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Objective: To investigate potential associations between cognitive function and/or impairment and age-related macular degeneration (AMD) and visual impairment in the Age-Related Eye Disease Study (AREDS)., Methods: The AREDS is an 11-center natural history study of AMD and age-related cataract. The AREDS Cognitive Function Battery was administered to 2946 participants. The battery consists of 6 neuropsychological tests measuring performance in several cognitive domains. The Dunnett multiple comparison test was used to identify differences by AMD and visual acuity severity. The relationship with cognitive impairment was also assessed using logistic regression., Results: Mean scores of instruments in the AREDS Cognitive Function Battery declined with increased macular abnormalities and reduced visual acuity. After adjustment for age, sex, race, education, smoking status, diabetes mellitus, hypertension, and depression, increased macular abnormalities (trend P value <.05) reduced mean cognitive function scores as measured by the Modified Mini-Mental State Examination and the Wechsler Logical Memory Scale. Reduced vision was found to be associated with reduced mean cognitive function scores as measured by the Modified Mini-Mental State Examination and letter and verbal fluency tasks. Persons with vision worse than 20/40 OU were more likely to be cognitively impaired (Modified Mini-Mental State Examination score <80) (odds ratio, 2.88 [95% confidence interval, 1.75-4.76]) compared with persons with visual acuity of 20/40 or better OU., Conclusion: These data suggest a possible association of advanced AMD and visual acuity with cognitive impairment in older persons.

Purpose: To determine whether the AREDS Telephone Battery can be substituted for the In-Clinic Cognitive Function Battery to assess cognitive function, so that participants could still provide follow-up information without having to come to the clinic., Methods: Correlation analysis was performed on scores of the following in-clinic and telephone administrations: 1) Modified Mini-Mental State Examination (3MS), conducted in person vs. Telephone Interview Cognitive Status (TICS-M); 2) Wechsler Memory Scale-III (WMS-III), Logical Memory I and II; 3) Digits Backwards (a sub-test of the WMS-R); 4) Verbal Fluency; and 5) Letter Fluency (F,A,S)., Results: A total of 1,738 AREDS participants completed an In-Clinic Battery and a Telephone Battery within twelve months. Significant positive correlations were found for all tests, ranging from rho = 0.89 between the 3MS and TICS-M scores (95% CI; 0.88 - 0.90), to rho = 0.71 for Letter Fluency (95% CI; 0.68 - 0.74)., Conclusion: The linear relationships between the In-Clinic Battery and Telephone Battery scores support the hypothesis that the Telephone Battery is an appropriate substitute for participants who are unable to complete an in-clinic assessment of cognitive function.

Participants in the Age-Related Eye Disease Study were randomly assigned to receive daily antioxidants (vitamin C, 500 mg; vitamin E, 400 IU; beta carotene, 15 mg), zinc and copper (zinc, 80 mg; cupric oxide, 2 mg), antioxidants plus zinc and copper, or placebo. A cognitive battery was administered to 2,166 elderly persons after a median of 6.9 years of treatment. Treatment groups did not differ on any of the six cognitive tests (p > 0.05 for all). These results do not support a beneficial or harmful effect of antioxidants or zinc and copper on cognition in older adults.

Oxidative damage to the retina has been proposed as a risk factor for age-related macular degeneration (AMD). Dietary or supplemental antioxidants may play a protective role. The Age-Related Eye Disease Study (AREDS), a randomized, multicenter, placebo-controlled clinical trial designed to test the effect of pharmacologic doses of antioxidants and zinc on the incidence and progression of AMD, reported a beneficial effect of high-dose supplements, taken for approximately 6 years, in delaying the progression of intermediate AMD to advanced AMD. AREDS and subsequent research on dietary intake or supplement use have not indicated a protective role of antioxidant or zinc intake or supplement use in the incidence or prevalence of early AMD. Numbers of cases were insufficient to investigate effects on late AMD. Persons with intermediate AMD and without contraindications should consider using antioxidant and zinc supplements. There is no evidence to date that earlier use conveys benefit.

Evidence from animal, human cross-sectional, case-control, and prospective studies indicate that hormone replacement therapy (HRT) is a promising treatment to delay the onset of symptoms of dementia. The Women's Health Initiative Memory Study (WHIMS) is the first double-masked, randomized, placebo-controlled, long-term clinical trial designed to test the hypothesis that HRT reduces the incidence of all-cause dementia in women aged 65 and older. WHIMS, an ancillary study to the Women's Health Initiative (WHI) funded by the National Institutes of Health, will recruit a subgroup of women aged 65 and older from among those enrolling in the HRT trial of the WHI. The WHI clinical centers and 10 affiliated satellites plan to enroll approximately 8300 women into WHIMS over a 2-year period. Participants will be followed annually for 6 years, receiving cognitive assessments via the Modified Mini-Mental State (3MS) Examination. Women who screen positively for cognitive impairment on the basis of an educational and age-adjusted 3MS cutpoint proceed to more extensive neuropsychological testing and neurologic evaluation. Each woman suspected to have dementia then undergoes a series of laboratory tests that confirm the clinical diagnosis and classify the type of dementia. WHIMS is designed to provide more than 80% statistical power to detect a 40% reduction in the rate of all-cause dementia, an effect that could have profound public health implications for older women's health and functioning.

The past decade has seen a substantial increase in the number of individuals affected by dementia. Dementia places a tremendous personal and economic burden on millions of patients and caregivers annually. Consequently, many scientists have been searching for a treatment for dementia to avoid the imminent public health crisis that will occur if this trend continues. Primary and secondary prevention studies, as well as animal research, demonstrate the potential for hormone replacement therapy (HRT) as an efficacious treatment for dementia. Recently, the Women's Health Initiative-Memory Study began the first randomized, longterm clinical trial to test the hypothesized role of HRT at the onset and in the progression of dementia in women. Researchers also are investigating the potential of other treatments for dementias, such as nonsteroidal anti-inflammatory drugs and free radical scavengers.

This article reviews the international adaptation and use of generic health-related quality-of-life (HRQL) measures over the last several years. It focuses, as examples, on the Nottingham Health Profile (NHP), the Sickness Impact Profile (SIP), the Medical Outcomes Study Short-Form 36 Item Health Survey (MOS SF-36), the EuroQoL, Dartmouth Primary Care Cooperative Information Project (COOP) chart system, the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) and the World Health Organization's WHOQOL. These instruments exemplify several different models for developing or adapting HRQL measures described in the literature, each model choosing unique approaches to the process of validation for cross-national use. There has been considerable scientific activity in recent years aimed at advancing the capabilities for international HRQL assessments. Whereas prior adaptation work was focused exclusively on translation issues, recent work has begun to rely on common methodology for translation and validation of key measurement properties across language versions. Although the major HRQL measures reviewed have not yet reached the point at which there is sufficient evidence for measurement equivalence across different language versions, internationally coordinated projects are planned and under way for these instruments to advance and refine this capacity. Preliminary evidence suggests that there are few prominent differences between countries in ranking of health states that are representative of major HRQL dimensions, and in the levels of impact of illnesses on well-being within those dimensions. Future studies should collect additional psychometric data to more fully quantify measurement equivalence among the various language versions in which each instrument is available. Additionally, more work is required to address cultural differences within nations or language groups.