Treatment for Alzheimer’s Shows Promise in Clinical Trial
Potential treatments to slow the progression of Alzheimer’s disease (AD) have been studied for decades with limited success; researchers have yet to identify a pharmacological agent to cure or even slow AD. Over the last few years, scientists have identified an antibody that is thought to increase the clearance of soluble amyloid plaques in the brain, the pathological hallmark of AD. The antibody, which brain researchers have identified as solanezumab, reduced brain amyloid plaque deposition in preclinical studies using transgenic mice and is now in phase 3 clinical trial examining human participants. The trial, including EXPEDITION and EXPEDITION 2, were both multinational, randomized, double-blind, placebo-controlled studies of solanezumab 400 mg in outpatients with mild-to-moderate AD. Clinical endpoints, or outcomes, were measured by the Alzheimer’s Disease Assessment Scale Cognitive subscale (to assess levels of cognitive impairment) and the Alzheimer’s Disease Cooperative Study-Activities of Daily Living functional scale (to evaluate functional ability). Patients were at least 55 years old and met criteria for probable AD based on standardized diagnostic criteria. Solanezumab was given intravenously every 4 weeks through week 76, with final evaluations occurring 4 weeks later at week 80; the total duration of the study was approximately 18 months.
A total of 1024 patients with mild AD were randomized, including 521 participants assigned to the placebo and 503 assigned to solanezumab. Results from the secondary statistical analysis of the pooled mild AD population of both EXPEDITION and EXPEDITION 2 indicated that participants may have had a slowing in cognitive decline of approximately 34% (as measured using the ADAS-Cog) and a slowing in functional decline of approximately 18% (as measured by the ADCS-iADL). The findings suggest that solanezumab may be an effective treatment strategy for slowing the progression of the abnormal accumulation of amyloid plaque in the brains of patients with AD. As a result, patients might experience significantly less cognitive and functional decline over time, which can improve overall quality of life for both the patient and their family.
The article reviewed for this post was written by Siemers et al., and published in the academic journal Alzheimer’s & Dementia (2015). Results of the study described the possible benefits of solanezumab in patients diagnosed with early AD. Based on the findings discussed, EXPEDITION 3 has been initiated and is enrolling patients diagnosed with early AD and clinical evidence of abnormal build up amyloid plaque in the brain.
For additional information on clinical trials and how you can participate in Alzheimer’s disease research, visit the Alzheimer’s Association website at www.alz.org. For more information on caring for your loved one with Alzheimer’s disease or a related dementia, call Dr. David Hart, Director of Clinical Services at Always Best Care South Bay. He can be reached at (310) 792-8666 or visit www.AlwaysBestHomeCare.com for more information.