The Desperate Search for Survivability

"The irony is that the science [the potential in advancing medical science's analysis of new findings, and advanced technological tools and the introduction of new pharmaceutical treatments] has never been more promising."
"How many promising drugs will be abandoned or their evaluation seriously delayed [stemming from an inability to find qualifying study participants]?"
John Dwyer, president, Global Alzheimer's Platform Foundation

"I can't remember anything for more than a few seconds."
"I'm not sure [becoming a study participant] would help me. But if it could help someone else..."
"Whether you get it [Alzheimer's] or not, watching it [progress] is terrible."
Vicki Staehr, 72, Orlando, Florida

Usually when a research project plans to study a particular topic requiring participants whose condition reflects the very singular medical problem in question, it is a simple enough matter of reaching out to physicians and to non-profit support groups aligned with that medical condition for assistance in referring typical participants who have been diagnosed and their medical conditions confirmed, qualifying them for inclusion in the project.

Not so with those suffering from the symptoms of early Alzheimer's disease. Pharmaceutical giant Eli Lilly is preparing to launch a new clinical trial and to do that and commit to the time, effort and expense, the required 375 people to take part in the trial must first be in place. There is a huge pool of 44 million Alzheimer's sufferers worldwide, 5.5-million of whom live in the United States. Potentially, it would seem the prospective volunteer participants are there, needing only to be successfully recruited.

Easier contemplated than achieved. To qualify for this research, participants must meet specific criteria; to begin with, they must fall within the age bracket of 60 to 89; have been diagnosed with mild yet progressive memory loss for the past six months and have had two types of brain scans as confirming without doubt that Alzheimer's has beset them. John Dwyer, whose Global Alzheimer's Platform Foundation is assisting in the search for qualifying participants speaks of an 80 percent screening failure rate.

The simple fact appears to be that there is no proven method that can be relied upon to result in a swift and accurate diagnosis of Alzheimer's disease. Which makes the process of finding 375 patients a difficult, time-consuming and uncertain process. The goal, to use these proposed volunteer participants' experience and progress with experimental drugs as a yardstick for potential universal treatment yet find that the research cannot recruit sufficient participants reflects an obstacle of formidable proportions.

Mr. Dwyer estimates that the search for participants would have to begin by informing 15,000 to 18,000 people in the proposed study age group of the need for volunteers. Of that number, close to two thousand would end up being part of an initial screening selection to advance toward additional tests to determine whether they qualify as study participants. And of that successful number a mere 20 per cent will meet the enrolment criteria for the Lilly trial. The study that Lilly is preparing to undertake reflects a dual-drug combination.

The cost simply to initiate the process to determine study suitability is itself daunting; brain scans, laboratory tests and memory tests cost up to $100,000 per successful candidate enrolling in a trial, and this is before the experimental treatment even begins. At the present time, over one hundred Alzheimer's studies are involved in the ongoing search for 25,000 participants to enable them to proceed with such trials.

The general experience of researchers up to the present with these clinical trials has not been successful. For the most part, researchers have identified their focal point on the protein beta amyloid since its accretion in patients' brains becomes an identifier of the process of increasing brain dysfunction. The past decade has seen trials using anti-amyloid drugs, in the hope of diminishing or even halting the inexorable progress of the disease -- trials where billions have been spent without success.

And like athletes who get worn out after similar exertions, site staff can feel exhausted, suffering from what’s known as recruitment fatigue. The downside of fatigue in the field of play is more errors and even injury; but when clinical staff get tired it often causes sluggish patient enrollment in early phase trials and decreases the chance for a win in pharmaceutical R&D.  Worldwide Clinical Trials