A randomized double-blind trial of the effects of hormone therapy on delayed verbal recall in older women.

We examined whether estradiol and norethindrone hormone therapy (HT) prevented decline in delayed verbal recall in older women with normal to mildly impaired memory functioning. This was a 2-year, randomized, double-blind, placebo-controlled trial of 142 women aged 61-87, randomly assigned to receive 1 mg 17-beta estradiol daily and 0.35 mg norethindrone 3 days/week or daily placebo for 2 years. The primary outcome was short-delay verbal recall of the California Verbal Learning Test (CVLT). To look for differences in response to HT by baseline short-delay recall, we examined the primary outcome in participants grouped according to whether their baseline scores were below average for the age group or greater than or equal to this score and according to whether they met criteria for Mild Cognitive Impairment (MCI) or not. 133 women completed 1 year of the trial and 128 completed 2 years. Prespecified covariates in all repeated measures analyses of covariance (RANCOVA) included age, education, APOE epsilon4, and prior HT use. RANCOVA showed no overall significant treatment effects at year 1 or year 2. After testing for an interaction, which was significant (p=0.02), we found that women in the HT group who scored at or above the average showed significantly less decline than the placebo group in short-delay verbal recall after 1 year, p=0.007 and 2 years, p=0.01. No treatment effects were found in women below the average in either year. When grouped according to whether the participant met criteria for MCI, the interaction between treatment group and MCI subgroup was not significant. These results suggest that benefits of estrogen exposure may be limited to those with average to above average scores on the delayed verbal recall. HT dose and formulation may have contributed to these beneficial outcomes. Replication is warranted before recommendations can be made in the clinical setting.

Risk factors for harm in cognitively impaired seniors who live alone: a prospective study.

OBJECTIVES: To identify risk factors for harm due to self-neglect or behaviors related to disorientation in cognitively impaired seniors who live alone that can be used in primary care. DESIGN: Inception cohort followed prospectively for 18 months. SETTING: Participants were referred by their primary care physicians and community service agencies or were patients of several medical units of a large teaching hospital. PARTICIPANTS: One hundred thirty-nine community-residing participants, aged 65 and older who scored less than 131 on the Dementia Rating Scale and lived alone. MEASUREMENTS: Baseline Mini-Mental State Examination (MMSE); a social resources questionnaire; presence of chronic obstructive pulmonary disease (COPD), cerebrovascular disease, diabetes mellitus, Charlson Comorbidity Index, and medication use were examined as predictors of incident harm. Informants and primary care physicians provided information about the nature of any harm at 3-month intervals over an 18-month period. An incident of harm was included if it occurred as the result of self-neglect or behaviors related to disorientation, resulted in physical injury or property loss or damage, and required emergency community interventions. RESULTS: Based on the consensual agreement of four raters, 21.6% had an incident of harm. The proportional hazards model was highly significant (P<.001) and supported by bootstrapping estimates. Four variables were significantly predictive of time to incident harm: perception of fewer social resources, poorer performance on MMSE, presence of COPD, and presence of cerebrovascular disorders. CONCLUSION: Predictors of incident harm can be identified in the primary care setting and provide direction for the early identification of those at highest risk. Validation of findings with a new cohort is necessary.