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Joel S. Ross, MD |
MD FACP AGSF CMD CPI |
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« Even minor memory lapses could be significant!!! | Home | Dimebon a failure in the treatment of Alzheimer’s Disease patients »
Real World Study of FDA approved Alzheimer’s Disease Drugs: Pause for ?Concern
By Joel Ross | February 4, 2010
In the many years I have been working with pharmaceutical testing of new AD compounds, the real world benefit of the below mentioned drugs has always been a very important question. Perhaps now my readers will see a different slant of the benfits/risks of such meds. I report the below article for my readers to simply understand the differences between clinical research setting/testing of AD drugs vs. the “real world” testing of AD drugs outside of the pharmaceutical sponsored study. These drugs do work for some and not for others.
Effects of Donepezil, Galantamine and Rivastigmine in 938 Italian Patients with Alzheimer’s Disease: A Prospective, Observational Study
Santoro, Aurelia; Siviero, Paola; Minicuci, Nadia; Bellavista, Elena; Mishto, Michele; Olivieri, Fabiola; Marchegiani, Francesca; Chiamenti, Andrea Maria; Benussi, Luisa; Ghidoni, Roberta; Nacmias, Benedetta; Bagnoli, Silvia; Ginestroni, Andrea; Scarpino, Osvaldo; Feraco, Emidio; Gianni, Walter; Cruciani, Guido; Paganelli, Roberto; Iorio, Angelo Di; Scognamiglio, Mario; Grimaldi, Luigi Maria Edoardo; Gabelli, Carlo; Sorbi, Sandro; Binetti, Giuliano; Crepaldi, Gaetano; Franceschi, Claudio
Abstract
Background: Acetylcholinesterase inhibitors (AChEIs) have been used to improve cognitive status and disability in patients with mild to moderate Alzheimer’s disease (AD). However, while the efficacy of AChEIs (i.e. how they act in randomized controlled trials) in this setting is widely accepted, their effectiveness (i.e. how they behave in the real world) remains controversial.
Objective: To compare the effects of three AChEIs, donepezil (Aricept®), galantamine (Reminyl®) and rivastigmine (Exelon®), in an Italian national, prospective, observational study representative of the ‘real world’ clinical practice of AChEI treatment for AD.
Methods: 938 patients with mild to moderate AD collected within the framework of the Italian National Cronos Project (CP), involving several UVAs (AD Evaluation Units) spread over the entire national territory, who were receiving donepezil, galantamine or rivastigmine were followed for 36 weeks by measuring: (i) function, as determined by the Activities of Daily Living (ADL) and Instrumental Activities of Daily Living (IADL) scales; (ii) cognition, as measured by the Mini-Mental State Examination (MMSE) and the Alzheimer’s Disease Assessment Scale-cognitive subscale (ADAS-cog) [primary outcome measures]; and (iii) behaviour, as measured on the Neuropsychiatric Inventory (NPI) and Clinical Dementia Rating (CDR) scale. Moreover, all patients were genotyped for apolipoprotein E (apoE) genetic variants.
Results: No statistically significant improvement in the primary outcome measures (MMSE and ADAS-Cog) was observed with drug therapy at 36 weeks, at which point all groups had lost, on average, 1 point on the MMSE and gained 2–3 points on the ADAS-Cog scale compared with baseline. On the secondary outcome measures at week 36, all treatment groups showed a significant worsening on the ADL and IADL scales compared with baseline, while on the NPI scale there were no significant differences from baseline except for the galantamine-treated group which worsened significantly. Moreover, patients receiving galantamine worsened significantly compared with the donepezil-treated group on the IADL scale. ApoE ϵ4 allele did not influence the effect of drug therapy.
Conclusion: Over a 36-week follow-up period, no significant difference in the effects of donepezil, galantamine and rivastigmine on a variety of functional and cognitive parameters was observed in a large number of apoE-genotyped patients with mild to moderate AD recruited within the framework of a national project representative of the scenario usually encountered in actual clinical practice in Italy. The limitations (possibility of administration of lower drug doses than are used in clinical trials, relatively short follow-up period and the lack of randomization) and strengths (large number of patients, concomitant observation of the three drugs and the number of parameters assessed, including apoE genotype) of the present study are acknowledged. Our type of naturalistic study should complement clinical trials because ‘real world’ practice operates in the face of the numerous variables (e.g. health status and co-morbidities) associated with a complex disease such as AD in elderly people.
Copyright 2010 Adis Data Information BV
Topics: Uncategorized | 4 Comments »
February 5th, 2010 at 10:58 am
Joel– Thank you so much for bringing this article to your subscribers’ attention. It is MOST helpful and supports my claim, certainly re Exelon in my case (I was on it for 3 mos. with the patch when it first came out). More importantly, it strengthens my argument that Art Larsen should be tken off the Aricept that his neurologist prescribed for him about two months ago. He has gotten even more confused and is very tired all the time. His daughter noticed it when she was here last week seeing him for the first time since her wedding five months ago. I’ve emailed both his daughters the article and encouraged them to follow through with Art’s neurologist (whom he just saw a few days ago and said (according to Art) “he hasn’t given the medicine enough time to do its work.” I say B-S.
Regina
February 5th, 2010 at 5:00 pm
Joel thank you so much for putting this article on the website. It makes me feel much better about my husband refusing to take any of these drugs which were prescribed for his disease.
Sally
February 19th, 2010 at 5:58 pm
Thanks for the continued support and interest Regina. I am planning an AD prevention study for children of pts with AD who carry the gene known as Apoe4. Kindest personal regards, Joel
February 19th, 2010 at 6:00 pm
I am glad in some small way I am helping Bill. He is the one person I can truly say that was responsible for recruing me from an ad he ran in the December New England Journal of Medicine, 1985. I read it, we met in NYC first and then to Long Branch. I do hope we can find a way to slow his decline.
Let me know if I can be of any further help. The medical center at Yale has a superb group of geriatricians.
Would you want me to reach out to them for another opinion?
Kindest personal regards, Joel
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