Living with young-onset dementia in the family - a mixed method study.

Background: Studies on disease-related obstructions experienced in everyday life of younger people with dementia (YOD ≤ 65 years) and their families are encouraged.Aim: To explore how the family carers experience six predefined topics that influence the everyday life and needs of persons with YOD.Method: A quantitative and a qualitative study including family carers of persons with young-onset Alzheimer's dementia (AD) and frontotemporal dementia (FTD). Seventy-four informants responded to the Camberwell Assessment of Needs in the Elderly (CANE) and individual interviews were conducted with 13 informants.Results: Family carers of persons with YOD reported few unmet needs in the CANE assessment. Needs related to behavior and close relationships were reported significantly more frequent (p < 0.1) in persons with FTD than in persons with AD. From the qualitative data, six main themes were emphasized: daily activities turned upside down, involuntary loss of previous social network, losing close relationship, but maintaining a friendship with the spouse, unpredictable behavior adds burdens to a changing life, health and life risks, and economic insecurity for future life and caring costs.Conclusion: Whilst family carers quantitatively reported unmet needs, the individual interviews reported several major difficulties in everyday life.

Cost analysis of day care centres in Norway.

BACKGROUND: Day care services aim to offer meaningful activities and a safe environment for the attendees and a respite for family caregivers while being cost effective. This study compares the use of formal and informal care in users and non-users of day care centres designed for persons with dementia. METHOD: Users of day care designed for dementia (DC group) and non-users (NDC group) were followed over a period of 24 months or until nursing home admission (NHA) respectively death. Demographic and clinical characteristics were collected at baseline and after 12 and 24 months. The use of care was recorded by Resource Utilization in Dementia (RUD). RESULTS: A total of 257 persons with dementia participated in the study, 181 in the DC group and 76 in the NDC group. Users of day care centres cause higher costs due to the expenses for day care, while neither the use of home nursing, secondary care, informal care nor the time until NHA did show any differences between users and non-users. The overall costs were higher in the DC group at baseline and after 12 months, but this difference was no longer present at the end of the two-year study period. CONCLUSION: Our results indicate no potential cost-saving effect of day care designed for people with dementia, as the use of day care did neither result in a reduced use of care nor in a delay of NHA. Future research should balance the non-monetary benefits of day care against its costs for a full cost-effectiveness analysis, most favourable in a RCT-design.

The validity of the hospital anxiety and depression scale and the geriatric depression scale-5 in home-dwelling old adults in Norway✰.

BACKGROUND: Little is known about the validity of the Norwegian versions of the Geriatric Depression Scale-5 (GDS-5) and the Hospital Anxiety and Depression Scale-D (HADS-D). The aim of this study was therefor to validate the two assessment tools in a population of home-dwelling persons of 60 years of age and above. METHODS: A sample of 194 home-dwelling old adults with and without depressive symptoms were recruited. The participants were examined for depressive symptoms (GDS-5, HADS-D) and cognitive impairment. Sociodemographic information was collected. The participants underwent a blinded diagnostic evaluation for a depressive episode according to the diagnostic criteria of ICD-10. RESULTS: In all, 56 (28.9%) participants fulfilled criteria for a depressive episode according to ICD-10. The Receiver Operating Characteristics analyses of HAD-D and GDS-5 using the diagnostic criteria of ICD-10 for depression as gold standard was performed. For GDS-5 the Areal under the Curve was 0.81 and for HAD-D 0.75. The cut-off points of the measures that produced the highest accuracies were ≥2 for GDS-5 with a sensitivity of 73.2% and a specificity of 73.2% and ≥4 for HADS-D with a sensitivity of 70.3% and a specificity of 69.6%. LIMITATIONS: A larger sample would have given the opportunity for analyzing home dwelling old adults with and without home health care separately. The participants were talked through the self-filling questionnaires. The procedure could have influenced the participants' answers. CONCLUSION: GDS-5 and HADS-D are useful screening tools for old adults, but only fairly good to identify depression according to criteria of ICD-10.

Young-onset Alzheimer dementia: a comparison of Brazilian and Norwegian carers' experiences and needs for assistance.

OBJECTIVES: Although dementia typically occurs in older people, it can also emerge in people aged younger than 65 years in the form of young-onset dementia, the most common type of which is Alzheimer's disease (AD). However, few studies have examined the needs of persons with young-onset AD (YO-AD) and their families, and cross-cultural research on the topic is even scarcer. In response, we investigated the situations, experiences and needs for assistance of carers of persons with YO-AD in Brazil and Norway. METHODS: As part of our qualitative study, we formed a convenience sample of Brazilian (n = 9; 7 women) and Norwegian carers (n = 11; 6 women) in 2014 and 2015, respectively, and analysed data in light of a modified version of grounded theory. RESULTS: Carers' narratives from both countries revealed five common themes in terms of how YO-AD affected carers' psychological and emotional well-being, physical well-being, professional and financial well-being, social lives and need for support services. CONCLUSIONS: The infrequent differences between carers of persons with YO-AD in Brazil and Norway indicate that carers' problems are highly similar regardless of cultural differences and public services provided. Copyright © 2017 John Wiley & Sons, Ltd.

Finding of increased caudate nucleus in patients with Alzheimer's disease.

OBJECTIVES: A recently published study using an automated MRI volumetry method (NeuroQuant®) unexpectedly demonstrated larger caudate nucleus volume in patients with Alzheimer's disease dementia (AD) compared to patients with subjective and mild cognitive impairment (SCI and MCI). The aim of this study was to explore this finding. MATERIALS & METHODS: The caudate nucleus and the hippocampus volumes were measured (both expressed as ratios of intracranial volume) in a total of 257 patients with SCI and MCI according to the Winblad criteria and AD according to ICD-10 criteria. Demographic data, cognitive measures, and APOE-ɛ4 status were collected. RESULTS: Compared with non-dementia patients (SCI and MCI), AD patients were older, more of them were female, and they had a larger caudate nucleus volume and smaller hippocampus volume (P<.001). In multiple linear regression analysis, age and female sex were associated with larger caudate nucleus volume, but neither diagnosis nor memory function was. Age, gender, and memory function were associated with hippocampus volume, and age and memory function were associated with caudate nucleus/hippocampus ratio. CONCLUSIONS: A larger caudate nucleus volume in AD patients was partly explained by older age and being female. These results are further discussed in the context of (1) the caudate nucleus possibly serving as a mechanism for temporary compensation; (2) methodological properties of automated volumetry of this brain region; and (3) neuropathological alterations. Further studies are needed to fully understand the role of the caudate nucleus in AD.

Change in psychotropic drug use in Norwegian nursing homes between 2004 and 2011.

ABSTRACTBackground:We aimed to assess whether there were any changes in the use of psychotropic drugs in Norwegian nursing homes between 2004 and 2011. Also, we investigated whether the predictors of use of specific psychotropic drug groups have changed. METHODS: We conducted a secondary analysis of two cohort studies of two Norwegian nursing home samples (2004/05 and 2010/11). Multivariate models were applied. RESULTS: We found a significant decrease in the prescription of antipsychotic drugs between 2004 and 2011 (0.63 OR, 95%CI = 0.49-0.82, p < 0.001) even after adjusting for relevant demographic and clinical variables. There are only minor changes for the other psychotropic drugs. We found that (1) the use of specific psychotropic drug groups as well as the number of psychotropic drugs used was associated with more affective symptoms and (2) the use of specific psychotropic drug groups as well as the number of psychotropic drugs used was associated with lower scores on the Physical Self-Maintenance scale. CONCLUSION: This is the first study to show a robust decrease in antipsychotic drug use in nursing home patients with dementia unrelated to possible changes in case mix. The change might be explained by treatment recommendations against its use except in the most severe conditions of aggression or psychosis. Our findings indicate that it takes several years to implement scientific knowledge in clinical practice in nursing homes.

A Bifactor and item response analysis of the geriatric anxiety inventory.

BACKGROUND: Due to previously reported mixed findings, there is a need for further empirical research on the factorial structure of the commonly used Geriatric Anxiety Inventory (GAI). Therefore, the psychometric properties of the GAI and its short form version (GAI-SF) were evaluated in a psychogeriatric mixed in-and-out patient sample (n = 543). METHODS: Unidimensionality was tested using a bifactor analysis. Rasch modeling was used to assess scale properties. Sex, cognitive functioning and depressive symptoms were tested for differential item functioning (DIF). RESULTS: The bifactor analysis identified an essential unidimensional (general) factor structure but also specific local factors. The general factor comprises all the 20 items as one factor, and the results showed that the variance in the general and specific factors (subscale) scores is best explained by the single general factor. These findings were demonstrated for both versions of the GAI. Furthermore, the Rasch models identified extensive item overlap, indicating redundant items in the full version of the GAI. The GAI-SF also seems to extract much of the same information as the full form. Test scores and items have the same meaning for older adults across different demographic status. CONCLUSION: The findings support the use of a total sum score for both GAI and GAI-SF. Notably, when using the GAI-SF, no information is lost, in comparison with the full scale, thus, supporting the option of choosing the short form (version) when considered most appropriate in demanding clinical contexts.

Changes in cognitive function during psychogeriatric treatment in relation to benzodiazepine cessation.

INTRODUCTION: The aim of this study was to investigate cognitive functions after admission to a geriatric psychiatric hospital, and to study the short-term effects of cessation of benzodiazepine use on cognitive functions. METHODS: Details of benzodiazepine use and serum concentration measurements were recorded on admission. The Hopkins verbal learning test, the Stroop test, Digit Vigilance Test and the Mini Mental Status Examination were performed on admission, and after 4 weeks of hospitalization. Test results were compared for the total group of patients, as well as for benzodiazepine "continuers" and the "quitters". RESULTS: For all patients (n=224), improved performances were observed in 10 out of 12 cognitive tests. Significant improvements were seen in 4 out of 12 tests. Benzodiazepine "quitters" improved significantly more than the "continuers" (p=0.027) only on the Hopkins verbal learning test, delayed recall performance. DISCUSSION: Among elderly psychiatric patients, cognitive function improved slightly during the 4 weeks of hospital treatment, but only for one of the memory tests, the improvement was related to the cessation of benzodiazepine treatment.

Two galantamine titration regimens in patients switched from donepezil.

OBJECTIVES: In addition to inhibiting acetylcholinesterase, galantamine has allosteric-modulating activity at nicotinic receptors. This may make galantamine an attractive option for patients starting treatment for Alzheimer's disease (AD), but also for those who have not benefited from their current therapy. This study explored outcomes in subjects with AD transitioning from donepezil because of insufficient tolerability or efficacy. MATERIALS AND METHODS: Subjects previously receiving donepezil for mild-to-moderate AD were enrolled in a 12-week randomized, open-label study. After screening and a 7-day washout, subjects were randomly allocated to galantamine fast (8 mg/week increments) or slow (8 mg/4 week) titration to 16-24 mg. Efficacy outcomes included the Alzheimer's Disease Assessment Scale - cognitive subscale (ADAS-cog/11), Mini-Mental State Examination (MMSE), Clinician's Interview-Based Impression of Change - Plus Caregiver's Input (CIBIC-plus) and Alzheimer's Disease Cooperative Study - Activities of Daily Living Inventory (ADCS-ADL). RESULTS: Eighty-six of 89 patients (fast titration, n = 44; slow titration, n = 45) completed the study. At week 12, ADAS-cog/11 score improved from screening by 2.6 and 0.6 in the fast- and slow-titration arms, respectively (overall, -1.6; P = 0.002). MMSE scores improved slightly in both arms (overall, +0.9; P = 0.002). Two-thirds of patients had improvement or no change on the CIBIC-plus at week 12. ADCS-ADL scores did not change significantly from screening in either treatment arm. Galantamine was generally well tolerated; nausea (5.6%) and bradycardia (4.5%) were the most commonly reported adverse events. CONCLUSIONS: Patients in whom donepezil is ineffective or poorly tolerated may benefit from a switch to galantamine.

Homocysteine measurements in geriatric patients.

OBJECTIVE: Homocysteine measurements may be relevant in geriatric medicine as homocysteine has been identified as an independent risk factor for prevalent disorders such as occlusive arterial vascular disease, cognitive impairment and dementia. The aim of the present study was to study diagnostic correlates of plasma total homocysteine (tHcy) in geriatric in-patients. MATERIAL AND METHODS: Blood samples for the analysis of tHcy and related factors like serum vitamin B12, serum folate, red blood cell folate and clinical data were collected from geriatric patients (n=114) in stable clinical condition. RESULTS: Almost 40% of the patients had tHcy values above 20 micromol/L. tHcy correlated significantly with serum folate, serum vitamin B12, serum creatinine and congestive heart failure, but not with red blood cell folate, cerebrovascular disease, coronary heart disease or cognitive impairment. CONCLUSIONS: Hyperhomocysteinaemia seems to be frequent in geriatric patients and might primarily be an indicator of low folate and high creatinine values.

Cognitive impairments in acute lacunar stroke.

BACKGROUND: The present study investigated the prevalence of cognitive deficits in acute lacunar stroke, validated the Mini Mental State Examination (MMSE) in detecting cognitive impairments in lacunar patients, and identified predictors of such deficits. METHODS: Seventy-one patients with lacunar stroke performed a comprehensive cognitive screening between day 2 and day 7 of their stay. The test battery included Trail Making Test A, Verbal Fluency, Object Learning Test, Ullevål Aphasia Screening, and Assessment of Stroke and other Brain Damage regarding motor apraxia, rational apraxia and visuospatial ability. RESULTS: Exactly 57.7% scored outside cutoff in at least one of the cognitive tests. Using a rigorous cutoff for MMSE (28/29 points) and the test battery as comparison, the sensitivity and specificity of MMSE were 0.69 and 0.67, respectively. Only male sex was significantly related to the presence of cognitive deficits (pathologic score on at least one of the tests--odds ratio 4.41, 95% confidence interval 1.45-13.43). CONCLUSION: Many lacunar stroke patients suffer cognitive problems. Male patients are at particular risk. MMSE failed to identify 30% of the patients diagnosed with cognitive deficits, and we suggest that lacunar stroke patients be offered a comprehensive cognitive screening, even when MMSE is normal.

Apolipoprotein E epsilon4 and impaired episodic memory in community-dwelling elderly people: a marked sex difference. The Hordaland Health Study.

BACKGROUND: Among elderly people without dementia, the apolipoprotein E epsilon4 allele (APOE4) has been associated with cognitive deficit, particularly in episodic memory, but few reports are available on whether this association differs by sex. METHODS: In a community-dwelling Norwegian cohort of 2181 elderly people (55% women), aged 70-74 years, episodic memory was examined in relation to sex and APOE4 zygosity, with the Kendrick Object Learning Test (KOLT). RESULTS: Possession of at least one APOE4 allele had a modest, detrimental effect on episodic memory in women, whereas in men, heterozygotes were unaffected and homozygotes had markedly lower scores across the distribution of KOLT scores. This sex difference was found consistently in all analyses: on comparing means and medians, examining trends across quintiles, and studying the distribution of scores and the risk of cognitive impairment. Results were broadly similar when adjusted for known determinants of cognition and also when severely impaired participants were excluded. The adjusted odds ratio (OR) of cognitive impairment in women was shown to be 1.8 (95% confidence interval (CI): 1.1 to 2.8) for heterozygotes and 1.1 (0.3 to 3.7) for homozygotes; the adjusted OR in men was observed to be 1.1 (0.6 to 2.1) for heterozygotes and 10.7 (4.7 to 24) for homozygotes. CONCLUSIONS: Although the harmful effect of APOE4 on episodic memory was modest in women, the risk was found to occur in about 30%. APOE4 was observed to have a dramatic effect on episodic memory in men, but only in homozygotes, who comprised about 3% of men: the whole male homozygous group showed a marked shift to lower memory scores.

3-year study of donepezil therapy in Alzheimer's disease: effects of early and continuous therapy.

Delays in the diagnosis of Alzheimer's disease, and, therefore, delays in treatment, may have a detrimental effect on a patient's long-term well-being. This study assessed the effects of postponing donepezil treatment for 1 year by comparing patients treated continuously for 3 years with those who received placebo for 1 year followed by open-label donepezil for 2 years. Patients (n = 286) with possible or probable Alzheimer's disease (according to DSM-IV, NINCDS-ADRDA, and Mini-Mental State Examination criteria; see text) were randomized to receive donepezil (5 mg/day for 4 weeks, 10 mg/day thereafter) or placebo (delayed-start group) for 1 year. Of the 192 completers, 157 began a 2-year, open-label phase of donepezil treatment. Outcome measures were the Gottfries-Bråne-Steen scale, the Mini-Mental State Examination, the Global Deterioration Scale, the Progressive Deterioration Scale, the Neuropsychiatric Inventory, and safety (adverse events). Mixed regression analysis was used to compare changes between the groups over 3 years on the efficacy measures. There was a trend for patients receiving continuous therapy to have less global deterioration (Gottfries-Bråne-Steen scale) than those who had delayed treatment (p = 0.056). Small but statistically significant differences between the groups were observed for the secondary measures of cognitive function (Mini-Mental State Examination; p = 0.004) and cognitive and functional abilities (Global Deterioration Scale; p = 0.0231) in favor of continuous donepezil therapy. Over 90% of the patients in both cohorts experienced one treatment-emergent adverse event; most were considered mild or moderate. In conclusion, patients in whom the start of treatment is delayed may demonstrate slightly reduced benefits as compared with those seen in patients starting donepezil therapy early in the course of Alzheimer's disease. These data support the long-term efficacy and safety of donepezil.

Low blood pressure is a better predictor of cognitive deficits than the apolipoprotein e4 allele in the oldest old.

OBJECTIVE: To study the correlates of cognitive deficits in persons 80 years and older. MATERIALS AND METHODS: Data from 271 individuals between 80 and 102 years of age, drawn from a central registrar (response rate 50%) were analyzed regarding e apolipoprotein E (Apo-E) polymorphism, blood pressure (BP), homocysteine, sex, age and education as predictors for low score on Mini Mental Status Examination (MMSE). RESULTS: Low systolic and diastolic BP were highly associated with low score on the MMSE, followed by age and Apo-E e4. No relationship was found between Apo-E allele groups and BP. Homocysteine, sex, and education were only of marginal importance. CONCLUSIONS: Hypotension is an important factor for performance on the MMSE. To some extent, this was also true for having the Apo-E e4 allele. A combined effect on cognition for these two factors was not found.

Accuracy of CT scan measurements of the medial temporal lobe in routine dementia diagnostics.

BACKGROUND: Atrophy of the medial part of the temporal lobe is seen in Alzheimer's disease (AD). We studied the usefulness of CT scan measurements of the medial temporal lobe (MTL) in elderly with suspected dementia. METHODS: MTL measurements were done with callipers by three raters, blinded to the diagnosis and to each other, on scans from 110 subjects with suspected dementia from a memory clinic in Oslo, Norway and 36 participants included in the OPTIMA study, Oxford, England. RESULTS: The correlation between the MTL and the Mini-Mental State Examination (MMSE) was very low, and there was a marked overlap between Alzheimer and cognitively unimpaired subjects. The inter-rater reliability was lower on the Norwegian than on the OPTIMA scans (R = 0.48 vs R = 0.68), but this was partly explained by larger MTL readings (4.5 mm after adjustment for age, gender and MMSE sumscore) on the OPTIMA scans as the reliability was confounded by MTL width and was higher at larger MTLs. A wider scan width (3 mm vs 2 mm in the OPTIMA scans) can also contribute to differences in reliability. CONCLUSIONS: The published threshold values regarding the CT scan MTL measurements for the diagnosis of AD may be invalid when applied by other radiology departments without a local standardisation and validation.

Psychometric properties of the state part of the Spielberger State-Trait Anxiety Inventory (STAI) in geriatric patients.

BACKGROUND: A conspicuously high score on the state part of the State-Trait Anxiety Inventory (STAI) has been observed among geriatric inpatients who are neither demented nor critically ill; 43% of them had a sumscore that, according to Spielberger's criteria, would reflect clinically relevant anxiety symptoms. OBJECTIVES: To explore the reasons for this high score. METHODS: 101 geriatric inpatients and 68 healthy controls of similar age, living at home and recruited through senior citizen centres participated in a controlled cross-sectional study. RESULTS: High item-scores were more frequent on the symptom-negative items than on the symptom-positive items. Multi-group factor analysis produced two factors termed 'well-being' and 'nervousness', which had a moderate correlation (0.61). The intercept was much higher on 'well-being' than on 'nervousness', showing that a lack of well-being contributes significantly to the high score on the STAI. This confounds the sumscore. However, the geriatric inpatients nevertheless had a high score on the factor 'nervousness'. Female controls scored higher than males on both factors, whereas among the geriatric patients neither age nor gender related to them. CONCLUSIONS: The STAI state sumscore is a biased indicator of anxiety in geriatric inpatients owing to confounding by well-being. The most important cause for the observed high score on the STAI state instrument in geriatric patients relates to a reduced well-being.

A 1-year, randomized, placebo-controlled study of donepezil in patients with mild to moderate AD.

OBJECTIVE: To evaluate the long-term clinical efficacy and safety of donepezil versus placebo over 1 year in patients with mild to moderate AD. METHODS: Patients (n = 286; mean age, 72.5 years) with possible or probable AD from five Northern European countries were randomized to receive either donepezil (n = 142; 5 mg/day for 28 days, followed by 10 mg/day) or placebo (n = 144) for 1 year. RESULTS: The study was completed by 66.9% of the donepezil- and 67.4% of the placebo-treated patients. The benefit of donepezil over placebo was demonstrated by the Gottfries-Bråne-Steen (a global assessment for rating dementia symptoms) total score at weeks 24, 36, and 52 (p < 0.05) and at the study end point (week 52, last observation carried forward; p = 0.054). Advantages of donepezil over placebo were also observed in cognition and activities of daily living (ADL) assessed by the Mini-Mental State Examination at weeks 24, 36, and 52, and the end point (p < 0.02) and by the Progressive Deterioration Scale at week 52 and the end point (p < 0.05). Adverse events (AE) were recorded for 81.7% of donepezil- and 75.7% of placebo-treated patients, with 7% of donepezil- and 6.3% of placebo-treated patients discontinuing because of AE. Treatment response to donepezil was not predicted by APOE genotype or sex in this population. CONCLUSION: As the first 1-year, multinational, double-blinded, placebo-controlled study of a cholinesterase inhibitor in AD, these data support donepezil as a well tolerated and effective long-term treatment for patients with AD, with benefits over placebo on global assessment, cognition, and ADL.

High prevalence of anxiety symptoms in hospitalized geriatric patients.

OBJECTIVE: To examine the prevalence of anxiety symptoms in hospitalized geriatric patients. DESIGN: Controlled cross-sectional study. SUBJECTS: Ninety-eight geriatric in-patients and 68 healthy home-dwelling controls of similar age recruited from senior citizen centres. OUTCOME MEASURE: Anxiety measured as a current emotional state by Spielberger's State-Trait Anxiety Inventory (STAI). RESULTS: The geriatric patients scored significantly higher than the controls. Applying Spielberger's recommended cut-off of 39/40 on the STAI sumscore, 41% of the female and 47% of the male geriatric patients might be suspected of suffering from significant anxiety symptoms. Patients with chronic obstructive pulmonary disease tended to score higher; otherwise no relationship was found between the STAI sumscore and type of chronic somatic disease, nor between the STAI sumscore and number of drugs in regular use. CONCLUSIONS: STAI proved feasible for use in the elderly. The scoring on the STAI is high in geriatric in-patients. Further studies are needed to clarify to what extent this relates to a high prevalence of anxiety disorders.

Study on COgnition and Prognosis in the Elderly (SCOPE): baseline characteristics.

The Study on COgnition and Prognosis in the Elderly (SCOPE) is a multi-centre, prospective, randomized, double-blind, parallel-group study. The primary objective of SCOPE is to assess the effect of the angiotensin II type 1 (AT1) receptor blocker, candesartan cilexetil 8-16 mg once daily, on major cardiovascular events in elderly patients (70-89 years of age) with mild hypertension (DBP 90-99 and/or SBP 160-179 mmHg). The secondary objectives of the study are to test the hypothesis that antihypertensive therapy can prevent cognitive decline (as measured by the Mini Mental State Examination, MMSE) and dementia, and to assess the effect of therapy on total mortality, myocardial infarction (MI), stroke, renal function, and hospitalization. A total of 4964 patients from 15 participating countries were recruited during the randomization phase of SCOPE, exceeding the target population of 4000. The mean age of the patients at enrolment was 76 years, the ratio of male to female patients was approximately 1:2, and 52% of patients were already being treated with an antihypertensive agent at enrolment. The majority of patients (88%) were educated to at least primary school level. At randomization, mean sitting blood pressure values were SBP 166 mmHg and DBP 90 mmHg, and the mean MMSE score was 28. Previous cardiovascular disease in the study population included myocardial infarction (4%), stroke (4%) and atrial fibrillation (4%). Men, more often than women, had a history of previous MI, stroke and atrial fibrillation. A greater percentage of men were smokers (13% vs 6% in women) and had attended university (11% vs 3% of women). Of the randomized patients, 21% were 80 years of age. In this age group smoking was less common (4% vs 10% for 70-79-year-olds) and fewer had attended university (4% vs 7% for 70-79-year-olds). The incidence of MI was similar in both age groups. However, stroke and atrial fibrillation had occurred approximately twice as frequently in the older patients. The patients' mean age at baseline was similar in the participating countries, and most countries showed the approximate 1:2 ratio for male to female patients. There was also little inter-country variation in terms of mean SBP, DBP or MMSE score. However, there was considerable regional variation in the percentage of patients on therapy prior to enrolment.