Crenezumab Now in Phase-III of Development

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,

Website: http://priresearch.com/Studies/MildMemoryLoss

Facebook: https://www.facebook.com/PRIResearch/

Learn more about Alzheimer’s on www.alzoc.org

 

About Dr. Wilcox 

Dr. Charles Wilcox is the Executive Director at The Pharmacology Research Institute [PRI] –San Fernando Valley/Encino, Los Alamitos/Long Beach, Orange County/Newport Beach, where he has worked since 1978. PRI has been on the leading edge of clinical research, including matters of brain health, since 1975. His research at PRI has been published in numerous scientific journals and presented at more than 90 scientific conferences, all around the world. A native Southern Californian, Dr. Wilcox has also been the Keynote Speaker at California Institute of Technology on Alzheimer’s Disease Research and Caregiving.  He is a member of the 25-Year Distinguished Speakers’ Bureau for the Los Angeles Alzheimer’s Association and he has been an invited Guest Speaker to a number of organizations in the greater Los Angeles and Orange County areas, as well as nationally and internationally.
2018-01-23T11:35:05+00:00November 30th, 2017|Clinical Research|