CHICAGO, July 30, 2008 Eisai Inc. and Pfizer Inc(NYSE: PFE) announced today results from a new open-label study that showedHispanics with mild to moderate Alzheimer's disease (AD) experiencedsignificant improvement in cognition compared to baseline after 12 weeks oftreatment with ARICEPT. This is the first clinical trial looking at an ADprescription medication exclusively in Hispanics, and is important given thehigh risk of AD among this large population. These results are consistentwith pivotal ARICEPT studies in the general population and also in studiesspecific to African Americans, as seen in the 2006 Treatment of Alzheimer's inAfrican American Patients (TAAAP) study. The Evaluating ARICEPT Treatment inHispanics (EARTH) study was presented at the 2008 Alzheimer's AssociationInternational Conference on Alzheimer's Disease and Related Disorders (ICAD).
"We know the Hispanic community is in need of increased education on thebenefits of diagnosing and treating AD early," said Dr. Oscar Lopez,professor, department of neurology, University of Pittsburgh, and the firstauthor of the EARTH poster presented at ICAD. "This news should serve as acall to action for Hispanic families to watch for early signs of AD amongtheir loved ones and speak with a doctor as soon as possible if symptoms aresuspected."
This multi-center open-label clinical trial enrolled 106 Hispanic men andwomen from across the U.S. Patients were at least 50 years of age and had adiagnosis of mild to moderate AD. In order to most accurately measure theefficacy of ARICEPT in Hispanics, unique measurement tools with littlelanguage bias were specifically selected for use in the EARTH study. Forinstance, the Fuld Object Memory Evaluation (FOME) assessment reducesdependence on spoken English, and it has been proven effective in detectingcognitive impairment and in the diagnosis of AD in Spanish-speakingindividuals. The Symbol Digit Modality Test (SDMT) is also extremelysensitive 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 improvedfrom baseline (p<0.0001) with a treatment effect that was similar to that seenin the pivotal studies for ARICEPT. The FOME, which assesses learning andmemory through common object recognition, also showed significant improvementwith ARICEPT (p=0.0042) in terms of retrieval scores. The FOME storage scoresdid not show statistically significant improvement from baseline. The SDMTmeasures speed of mental processing, attention and concentration functions,and also showed significant improvement from baseline (p<0.0001). Behavioralsymptoms and associated caregiver distress were assessed with theNeuropsychiatric Inventory (NPI). A numeric improvement in NPI total scorewas observed but did not reach statistical significance; however, the NPICaregiver Distress scale (NPI-D) total score significantly improved(p=0.0500).
The most common adverse events greater than or equal to five percent wereinsomnia (9.5 percent), dizziness (7.6 percent), diarrhea (5.7 percent) andnausea (5.7 percent).
"All too often, Hispanics dismiss the symptoms of AD as signs of normalaging and wait years before consulting a doctor," said Yanira Cruz, who has adoctorate in public health and is president and CEO of the National HispanicCouncil on Aging (NHCOA), a national organization dedicated to improving thequality of life for Hispanic communities. "This study reminds us of the valueof treating AD to slow symptoms of the disease, and I encourage primary carephysicians with Hispanic patients to start screening for signs of dementia ata younger age, potentially at 55 or 60 years."
Dr. Cruz urges more attention to diagnosis and treatment of AD amongHispanics and advises family members suspecting AD symptoms i