Eisai and Pfizer announce positive results from Alzheimer’s study in Hispanics

This multi-center open-label clinical trial enrolled 106 Hispanic men and women from across the US. Patients were at least 50 years of age and had a diagnosis of mild to moderate Alzheimer’s disease (AD). In order to most accurately measure the efficacy of Aricept in Hispanics, unique measurement tools with little language bias were specifically selected for use in the Earth study.

For instance, the Fuld Object Memory Evaluation (FOME) assessment reduces dependence on spoken English, and it has been proven effective in detecting cognitive impairment and in the diagnosis of AD in Spanish-speaking individuals. The Symbol Digit Modality Test (SDMT) is also extremely sensitive for detecting dementia and has minimal cultural bias. A third, commonly used measurement included the Mini-Mental State Examination (MMSE).

The MMSE score, which measures cognitive function, significantly improved from baseline (p<0.0001) with a treatment effect that was similar to that seen in the pivotal studies for Aricept. The FOME, which assesses learning and memory through common object recognition, also showed significant improvement with Aricept (p=0.0042) in terms of retrieval scores. The FOME storage scores did not show statistically significant improvement from baseline. The SDMT measures speed of mental processing, attention and concentration functions, and also showed significant improvement from baseline (p<0.0001). Behavioral symptoms and associated caregiver distress were assessed with the Neuropsychiatric Inventory (NPI). A numeric improvement in NPI total score was observed but did not reach statistical significance; however, the NPI Caregiver Distress scale (NPI-D) total score significantly improved (p=0.0500).