September is World Alzheimer’s Month, an event designed to bring global attention to this devastating disease. September comes on the heels of my mom’s death from Alzheimer’s in August only three years ago.
Last year I noted the event from the summit of Mt. Kilimanjaro in Africa as I was nearing the completion of “The 7 Summits Climb for Alzheimer’s: Memories are Everything” project. In the course of only 9 months, I climbed the highest mountain (including Everest) on each continent to send a message of hope, need and urgency that Alzheimer’s is a disease with no cure and needs more public awareness, education and research funding.
Of note, Alzheimer’s Disease (AD) is the only disease in the top ten with no disease-modifying treatment or cure and kills more Americans each year than breast and prostate cancer combined.
I am continuing my work today with more climbs and public speaking.
By the Numbers
The cases of AD continues to grow at a staggering rate. In 2012, every 68 seconds (from 70 seconds) a new case is diagnosed in the US and a mere 4 seconds worldwide. The costs of caring for an individual is growing significantly and the toll on caregivers continues to be the silent story of the widespread devastation Alzheimer’s bring to families. It is not a good story.
If you have followed me, you know these numbers, but they deserve repeating as they are shocking with over 5.4 Americans and 35 million worldwide having AD. The Alzheimer’s Association provides this insight:
◦ Every 68 seconds, someone in America develops Alzheimer’s disease;by mid-century someone will develop Alzheimer’s disease every 33 seconds.
◦ Alzheimer’s is the 6th leading cause of death in the United States. It is the 5th leading cause of death for those over the age of 65.
◦ People with Alzheimer’s and other dementias cost Medicaid 19 times more than older people without these conditions.
◦ 1 in 8 people age 65 and older has Alzheimer’s and nearly 1 in 2 over age 85 has it.
◦ 1 in 7 people diagnosed with Alzheimer’s disease live alone.
Please re-read these facts and let them sink in, especially the last one.
Disappointing Clinical Trials
Over the summer of 2012, there was discouraging news on the drug front with three clinical trials yielding disappointing results. These results dashed the hopes of millions. That said, I want to preface the details with my belief that there are no “failures” in medical research, only lessons. These trials will yield lessons for research efforts for years to come.
Two drugs, bapineuzumab and solanezumab, are categorized as disease modifying drugs or immunotherapies. They leverage the notion of using our own antibodies to clear or block the formation of brain plaques formed by buildup of amyloid-beta proteins that are signs of AD. Researchers focused on finding antibodies that can stick to amyloid-beta, with the idea that this could help people’s own immune systems dissolve plaques or prevent them from forming.
The work performed by Janssen Alzheimer Immunotherapy R&D LLC (a joint effort of Johnson & Johnson and Pfizer), with the drug bapineuzumab failed to meet the objectives of their clinical trial. It had high hopes of slowing the progression of the amyloid proteins in individuals with the gene ApoE4 that suggested a predisposition for developing Alzheimer’s. There were several clinical trials involving individuals with, and individuals without, the gene; however the trials showed no benefit over placebos and was halted. Several thousand individuals participated in these lengthy trials. The trial used an intravenous form of application but it was reported that a Phase II study of a subcutaneous formulation of the drug would continue. read the press release and this one
While a setback, I like this quote:
“While we are disappointed in the results of the two bapineuzumab IV studies, particularly in light of the urgent need for new advancements in Alzheimer’s disease, we believe that targeting and clearing beta amyloid remains a promising path to potential clinical benefits for people suffering from this disease,” said Husseini K. Manji, M.D., Global Therapeutic Area Head for Neuroscience, Janssen Research & Development, LLC. “Janssen remains strongly committed to tackling the enormous unmet medical needs in Alzheimer’s disease. We believe the trial results will provide a rich data set that will advance our understanding of this complex disease and inform future research in this field. Studies with other compounds in earlier stages of development in the AIP portfolio are continuing and future development strategies will be discussed jointly by the alliance partners.”
The other trial that had a high public profile was from Eli Lilly with a drug called solanezumab. It also attacked AD from the amyloid angle but proved not to slow the progression either. This clinical trial involved more than 2000 patients.
However, when the data from the Lilly trial was sliced in a different way, there were some signs of encouragement that it might be helpful in patients with mild symptoms but not those with the moderate disease. A different clinical trial will continue as planned and Lilly stated their belief that the “amyloid hypothesis” remains valid. read the press release
One thought on why these approaches did not meet expectations is due to an increasing understanding that AD begins much earlier than was once believed, perhaps 20 or 30 years before symptoms appear to family or even physicians. Thus by starting treatment even at the first sign, it may be too late to slow the progression.
The Research Continues
Technology Review reports that Genentech’s upcoming study of creneuzumab, another anti-amyloid antibody, will test the drug on about 300 people with a genetic mutation that nearly guarantees they will develop Alzheimer’s. Participants will receive the drug while they are still healthy, making the study the first large-scale effort to learn if antibodies can actually prevent the disease as opposed to slowing the progression.
Meanwhile, the Wall Street Journal reports that other efforts continue:
- Baxter International expects late-stage, or Phase 3, clinical results for Gammagard in Alzheimer’s patients. Gammagard is currently used to treat patients with immunodeficiency diseases, but it is thought to contain antibodies that could remove amyloid from the brain. One caveat: Even if the clinical results are positive, Baxter will have to figure out how to manufacture enough of the product because it is derived from blood plasma.
- Merck expects to begin clinical studies in Alzheimer’s patients by year end for MK-8931, its so-called “BACE” inhibitor, short for B-amyloid precursor protein site cleaving enzyme. The drug is designed to essentially prevent the buildup of amyloid in the brain, rather than reduce amyloid after it has built up.
- Darryle D. Schoepp, senior vice president and franchise head for neuroscience at Merck Research Laboratories, said “there’s strong genetic data” suggesting that reducing production of amyloid peptides at their source in the brain may protect against Alzheimer’s disease. Other companies including Lilly also are developing BACE inhibitors.
- Roche’s crenezumab, an antibody targeting amyloid, is being studied in cognitively healthy people in Colombia who are likely to develop Alzheimer’s due to their genetic history, to test whether it can prevent the disease. Roche’s Genentech unit is collaborating with the Banner Alzheimer’s Institute and the National Institutes of Health on the trial.
- Cancer drug bexarotene was shown to reverse Alzheimer’s symptoms in mice. A startup company called ReXceptor Therapeutics plans to begin human testing to determine whether the mice findings translate to humans. The caveat: Positive findings in animal studies often fail to translate into human benefits.
- Another hypothesis for Alzheimer’s is that so-called tau proteins in brain cells malfunction, leading to Alzheimer’s symptoms. TauRx Pharmaceuticals Ltd. is running clinical trials of a drug that targets the tau proteins. Merck and other companies also are exploring compounds that target tau.
More Investment needed
USAgainstAlzheimer’s George Vradenburg notes that the National Institutes of Health (NIH) investment in Alzheimer’s research ($480m) pales in comparison with cancer ($6B) and other terrifying disease. He calls for a huge increase in investment along the order of the one made for HIV/AIDs where a $10B investment has saved an estimated $1.4 trillion in costs and unlimited trauma for millions. Alzheimer’s affects more than five times as many Americans as AIDS.
Again, let that sink in: $480 million versus $6 Billion.
Meanwhile the best defense all of us can have against age related dementia is exercise according to many experts. The Cure Alzheimer’s Fund’s Dr. Rudy Tanzi is quoted “… exercise is key to preventing Alzheimer’s onset: “During exercise, the brain turns on the enzymes that break down beta amyloid.”
A great way to exercise and raise money at the same time is to participate in your local Alzheimer’s Association annual walk.
Tell your Representative
Lat year, the National Alzheimer’s Project Act was signed into law but had limited funding from Congress. This is the currently unfunded goal for 2013:
To help accelerate this urgent work, the President’s proposed FY 2013 budget provides a $100 million increase for efforts to combat Alzheimer’s disease. These funds will support additional research ($80 million), improve public awareness of the disease ($4.2 million), support provider education programs ($4.0 million), invest in caregiver support ($10.5 million), and improve data collection ($1.3 million).
Under the direction of the Leaders Engaged on Alzheimer’s Disease (LEAD), a large scale effort is being made to collect 1 million signatures on a petition to send to congress to fund the acts. Please click on this link to sign the petition. The petition is simple and compelling. I know from my meetings with Congress, the single most effective way of influencing your government is by talking to them directly. This is the petition:
I am committed to stopping Alzheimer’s disease. I call on the President and Congress to dedicate all resources necessary to fulfill the commitment of the National Plan to Address Alzheimer’s Disease:
* Prevent and effectively treat Alzheimer’s disease by 2025
* Strengthen the quality of care and expand support for people with Alzheimer’s disease and their families
* Enhance public awareness and engagement about the devastating consequences of this disease
I stand with the five million of my fellow Americans who are living with Alzheimer’s disease and their 15 million family caregivers. We are united in the belief that ending this ravaging disease must be a national priority. Stopping Alzheimer’s disease is scientifically possible, economically necessary, and morally imperative. Today, Alzheimer’s disease is the sixth leading cause of death and the only illness among the top ten for which there is no known effective prevention, disease modifying treatment, or cure. Unless this changes, our nation will be overwhelmed by as many as 16 million Americans facing Alzheimer’s by 2050 at an annual cost of over $1 trillion. The President and Congress must act immediately and decisively to accelerate our investment to stop Alzheimer’s disease.
I will be speaking at several events over the next few months that I hope you can attend. My presentation is of my 7 Summits Climbs and my own personal story of Ida Arnette, and the impact of Alzheimer’s.
- September 14 2012: Las Vegas – National Association of Social Workers, Nevada Chapter, Opening Keynote
- September 27 2012: New Haven, Connecticut – Yale University Masters Tea
- October 7 2012: Knoxville, TN – Pat Summitt Foundation fund raiser, Keynote see the details
- October 25 2012: Denver – Alzheimer’s Association Annual Education Symposium, Closing Keynote
Memories are Everything