LY450139, A Phase III Clincal Trial on the Progression of Alzheimer’s Disease

This clinical trial is worth considering. Patients who initially receive placebo (inactive sugar pill) will at a certain point in the study be switched over to active drug, LY450139. This means every participant gets the drug. Additionally, all patients who complete this study will have the option to continue receiving LY450139 by participating in an open label study.This means you can continue receiving the drug free of charge after participation in the clinical trial.

LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease.

Primary Outcome Measures: Alzheimer’s Disease Assessment Scale – Cognition (ADAS-Cog). Alzheimer’s Disease Cooperative Study Activities of Daily Living Inventory (ADCS-ADL)

Secondary Outcome Measures:

All of these test will be conducted throughout the study.

* The Clinical Dementia Rating Scale (CDR)

* Neuropsychiatric Inventory (NPI)

* Resource Utilisation in Dementia – Lite Questionnaire

* Quality of Life in Alzheimer’s Disease (Qol-AD)

* Mini-mental State Examination (MMSE)

* A chemical marker of AD in the blood which may be lowered by LY450139.

* Energy usage (metabolism) seen on a brain scan called FDG-PET

* Brain size (volume) seen with AD on a brain scan called vMRI

* Amount of brain amyloid plaque using a brain scan called AV-45-PET

* A chemical marker (tau) known to be elevated in the spinal fluid in AD

* To measure levels of LY450139 and their effect on safety, chemical markers and effectiveness.

This is a very thorough clinical trial.

To get the specifics of the clinical trial including: purpose, eligibility, inclusion criteria and available locations go to Effects of LY450139, on the Progression of Alzheimer’s Disease as Compared With Placebo (IDENTITY-2)

Here is some additional information from the Eli Lilly website.

Eli Lilly and Company (NYSE: LLY) has announced today the start of a Phase III clinical trial studying LY450139, an investigational gamma secretase inhibitor for the treatment of mild to moderate Alzheimer’s disease. LY450139 is being tested to see if it can slow the progression associated with Alzheimer’s disease by inhibiting gamma-secretase, an enzyme that can create a sticky protein called amyloid beta. Current Alzheimer’s disease theory is that subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. By blocking gamma secretase, there is less amyloid beta formed, potentially slowing brain-cell death.

Slowing the rate of disease progression could preserve independent functioning and quality of life for Alzheimer’s patients in the milder stages of the disease, potentially delaying the onset of the severe stages of the disease. Currently available treatments for Alzheimer’s disease have no documented effect on amyloid beta. They provide modest improvements in symptoms but do not slow the underlying disease process.

The IDENTITY Trial – Interrupting Alzheimer’s Dementia by EvaluatiNg Treatment of AmyloId PaThologY

IDENTITY is a randomized, double-blind, placebo-controlled trial that will be conducted in the U.S. and 21 additional countries. As part of IDENTITY, 1,500 patients will be studied for 21 months, and an open-label extension will be available to all participants completing the study. Patients who are taking currently available symptomatic treatments for Alzheimer’s disease can continue treatment during their participation in IDENTITY. Because the IDENTITY study also incorporates a “randomized delayed start” design, even those subjects initially assigned to the placebo arm of the study will be started on active LY450139 treatment sometime before the end of the 21-month study period. Both the subjects and investigators will be blinded to the exact timing of this delayed start of study drug administration.

“Alzheimer’s is a devastating disease that destroys brain cells, affecting everything from a patient’s memory to their work and social life. Currently available medications treat the symptoms of Alzheimer’s disease but have not been shown to change its underlying progression, creating an urgent unmet medical need. Today, we are proud to announce the start of the IDENTITY clinical trial and hold hope that LY450139 will represent an advance in the attempt to slow the progression of this fatal disease. We encourage patients or their caregivers to review the enrollment criteria for IDENTITY to see if they are eligible to participate,” said Eric Siemers M.D., Medical Director, Alzheimer’s disease research for Eli Lilly and Company.

Alzheimer’s disease is a progressive neurodegenerative condition that is the most common cause of dementia in patients over 65 years of age. Estimates show that 6-8% of people over age 65 are affected by Alzheimer’s disease(1), totaling approximately 5 million people in the United States alone(2). Every 72 seconds, an American is developing Alzheimer’s disease(3), and it is the seventh-leading cause of death in the United States(4). The direct and indirect health care costs associated with Alzheimer’s disease in the U.S. are estimated to be about $150 billion(5). In 2005, the total cost worldwide was estimated at $315.4 billion(6).

Given the aging population, without the availability of medicines that delay or prevent the onset of Alzheimer’s disease, the number of affected people is expected to at least triple by the year 2050 in developed nations(7). The average duration between onset of symptoms and death due to complications of Alzheimer’s disease is about 8-10 years(8). The burden to caregivers and health care costs can increase dramatically in the late stages of Alzheimer’s disease, when patients cannot maintain independent function and are frequently bedridden.

To more completely characterize the disease-modifying effects of LY450139, a number of optional biomarker sub-studies will be available to patients. These optional sub-studies will utilize new brain-scanning techniques to determine the amount of amyloid beta plaque in the brain, employ other, more established scanning techniques to examine brain structure and function, and evaluate a number of additional biochemical measures of Alzheimer’s disease. By determining the effect of LY450139 on these objective biomarkers, a more complete understanding of the effect of LY450139 on underlying Alzheimer’s disease pathology is possible.

Additional information regarding the IDENTITY trial, including global recruitment sites, may be found by visiting www.clinicaltrials.gov or www.lillytrials.com, or by calling 1-877-CTLilly (1-877-285-4559).

About LY450139

LY450139 inhibits gamma secretase, an enzyme that cuts a protein, creating a shorter, sticky protein called amyloid beta. Alzheimer’s disease theory suggests that some subtypes of amyloid beta clump together into plaques that eventually kill off brain cells. Clinical studies have examined the effect of LY450139 on amyloid beta in blood and cerebrospinal fluid. The most frequently occurring side effects experienced in earlier clinical studies with LY450139 include diarrhea, upset stomach, and fatigue. For a more complete listing of potential side effects, prospective clinical trial participants should refer to the informed consent document.

Original content the Alzheimer’s Reading Room

The 36-Hour Day: A Family Guide to Caring for People with Alzheimer Disease and Memory Loss in Later Life

 

Gingrich urges federal help with Alzheimer’s research

clipped from www.azcentral.com Former Speaker of the House Newt Gingrich said the federal government needs to spend more on Alzheimer’s research and treatment to stave off a potential fiscal disaster. Gingrich, who met Friday with scientists and lawmakers in Phoenix, said it’s pivotal that the federal government support research to find a cure or effective treatment for a disease that afflicts one in 10 Americans over the age of 65. It makes more sense to invest significant money in research rather than fritter away money on Alzheimer’s care, Gingrich said. “Changing the oil in your car is a lot cheaper than changing your engine,” he said. “Similarly, good health research is going to be a very major component of what makes the country work better.” Gingrich is co-chair of the national Alzheimer’s Study Group, a bipartisan national task force that aims to develop a national strategy to combat the disease. Ken Alltucker The Arizona Republic

 

Life book to help Alzheimer’s patients

clipped from www.craegmoor.co.uk A charity dedicated to Alzheimer’s disease has dreamt up an innovative idea which could help to reassure sufferers and help them to remember. Alzheimer’s Support, a charity in Trowbridge, has created the concept of a ‘Life Book’, which comprises both a photo album and a scrapbook to help patients remember important occasions and events in their life. The Alzheimer’s charity helps patients to put the Life Book together themselves, picking out key pieces of information from their lives. “Being a carer for someone with Alzheimer’s is extremely physically and mentally stressful. I have to be with Don at all times. If he is left on his own he suffers extreme anxiety and descends into a wild panic. At night he wanders around the house and looks through cupboards.”It is devastating to have to deal with this and I am extremely grateful that I have Alzheimer’s Support to help me. “We had a great time doing it and Don responded really well.”

 

One in Eight People Age 65 and Older have Alzheimer’s Disease

The 36-Hour Day: A Family Guide to Caring for People with Alzheimer Disease and Memory Loss in Later Life

 

Drinking juice may delay onset of Alzheimer’s disease

Drinking fruit or vegetable juice may be better for you than you think. A new research study shows that drinking fruit or vegetable juice may delay the onset of Alzheimer’s disease.

Researchers at the Group Health Center for Health Studies in Seattle, Washington
following nearly 2,000 adults for 10 years found drinking fruit or vegetable juice more than three times a week cuts the risk of developing Alzheimer’s by 76 percent compared to drinking it less than once a week. They found having juice once or twice a week reduced risk by 16 percent.

Highlights from the Study include:

“The theory is that the brain accumulates damage due to oxidation as we age, and if you can protect the brain from that damage you can protect the person from Alzheimer’s disease and other causes of dementia,” said Eric Larson, MD.

Researchers saw the protective benefits from any type of juice. The study also found there are more antioxidants in juice than in vitamin C and E supplements.

According to Dr. Larson, juice is made using parts of the fruit with the highest concentration of natural antioxidants. “The theory is the brain accumulates damage due to oxidation as we age and if you can protect the brain from that damage, you can protect the person from Alzheimer’s disease and other causes of dementia,” he said.

In most cases, juice is produced using the core, the seeds and the skin — parts of the fruit or vegetable people do not normally consume. The food is mashed together to create a concentrate. Juice is made in cold process, so nutrients aren’t damaged by heat. Juice will usually have a defined level of purity based on percentage of fruit juice. Juice should not be confused with squash, which is usually an artificial juice that can be diluted with water.

In theory, grape, apple and orange juices are very potent in antioxidants and could be the most effective at preventing Alzheimer’s disease, according to Dr. Larson. In the study, those who did not drink fruit juice, but ate several servings of fruit per week, saw some benefit. However, those who drank juice saw the most benefit.

Study participants who drank juice once or twice a week reduced their Alzheimer’s risk by 16 percent. Those who drank juice three times per week reduced their risk by 76 percent. Before you drink 10 glasses of orange juice each day, be aware there may be threshold for antioxidant consumption. Going above that amount may not necessarily bring benefits.

More on this study as it becomes available

 

Alzheimer’s Factsheets: 2007 Alzheimer’s Disease Facts and Figures

The links provided below will take you to the factsheets and full report published by the Alzheimer’s Association.

Quote Sheet (2 pages)

FactSheet (2 pages)

2007 Alzheimer’s Disease Facts and Figures (28 pages)

 

Alzheimer’s Disease Rate Rises to More Than Five Million in the United States

Someone Develops Alzheimer’s Every 72 Seconds, According To New Alzheimer’s Association Report.

The Alzheimer’s Association today reports that in 2007 there are now more than 5 million people in the United States living with Alzheimer’s disease. This number includes 4.9 million people over the age of 65 and between 200,000 and 500,000 people under age 65 with early onset Alzheimer’s disease and other dementias.

Alzheimer’s Disease Prevalence Rates Rise to More Than Five Million in the United States

The Alzheimer’s Association today reports that in 2007 there are now more than 5 million people in the United States living with Alzheimer’s disease. This number includes 4.9 million people over the age of 65 and between 200,000 and 500,000 people under age 65 with early onset Alzheimer’s disease and other dementias. This is a 10 percent increase from the previous prevalence nationwide estimate of 4.5 million.

The greatest risk factor for Alzheimer’s is increasing age, and with 78 million baby boomers beginning to turn 60 last year, it is estimated that someone in America develops Alzheimer’s every 72 seconds; by mid-century someone will develop Alzheimer’s every 33 seconds.

These new estimates, as well as other data concerning the disease and its effects, are issued today as hundreds of advocates from across the country gather in the nation’s capitol for the Alzheimer’s Association’s annual Public Policy Forum. The report titled, 2007 Alzheimer’s Disease Facts and Figures, is being released at a hearing today chaired by Senator Barbara Mikulski. Senators Barbara Mikulski and Christopher Bond and Representatives Edward Markey and Christopher Smith have introduced bipartisan legislation to address problems identified in the Association’s report. The Association’s report details the escalation of Alzheimer’s disease which now is the seventh leading cause of death in the country and the fifth leading cause of death for those over age 65. It also offers numerous statistics that convey the burden that Alzheimer’s imposes on individuals, families, state and federal governments, businesses, and the nation’s health care system. For example:

Without a cure or effective treatments to delay the onset or progression of the Alzheimer’s, the prevalence could soar to 7.7 million people with the disease by 2030, which is more than the population of 140 of the 236 United Nations countries.

By mid-century, the number of people with Alzheimer’s is expected to grow to as many as 16 million, more than the current total population of New York City, Los Angeles, Chicago and Houston combined.

As the prevalence impact of Alzheimer’s grows, so does the cost to the nation. The direct and indirect costs of Alzheimer’s and other dementias amount to more than $148 billion annually, which is more than the annual sales of any retailer in the world excluding Wal-Mart.

“Alzheimer’s Disease Facts and Figures clearly shows the tremendous impact this disease is having on the nation; and with the projected growth of the disease, the collective impact on individuals, families, Medicare, Medicaid, and businesses will be even greater,” says Harry Johns, President and CEO of the Alzheimer’s Association. “However there is hope. There are currently nine drugs in Phase III clinical trials for Alzheimer’s several of which show great promise to slow or stop the progression of the disease. This, combined with advancements in diagnostic tools, has the potential to change the landscape of Alzheimer’s.”

According to the latest statistics from the Centers for Disease Control and Prevention, from 2000-2004 death rates have declined for most major diseases — heart disease (-8 percent), breast cancer (-2.6 percent), prostate cancer (-6.3 percent) and stroke (-10.4 percent), while Alzheimer’s disease deaths continue to trend upward, increasing 33 percent during that period.

“We must make the fight against Alzheimer’s a national priority before it’s too late. The absence of effective disease modifying drugs, coupled with an aging population, makes Alzheimer’s the health care crisis of the 21st century,” Johns said.

Medicare currently spends nearly three times as much for people with Alzheimer’s and other dementias than for the average Medicare beneficiary. Medicare costs are projected to double from $91 billion in 2005 to more than $189 billion by 2015, more than the current gross national product of 86 percent of the world’s countries. In 2005, state and federal Medicaid spending for nursing home and home care for people with Alzheimer’s and other dementias was estimated at $21 billion; that number is projected to increase to $27 billion by 2015.

The new report also highlights the impact that Alzheimer’s has on states with more than 6 in 10 (62%) having double digit growth in prevalence by the end of the decade. In addition, Alaska (+47%), Colorado (+47%), Utah (+45%), Wyoming (+43%), Nevada (+38%), Idaho (+37%), Oregon (+33%), and Washington (+33%) will experience increases ranging from one-third to one-half. The states with the largest numbers of deaths due to Alzheimer’s disease in 2003 were (1) California, (2) Florida, (3) Texas, (4) Pennsylvania, and (5) Ohio.

The Alzheimer’s Association is the first and largest voluntary health organization dedicated to finding prevention methods, treatments and an eventual cure for Alzheimer’s. For more than 25 years, the Association has provided reliable information and care consultation; created services for families; increased funding for dementia research; and influenced public policy changes.

Source Alzheimer’s Association

 

Exercise slows decline in Alzheimer’s patients

I can attest, exercise makes a difference. My mother now has the tendency to sit around all day. On those days when I can get her to go to Gold’s Gym with me she is a completely different person. The look on her face, from dull to smiling, is more than enough to tell me that exercise works to her benefit.

The article on the next page talks about the effects of exercising on Alzheimer’s patients.

“Nursing home residents with Alzheimer’s disease who participate in a moderate exercise program have a significantly slower deterioration than those who receive routine medical care, researchers have shown.”

Exercise slows decline in Alzheimer’s patients

NEW YORK (Reuters Health) – Nursing home residents with Alzheimer’s disease who participate in a moderate exercise program have a significantly slower deterioration than those who receive routine medical care, researchers have shown.

Dr. Yves Rolland, of Hospital La Grave-Casselardit in Toulouse, France, and colleagues examined the effects of a program of exercise for one hour twice weekly on activities of daily living, physical performance, nutritional status, behavioral disturbance and depression among 134 Alzheimer’s disease patients in nursing homes.

The patients were 83 years old on average. They were assigned to the exercise program, which focused on walking, strength, balance and flexibility training, or to routine medical care for 12 months.

As reported in the Journal of the American Geriatrics Society, 110 participants completed the study. Among the 56 subjects in the exercise group who completed the study, the rate of adherence to the program was about 33 percent on average.

At the end of the 12 months, the average activities-of-daily-living score was significantly more improved in the exercise group than in the routine medical care group, Rolland’s team reports.

In addition, average walking speed improved significantly more in the exercise group than in the routine medical care group at 6 months and 12 months.

However, the exercise program had no apparent effect on behavioral disturbance, depression or nutritional assessment scores.

ORIGINAL SOURCE: Journal of the American Geriatrics Society, February 2007.

 

The Alzheimer’s Drug Discovery Foundation

The Alzheimer’s Drug Discovery Foundation (ADDF), a biomedical venture philanthropy founded by the Estée Lauder family, and Elan Pharmaceuticals, Inc., a neuroscience-based biotechnology company, are pleased to announce the winners of their second annual research award program, Novel Approaches to Drug Discovery for Alzheimer’s Disease. Six recipients were selected from a highly competitive pool of 32 scientists from 6 countries.

The award winners are: Yousef Al-Abed, PhD, Associate Investigator and Director at the North Shore-Long Island Jewish Research Institute; John Cashman, PhD, Executive Director and Founder of the Human Biomolecular Research Institute; Donald Porter, PhD, Senior Scientist at Senex Biotechnology, Inc.; Juan Sanchez-Ramos MD, PhD, Professor of Neurology at the University of South Florida; D. Martin Watterson, PhD, Professor at Northwestern University Medical School; and Michael S. Wolfe, PhD, Associate Professor of Neurology at Brigham and Women’s Hospital, Harvard Medical School, Center for Neurologic Diseases. The recipients were chosen by an independent scientific review panel of 10 experts chaired by ADDF Executive Director Howard Fillit, MD, a leading geriatrician and neuroscientist.

According to Dr. Fillit, “These awardees are conducting innovative research in Alzheimer’s drug discovery. Their programs were recognized as most promising to advance the discovery of effective disease-modifying drugs for Alzheimer’s. Thanks to our collaboration with Elan, we are delighted to present grant awards totaling $520,000 for this year’s program.”

The scientists received their awards at a recent luncheon held at the St. Regis Hotel in San Francisco, CA. Ms. Nancy Cozine, ADDF President; and Dr. Lars Ekman, Elan Executive Vice President and President, Global R&D, welcomed an audience of over 35 distinguished guests to celebrate the second annual ADDF/Elan Alzheimer’s Disease Drug Discovery Awards and to recognize the recipients. During the luncheon, Ms. Cozine and Dr. Ekman both commented on the importance of this program and the ongoing need to accelerate the discovery of effective drugs to conquer this devastating disease, which impacts one in ten individuals over age 65.

Dr. Ekman stated, “Elan’s collaboration with the ADDF underscores our commitment to bringing new therapeutic options to Alzheimer’s patients and their caregivers. We are dedicated to working together to make tangible progress in the fight against Alzheimer’s. For that reason, we are proud to support the work of this year’s award recipients.”

For more information regarding this unique public charity-corporate alliance research program, contact Howard Fillit, MD, at 212-935-2402 or hfillit@alzdiscovery.org.

About the Alzheimer’s Drug Discovery Foundation (ADDF)

The Alzheimer’s Drug Discovery Foundation (ADDF) is the only public charity solely dedicated to rapidly accelerating the discovery and development of drugs to prevent, treat and cure Alzheimer’s disease and cognitive aging. To date, we have awarded $27.3 million for 183 global research programs and conferences. For more information, visit http://www.AlzDiscovery.org.

About Elan Pharmaceuticals, Inc.

Elan Pharmaceuticals, Inc. is a wholly-owned subsidiary of Elan Corporation, plc (NYSE: ELN). Elan is a neuroscience-based biotechnology company committed to making a difference in the lives of patients and their families by dedicating itself to bringing innovations in science to fill significant unmet medical needs that continue to exist around the world. Our effort to develop treatment alternatives for patients and caregivers suffering from Alzheimer’s disease includes research programs focused on modifying or halting the progression of the disease. Two programs that are currently in clinical development are immunotherapeutic approaches, in partnership with Wyeth, and a small molecule program, in collaboration with Transition Therapeutics. For additional information about the company, please visit http://www.elan.com.

——————————————————————————–

AADDF Contact:
Suzanne Grossberg
Director of External Affairs
(212)901-8008
sgrossberg@alzdiscovery.org

 

Alzheimer’s and Loneliness Linked

People who are lonely are twice as likely to develop Alzheimer’s disease, a large US study has suggested.

Source Archives of General Psychiatry

A total of 823 older persons free of dementia at enrollment were recruited from senior citizen facilities in and around Chicago, Ill. Loneliness was assessed with a 5-item scale at baseline (mean ± SD, 2.3 ± 0.6) and annually thereafter. At death, a uniform postmortem examination of the brain was conducted to quantify AD pathology in multiple brain regions and the presence of cerebral infarctions.

The study found that the risk of Alzheimer’s disease was more than doubled in lonely persons compared with persons who were not lonely. The study also concluded that Loneliness is associated with an increased risk of late-life dementia but not with its leading causes.