With the approaching launch of two exciting new clinical trials, there’s a feeling of optimism in the air.
Dr. Suzanne Craft, Professor of Gerontology and Geriatric Medicine at Wake Forest School of Medicine and Genny Matthews of the Alzheimer's Disease Cooperative Study (ADCS) joined a recent ActivistsAgainstAlzheimer’s Network teleconference to discuss the latest developments.
The SNIFF study and the A4 Trial are getting under way. Dr. Craft is leading SNIFF and the A4 Trial is led by Dr. Reisa Sperling of Harvard Medical School. Both trials are conducted through ADCS. SNIFF is enrolling participants at several sites now, with more opening over the next few months. As sites are approved, the SNIFF webpage will be updated. A4 expects to begin enrolling participants later this spring and will launch a website later this month.
Study of Nasal Insulin to Fight Forgetfulness (SNIFF)
Scientists know that the brains of people with Alzheimer’s have problems processing glucose, and there is also increasing evidence that hypertension, obesity, and diabetes are risk factors for the disease. SNIFF leverages the fact that insulin helps patients with diabetes to process glucose more effectively, and this therapeutic trial will examine the efficacy of delivering insulin through the nose.
Researchers have been working with a company developing a new, sophisticated device designed to administer insulin to the upper area of the nasal cavity. When delivered in this fashion, the drug will reach the brain in as little as 30-60 minutes. The trial is also set to collect information on the efficiency and reliability of the delivery device itself.
SNIFF will enroll 240 participants who have very early probable Alzheimer’s or a diagnosis of MCI (mild cognitiveimpairment). Dr. Craft expects they will screen three individuals for every one person that enrolls, underscoring one of the biggest challenges studies like this face - finding willing, qualified participants.
Study participants will receive nasal insulin or a placebo for a period of 12 months and will undergo testing and brain scans, along with blood and spinal fluid draws, periodically. At the end of the trial, all 240 participants will be given the opportunity to receive the active medication for 6 months.
A common question from potential enrollees: What are the risks? Dr. Craft indicated there have been smaller randomized trials involving 300-400 participants receiving nasal insulin for 3 weeks to 4 months. Only minor side effects such as a runny nose and occasional dizziness have been reported; however, long-term side effects are not yet known.
SNIFF is one of three studies being funded by the National Institutes of Health (NIH) but it’s operating on a shoestring budget of just $7.9 million. Eli Lilly will contribute a small supply of insulin and placebo; however, the company is offering no financial support.
While learning that a drug as widely available and inexpensive as insulin could help memory impairment would be a huge “win” for those afflicted, the drug companies look at things differently. The possibility of insulin as a treatment just doesn’t provide enough financial incentive to interest the pharmaceutical industry. It’s another major challenge faced by researchers.
Anti-Amyloid Treatment in Asymptomatic Alzheimer's Disease (A4 Study)
This prevention trial, led by Dr. Sperling of Harvard Medical School, is being funded by a public/private partnership and is seeking to enroll 1,000 participants with normal thinking and memory. Participants must be between the ages of 65 and 85, and although asymptomatic, they must have a positive amyloid scan to qualify.
Ms. Matthews of ADCS explained that because the study involves a significant commitment, it is estimated they will screen as many as 10,000 people to reach their enrollment goal. Participants must be willing and able to undergo required procedures, which include monthly IV infusions of the trial drug or a placebo for 36 months.
The A4 drug (solanezumab) has been found to help clear amyloid plaques, which are known to be a hallmark of Alzheimer’s disease. Serious known side effects of the medication include an overactive immune system and in extremely rare cases, fluid gathering around the brain. Reactions to monthly infusions have also been reported. Matthews noted that in general, the study is considered safe, but added that it does involve very careful monitoring. She pointed out that the drug has never been given to asymptomatic patients or such a large group of people.
This trial has an expected price tag of at least $100 million and is being funded through collaboration between NIH, Eli Lilly, the Alzheimer’s Association and other philanthropic organizations.
The future looks hopeful. Contributing to that optimism is the recent NIH announcement regarding an unprecedented agreement between ten biopharmaceutical companies and several nonprofit organizations, including USAgainstAlzheimer’s.
The Accelerating Medicines Partnership (AMP) will pool resources and expertise in an effort to hasten discovery of treatments for a number of chronic diseases, including Alzheimer’s. The consortium’s goal is to reduce the time and cost of bringing new therapies to market and members will invest $130 million over five years toward that end.
Where Can I Get More Information?
For more information on the SNIFF Study click here to find research sites. Open sites have contact phone numbers listed. When a site near you opens, call that contact number directly.
For information on the A4 Trial, including detailed eligibility criteria and a list of participating research centers, click here. The A4 Study will soon launch a website to begin recruiting.
You can also send an email to Brainlink@ucsd.edu to find out if specific sites are enrolling, if you want to be contacted when most sites are open, or if you have questions that are not answered on these websites.
Another great way to stay informed about the latest prevention trials is through the Alzheimer’s Prevention Registry. Based on the information you provide, the Registry will help match you with prevention studies in your community. Joining does not obligate you in any way to participate.
Let’s continue doing all we can to increase awareness and encourage our leaders in Washington to make fighting Alzheimer’s and other forms of dementia a top priority. They did it for cancer and HIV, and there’s no reason the same can’t happen for us.