According to Susan Worley’s recent article ‘After Disappointments, Alzheimer’s Researchers Seek Out New Paths’ for Pharmacy & Therapeutics journal, right now, the only Alzheimer’s treatments that are available are those that simply address the symptoms, but cannot modify the disease. However, researchers are revisiting earlier studies of disease-modifying treatments in hopes of proving that unsuccessful clinical trials from the past were not entirely unproductive.
John Q. Trojanowski, MD, PhD, Director of the IOA and Penn Alzheimer’s Disease Core Center (ADCC), discussed the three most important lessons that we have learned from failed clinical trials.
Lesson #1. Researchers must find a way to intervene at an earlier stage of Alzheimer’s disease, increasing the vitality of designing prevention or clinical trials that address prodromal Alzheimer’s disease.
Lesson #2. “We must use biomarkers in all patient populations to increase confidence in diagnosis and also to monitor target engagement, as well as response to therapy.”
Lesson #3. New drugs must be developed “that address other AD targets, such as tau tangles.”
Also featured in the article, Dr. Reisa Sperling, MD, Director of the Center for Alzheimer’s Research and Treatment at Brigham and Women’s Hospital and Massachusetts General Hospital and Professor of Neurology at Harvard Medical School, reiterates the significance of these lessons and emphasizes “the need to treat the right target at the right stage of disease.”
Both Trojanowski and Sperling seem to agree that pursuing these new targets through combination therapy is the way to go. Dr. Trojanowski “tend[s] to agree with colleagues who say that we are now witnessing the last of the era of monotherapy clinical trials.” He explains that in the past, researchers in other therapeutic areas have been a bit resistant to the idea of combination therapy, however, “particularly for AIDS, it has turned out to be the winning strategy.”
There is also increasing hope for the development of new technologies for diagnosing Alzheimer’s disease. Patients,families, and clinicians alike are yearning for new strategies based on imaging to replace the current and much more invasive methods such as lumbar punctures used to collect cerebrospinal fluid (CFS).
According to the article, the International Society to Advance Alzheimer’s Research and Treatment (ISTAART) is working on developing new standards for AD biomarkers, mirroring the way that blood tests can determine cholesterol, “so that eventually simple predictive and diagnostic tests can be effectively implemented” when screening for Alzheimer’s.
As for recent clinical trials studying AD, there are currently five underway which are discussed in the article.
#1. The A4 Study (The Anti-Amyloid Treatment in Asymptomatic Alzheimer’s Disease)
#2. The DIAN-TU Study (The Dominantly Inherited Alzheimer’s Network Trials Unit)
#3. The API ADAD Study (Alzheimer’s Prevention Initiative Autosomal Dominant Alzheimer’s Disease)
#4. The TOMMORROW Trial
#5. The SNIFF Study (The Study of Nasal Insulin in the Fight Against Forgetfulness)
Overall, this “new era” of Alzheimer’s disease prevention trials which combines methods of modulating beta-amyloid levels with the use of biomarkers provides the information needed to develop drugs that address non-amyloid targets and to continue moving research in the direction of combination therapy.
To read the full P&T article, including further descriptions of the current clinical trials, click here.
Image Source: www.medicinenet.com via Medical Body Scans/Photo Researchers Inc.