By Charles S. Wilcox, Ph.D/ November, 2017
Since the approval of Namenda in 2003, there has not been any new and novel medication approved for the treatment of mild-to-moderate, or moderate-to-severe Alzheimer’s disease.
During these subsequent fourteen years, there has been an encouraging amount of progress in the (earlier) diagnosis of Alzheimer’s, as well as, a substantial amount of non-interventional research identifying lifestyle changes one can make to reduce the odds for developing and/or delaying the onset of initial symptoms of Alzheimer’s disease. Moreover, a vast amount of data and information is leading toward an enhanced focus on earlier diagnosis and intervention, including “pre-Alzheimer’s” memory loss, sometimes called “Mild Cognitive Impairment” or “Prodromal Alzheimer’s disease.”
As of November 2017, there are many reasons for hope and increased optimism. In fact, there are 148 different [potential] Anti-Alzheimer’s medicines currently in various phases of pre-clinical and clinical development! One such medication, Crenezumab is in the later, more advanced stage of development called Phase-III. This is usually the final stage before a medicine is reviewed by FDA for possible approval as a marketed medication.
Hoffmann-La Roche Ltd. (based in Switzerland) owns Crenezumab, and is currently funding two large, 750 patients per trial, Phase-III studies in persons diagnosed with Prodromal to Mild Alzheimer’s disease. Earlier Phase-II trials with Crenezumab indicated that patients with milder symptoms of memory loss demonstrated the most positive treatment effects.
To enter these trials, participants needed to have mild memory loss, a willing and capable study partner and positive confirmation of a biomarker for Alzheimer’s. FDA defines a biomarker as, “… a characteristic that is objectively measured and evaluated as an indicator of normal biological responses to a therapeutic intervention.” For this trial, qualified candidates documented biomarker evidence of a substance called amyloid which was confirmed by either positron emission tomography [PET] scan neuroimaging and/or cerebrospinal fluid [CSF]. Crenezumab is an anti-amyloid therapy that is believed to delay disease progression rather than provide symptomatic improvement.
The first of these Phase-III Crenezumab studies [called CREAD 1] was fully enrolled about three months ago. The enrollment for CREAD-2 trial is currently advancing very well and is likely to be completed ahead of schedule. Contingent upon the results of these two trials, it is possible that we may see the first ever FDA-approved marketed medication for patients with Prodromal to Mild Alzheimer’s disease as early as 2019!
For more information on Pharmacology Research Institute visit,
Learn more about Alzheimer’s on www.alzoc.org
About Dr. Wilcox