In early December, Eli and Lily Company announced the results of two Phase 3 drug trials confirming that the decline in functionality experienced by Alzheimer’s patients is a consequence of cognitive failure. Furthermore, the study proved that any change in the functional abilities of Alzheimer’s patient’s is merely a by-product of the drug’s impact on cognitive function and not due to any direct effect from the drug therapies.
Utilizing the Alzheimer’s Disease Cooperative Study-Activities of Daily Living Scales and the Alzheimer’s Scale-Cognitive, researchers established that cognitive defects were more evident than deficiencies in functionality in patients with mild cases of Alzheimer’s disease, that the functional deficits were an end result of cognitive dysfunction and that this correlation increased over time. The findings were published in the Journal of Alzheimer’s Disease.
The findings are important to continued efforts to develop drug treatment therapies for Alzheimer’s patients. According to Dr. Hong Liu-Seifert, the data is important because it suggests that functional changes due to any drug therapy should be considered as secondary, with the focus remaining on cognitive deficits; the primary characteristic of Alzheimer’s disease. Dr. Liu-Seifert goes on to say that both cognition and function are important for the patient and their caregiver. The study results show that any positive treatment effect on cognition will initiate change in function.
Research data was combined from Phase 3 Expedition and Expedition2 trials that were evaluating the effect of drug treatments on cognition and function. The study ascertained that if there was an improvement in function it was because of the drug’s impact on cognition. In actuality, a very small portion of the study, only 13% saw change in function, whereas 87% saw change in cognition from the drug therapies. A reverse analysis demonstrated that any effect on cognition was principally due to the direct effect of the drug therapies and a small percentage (37%) driven by the drug’s effect on function.