertain terms, in fact, let me quote what he said when just 2 months ago I finally succumbed to the pressure and asked for some help "NO HOW, NO WAY, NO F'''ING WAY".

14 posted on 04/08/2004 6:59:04 AM PDT by JoeSixPack1 (Kerry is a combat vet. But he fought for the wrong side.)
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To: JoeSixPack1
"I'm on 60ng of prozac daily"

No one understands what the caregiver goes through until they have to do it. I spent 7 of the last 8 years "providing" for a brain tumor patient...not Alzhiemers, but much the same. As if the patient isn't enough there is that never ending search for treatment that you mentioned. I'm not sure I'll ever recover.

15 posted on 04/08/2004 10:57:36 AM PDT by AuntB ("What if they find life on Mars and it's just more pissed off Muslims?"........Dennis Miller)
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