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Joel S. Ross, MD, FACP, AGSF, CMD President and Founder of Memory Enhancement Center of America
 

Joel S. Ross, MD
MD FACP AGSF CMD CPI
President and Founder
 
Memory Enhancement Center
of America, Inc.
4 Industrial Way West, 2nd Floor
Eatontown, New Jersey 07724
732.571.1535
 

Worsening Memory Associated With Later Alzheimer’s Disease

By Joel Ross | April 8, 2010

Here we go again. My readers have been hopefully paying close attention to the issue of memory loss in older adults. This subjective (meaning the person admits to it) complaint of memory impairment has always been taken seriously by specialists in the field like myself. This article from Germany now further supports the need to aggressively address this concern.

Subjective memory impairment, or mild deficits in memory that may or may not cause worry for an individual, appear to predict progression to more advanced stages of cognitive impairment and dementia, according to a report in the April issue of Archives of General Psychiatry, one of the JAMA/Archives journals.

Individuals with cognitive test results below normal ranges but who are still able to participate in most regular activities are said to have mild cognitive impairment, according to background information in the article. This condition has been established as a risk factor for Alzheimer’s disease and other forms of dementia, with 10 percent to 20 percent progressing from mild cognitive impairment to dementia each year. “The concept of mild cognitive impairment as a predementia manifestation of Alzheimer’s disease is substantiated by studies providing biologic evidence for the presence of Alzheimer’s disease in patients with mild cognitive impairment,” the authors write. “However, Alzheimer’s disease-related pathologic changes in the brain evolve several years before the onset of mild cognitive impairment.”

Frank Jessen, M.D., University of Bonn, Germany, and colleagues in the German Study on Aging, Cognition and Dementia in Primary Care Patients Study studied 2,415 adults age 75 or older who did not have cognitive impairment at the beginning of the study. Participants were asked whether they believed their memory was becoming worse and whether or not this caused worry for them (one way for researchers to gauge the severity of memory impairments). They were then followed up one and a half and three years later and tested for mild cognitive impairment and dementia.

Individuals who had memory impairment with concern at the beginning of the study were at the highest risk for conversion to any dementia, or Alzheimer’s disease-related dementia, at either follow-up. “Subjective memory impairment without worry was independently associated with increased risk for dementia,” the authors write. “This risk was roughly doubled by the presence of subjective memory impairment-related worry.”

In addition, having memory impairment at the beginning of the study and mild cognitive impairment at the first follow-up increased the risk for conversion to any dementia or dementia related to Alzheimer’s disease at the second follow-up; these individuals had the greatest risk for developing dementia.

“Not all subjects with subsequent dementia will experience or report subjective memory impairment at the pre-mild cognitive impairment stage,” they conclude. “However, if subjective memory impairment is present in a subject without cognitive impairment as evidenced by neuropsychological test results, it may inform about the risk for dementia and may contribute to individual decisions about diagnostic procedures and interventions to lower the risk factors for Alzheimer’s disease based on current knowledge.”

Arch Gen Psychiatry. 2010;67[4]:414-422.

Source
Archives of General Psychiatry

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Amyloid imaging of the future may soon come to area memory centers

By Joel Ross | March 29, 2010

Avid Radiopharmaceuticals, Cardinal Health Reach Milestone In Alzheimer’s Research
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I have been writing over the past couple of years for the need for a reliable and safe biomarker (measurement of some biological product in this case) for Alzheimer’s Disease. Perhaps we now have one! Please read below:

Currently, Alzheimer’s disease cannot be definitively diagnosed until after death, when a brain autopsy is performed on a patient and evidence of beta-amyloid plaque deposits in the brain – which are a characteristic pathology of the disease – can be found. Accurate diagnosis during life can be challenging, particularly in the early stages of Alzheimer’s, when symptoms are mild and non-definitive. However, Avid Radiopharmaceuticals, Inc. (Avid) and Cardinal Health are working together to change that.

Avid and Cardinal Health today announced that more than 100 clinical centers and more than 700 patients have now participated in a Phase III clinical trial that is testing whether Avid’s molecular imaging agent Florbetapir F 18 can detect Alzheimer’s disease in living patients. Florbetapir F 18 (also known as 18F AV-45 and Florbetapir) is used with positron emission tomography (PET) technology to detect beta-amyloid plaque deposits in the brain.

A critical factor in the successful enrollment of patients in these extensive Florbetapir clinical trials has been Cardinal Health’s ability to manufacture and deliver fluorine 18 (F 18), the raw material needed to create imaging agents like Florbetapir. Because F-18’s potency quickly begins to diminish immediately after it is produced, it needs to be manufactured in close proximity to the clinical imaging sites where it will be administered to patients.

Operating the largest network of radiopharmacies in the United States, Cardinal Health can safely and efficiently manufacture and distribute F 18 to more than 85 percent of all U.S. hospitals within three hours. The company’s unmatched nuclear pharmacy scale, combined with its comprehensive fleet and logistics capabilities have played a critical role in enabling patients, hospitals, clinics and research facilities from around the nation to participate in Avid’s groundbreaking studies.

“Over the past two years, Cardinal Health’s broad network of nuclear pharmacy and manufacturing sites has allowed us to test the efficacy of important new molecular imaging agents like Florbetapir in clinical studies throughout the United States,” said Avid’s president and CEO, Daniel M. Skovronsky, MD, PhD. “This partnership has enabled us to effectively collaborate with imaging and neuropsychiatric specialists and the broader pharmaceutical industry to evaluate whether our Florbetapir beta-amyloid PET imaging agent can provide us a window into the Alzheimer’s pathological process at its earliest, pre-symptomatic stages.”

The two companies look forward to continuing to work together to realize their shared commitment to advancing the future of molecular imaging. “We’re proud to support Avid in its quest to leverage molecular imaging to change the way chronic diseases are diagnosed and managed,” said John Rademacher, president and general manager of Cardinal Health’s Nuclear Pharmacy Services business. “By working with forward-thinking innovators like Avid to quickly and cost-effectively evaluate the efficacy of agents in the clinical trial phase of their development, we hope to also play a key role in expediting novel imaging agents like Florbetapir into commercialization following their FDA approval.”

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Change Alzhiemer’s Disease to “Amyloid Associated Memory Impairment” (AAMI)

By Joel Ross | March 15, 2010

My readers have had the opportunity to learn about amyloid and its effects on the brain (see article dated …..)    It appears this toxic, sticky material builds up in the brains of patients destined to develop memory loss perhaps as much as one or two decades before any memory lapses/loss is noted by the patient or loved one.

What this means is that the earlier we recognize the toxic effects of this poison called amyloid, perhaps better treatment outcomes can be realized

We  use the term dementia of the Alzheimer’s Disease type to describe a heretofore irreversible loss of memory and functional status with eventual loss of complete ability to care for oneself.  This is the last stage of what has been referred to as Alzheimer’s Disease.

What is the proper diagnosis to make for those who still can take care of their daily needs, still safely drive but are very forgetful, or repeat the same questions many times per day, or have a tendency to forget the day or date or even forgetting previously familiar faces and names?  Are these people to be diagnosed as Mild Cognitive Impairment, Age Associated Memory Impairment, Benign Senesent Memory Loss, Prodromal or Pre-Alzheimer’s Disease?  The answer in my opinion is NO.  Why?  Simply because we are unable to distinguish such forgetfulness that seems “benign” from the forgetfulness which progesses in to the world of dementia of the Alzheimer’s Disease type.

What I propose is to use a new term to describe patients with memory loss and amyloid deposits in the brain as having “Amyloid Associated Memory Impairment”.

It does not have the negative connotation as does Alzheimer’s Disease or dementia of the Alzheimer’s Type.  Furthermore it accurately describes what many scientists (including myself) believe is a major factor leading to the memory loss: ie, amyloid build up in the brain.

I realize that there are the Alzheimer’s Assocation and the AlzForum as well as the Alzheimer’s Foundation of America that might have some issues in changing their names, but I would say that Dr. Alois Alzheimer never intended to have his name eponymically attached to this disorder.  Rather, since he was the first to ever find the amyloid plaques in the brain (along with what is referred to as “tangles”), perhaps we should use the amyloid title for the condition.

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Dimebon a failure in the treatment of Alzheimer’s Disease patients

By Joel Ross | March 5, 2010

“The Alzheimer’s Association is disappointed to learn of the negative results from the Phase III clinical trial of latrepirdine (Dimebon),” said William Thies, Ph.D., Alzheimer’s Association Chief Medical and Scientific Officer. “People with Alzheimer’s, their families and caregivers desperately need more and better treatment options for this devastating, fatal brain disease.”

Nonetheless, the Alzheimer’s Association remains optimistic about the future prospects for better Alzheimer’s treatments and prevention strategies. Several dozen other compounds are in the pipeline for Alzheimer’s disease. We remain encouraged by the fact that drugs in the pipeline for Alzheimer’s attack the disease from a variety of angles.

“The population is aging, and we need to make significant advances soon in the treatment and prevention of Alzheimer’s. It is an overwhelming epidemic, already claiming millions of individuals, and it is on track to deplete our healthcare resources and devastate Medicare,” Thies said. “The current level of federal research funding for Alzheimer’s is unacceptable considering the many millions of people this disease affects and the huge financial impact on our economy and society. And, these numbers will grow exponentially with the aging of our population.”

According to the Association, in order to get better diagnosis, treatments and prevention for Alzheimer’s, we must address two important issues.

1. We must address the chronic underinvestment in research to ultimately solve the Alzheimer crisis. We need to get more Alzheimer drugs in the pipeline. To do this, we must increase the research investment in Alzheimer’s to levels similar to other leading causes of death, such as cancer and heart disease. Only then will we have the chance to see the same type of progress such as declining death rates, and viable lifestyle-based prevention strategies stop this epidemic. If we do not invest now, the cost of Alzheimer’s disease to taxpayers in Medicare and Medicaid costs will be $20 trillion dollars over the next 40 years equal to 25 economic stimulus bills.

2. In addition to increasing funding, it is imperative that people volunteer for Alzheimer’s clinical trials. Later this year, at the Alzheimer’s Association 2010 International Conference on Alzheimer’s Disease (ICAD) the Association is planning to launch a first of its kind tool to help match people with Alzheimer’s and caregivers with Alzheimer’s clinical trials.

Source: Alzheimer’s Association

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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

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