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PubMed2001

Metabolic recovery following human traumatic brain injury based on FDG-PET: time course and relationship to neurological disability.

OBJECTIVE: Utilizing [(18)F]fluorodeoxyglucose positron emission tomography (FDG-PET), we assessed the temporal pattern and the correlation of functional and metabolic recovery following human traumatic brain injury. DESIGN AND SUBJECTS: Fifty-four patients with injury severity ranging from mild to severe were studied. Thirteen of these patients underwent both an acute and delayed FDG-PET study. RESULTS: Analysis of the pooled global cerebral metabolic rate of glucose (CMRglc) values revealed that the intermediate metabolic reduction phase begins to resolve approximately one month following injury, regardless of injury severity. The correlation, in the 13 patients studied twice, between the extent of change in neurologic disability, assessed by the Disability Rating Scale (DRS), and the change in CMRglc from the early to late period was modest (r = -0.42). Potential explanations for this rather poor correlation are discussed. A review of the pertinent literature regarding the use of PET and related imaging modalities, including single photon emission tomography (SPECT) for the assessment of patients following traumatic brain injury is given. CONCLUSION: The dynamic profile of CMRglc that changes following traumatic brain injury is seemingly stereotypic across a broad range and severity of injury types. Quantitative FDG-PET cannot be used as a surrogate technique for estimating degree of global functional recovery following traumatic brain injury.

Activities of Daily Living↗

PubMed2001

Cognitive function and frontal lobe atrophy in normal elderly adults: Implications for dementia not as aging-related disorders and the reserve hypothesis.

We examined the relations between cognitive function and age and education in the normal elderly population. As per the community-based stroke, dementia, and bed confinement prevention in the town of Tajiri, neuropsychological assessments, including the Cognitive Ability Screening Instrument (CASI), were performed for 99 randomly selected normal elderly subjects. We assessed the frontal function (working memory, word fluency, Trail-Making Tests, CASI subitems of list-generating fluency, attention, and concentration/mental manipulation), language function (proverbs, CASI subitem language), non-language function (the digit symbol test of the Wechsler Adult Intelligence Scale-Revised (WAIS-R), CASI subitem visual construction), memory (Alzheimer's Disease Assessment Scale recall/recognition, story recall, CASI subitems short and long-term memory, the Rey-Osterrieth Complex Figure Test), and the global function (CASI subitems orientation and abstraction and judgment). We found that the only test affected by age was the digit symbol test of the WAIS-R. The effects of education were distributed among various tests. There was a significant correlation between age and the frontal lobe atrophy in the lower educated group. The present findings suggest that cognitive function is spared by the aging process itself and dementia should be considered as age-related, not aging-related disorders, and that education might have a protective effect on cognitive change, supporting the reserve hypothesis.

Age Factors↗

PubMed2000

Quality of life after palliative radiotherapy in non-small cell lung cancer: a prospective study.

PURPOSE: The purpose of this study was to investigate changes in respiratory symptoms and quality of life (QoL) in patients with locally advanced and metastatic non-small cell lung cancer (NSCLC) receiving thoracic radiotherapy. Additionally, the correlation between the level of symptom relief and objective tumor response was investigated. METHODS AND MATERIALS: Sixty-five patients were entered in this prospective study. The EORTC QLQ-C30 and EORTC QLQ-LC13 were used to investigate changes in QoL. Assessments were performed before radiotherapy and 2 weeks, 6 weeks, and 3 months after radiotherapy. RESULTS: The QoL response rates were excellent for hemoptysis (79%); good for arm/shoulder pain (56%), chest wall pain (53%), and cough (49%); moderate for dyspnea (39%); and minimal for the general symptoms fatigue (22%) and appetite loss (11%). The QoL response rates for the five functioning scales of the QLQ-C30 varied from 35% for role functioning to 57% for emotional functioning. Global QoL improved in 37% of the cases. In general, there was a tendency for better palliation of symptoms and improvement of QoL among patients with an objective tumor response than among those without objective tumor response, which was statistically significant for dyspnea (p = 0.02) and social functioning (p = 0.04). CONCLUSIONS: This study confirms that conventional thoracic radiotherapy offers palliation of respiratory symptoms and improved QoL in a substantial proportion of patients with locally advanced and metastatic NSCLC. Tumor reduction is only one of the mechanisms by which palliation of symptoms and improvement of QoL is achieved.

Adult↗

PubMed1991

Phytochrome-Deficient hy1 and hy2 Long Hypocotyl Mutants of Arabidopsis Are Defective in Phytochrome Chromophore Biosynthesis.

The hy1 and hy2 long hypocotyl mutants of Arabidopsis contain normal levels of immunochemically detectable phytochrome A, but the molecule is photochemically nonfunctional. We have investigated the biochemical basis for this lack of function. When the hy1 and hy2 mutants were grown in white light on a medium containing biliverdin IX[alpha], a direct precursor to phytochromobilin, the phytochrome chromophore, the seedlings developed with a morphological phenotype indistinguishable from the light-grown wild-type control. Restoration of a light-grown phenotype in the hy1 mutant was also accomplished by using phycocyanobilin, a tetrapyrrole analog of phytochromobilin. Spectrophotometric and immunochemical analyses of the rescued hy1 and hy2 mutants demonstrated that they possessed wild-type levels of photochemically functional phytochrome that displayed light-induced conformational changes in the holoprotein indistinguishable from the wild type. Moreover, phytochrome A levels declined in vivo in response to white light in rescued hy1 and hy2 seedlings, indicative of biliverdin-dependent formation of photochemically functional phytochrome A that was then subject to normal selective turnover in the far-red-light-absorbing form. Combined, these data suggest that the hy1 and hy2 mutants are inhibited in chromophore biosynthesis at steps prior to the formation of biliverdin IX[alpha], thus potentially causing a global functional deficiency in all members of the phytochrome photoreceptor family.

Journal Article↗

PubMed2004

Infarct involution and improved function during healing of acute myocardial infarction: the role of microvascular obstruction.

Delayed contrast-enhanced cardiac magnetic resonance imaging (ceCMR) delineates infarct size. The presence of hypoenhancement consistent with microvascular obstruction (MO) signifies larger infarcts with a worse prognosis. We hypothesized that the size of the contrast defect (CD) on ceCMR in acutely infarcted myocardium may change during infarct healing and depend upon the presence of MO. Twenty-five patients underwent CMR on weeks 1 and 8 after reperfused myocardial infarction. After short-axis cine CMR was performed, gadolinium was infused and ceCMR images and matched tagged cine MR images were obtained in the three most dysfunctional short-axis slices on cine CMR. The area and transmural extent of hyperenhancement (HE) with or without MO representing total CD size were planimetered. Between week 1 and week 8, the CD area fell from 1729+/-970 mm2 at week 1 to 1270+/-706 mm2 (p<0.001), as did the transmural extent of infarction (71+/-22% to 63+/-24%, p<0.001). The decline in CD trended to be higher in patients with MO (840+/-807 mm2) than in HE (312+/-485 mm2, p<0.07). In the patient group as a whole, ejection fraction (EF) improved (56+/-9% to 60+/-10%, p=0.002) between weeks 1 and 8, but patients with MO showed no increase in EF. Segments with some HE demonstrated partial functional improvement whereas no improvement was seen in HE+MO segments. In patients 8 weeks after reperfused myocardial infarction (MI), the size of infarction by ceCMR decreases compared to week 1 post-MI, especially in those with microvascular obstruction in whom there is little improvement in regional or global function.

Adult↗

PubMed1989

Relaxation and diastole of the heart.

In the present review, we adopted the viewpoint of the physiologist looking at the global function of the heart, during relaxation and diastole, as an integrated muscle-pump system. We first focused our attention on properties of relaxation and diastole at the subcellular (SR, contractile proteins), cellular, and multicellular scales of cardiac muscle and then at the scale of the ventricle and intact global heart. At each lower scale we derived properties from experimental facts and examined the extent to which these properties could be extrapolated conceptually to the higher scale. From this muscle-pump approach, we learned that a general and fundamental property of relaxation of the heart as a muscle-pump system is load dependence, i.e., the mutually independent behavior of the time patterns of slow force decline and pressure fall and of rapid lengthening and rapid filling. Load dependence is found at all hierarchic scales, irrespective of whether it is examined under strictly isotonic-isometric or isometric-isotonic or auxotonic loading conditions and despite often substantial nonuniformity. Relaxation is governed by the interaction of the loading conditions and the two major determinants of the inactivation process, i.e., Ca2+ reuptake by the SR and the properties of the contractile proteins. Load dependence is the mere mechanical expression of the unequal contribution, during the two phases of relaxation, of these three interacting determinants of relaxation (load, SR, and contractile proteins). During force decline in isolated muscle and pressure fall in the ventricle, the properties of the contractile proteins predominate over load and SR; during muscle lengthening and rapid ventricular filling, load and SR become more important. As the relative importance of the phenomena above is different during pressure fall in comparison to rapid filling, it is not surprising that directional changes in pressure fall may not predict those in filling. We also saw that the overall time pattern of pressure fall in contrast to rapid filling may sometimes be markedly altered, e.g., with simultaneous increases in peak-dP/dt, indicating more rapid early pressure relaxation, and prolonged time constant tau, indicating slower late pressure relaxation, or vice versa. From this muscle-pump approach, it should also be remembered that optimal efficiency of the heart limits the extent to which nonuniformity may exist. At all hierarchic scales, variations in the degree of nonuniformity, however small, constitute an important physiological modulator of performance throughout systole and diastole.(ABSTRACT TRUNCATED AT 400 WORDS)

Diastole↗

PubMed2005

Long-term results of replantation of the proximal forearm following avulsion amputation.

This study reports on the long-term functional outcomes of a homogeneous series of 10 cases of successful replantation of an avulsed proximal forearm and its acceptance on the part of patients. After a minimum follow-up of 3 years (average, 4.7 years), muscular and sensory recovery was evaluated with the Medical Research Council scale, and global function according to the demerit score system of Chen (China Med 5:392-397, 1967). Subjective evaluation and patient satisfaction were investigated by means of a questionnaire. One patient was classified as grade 2, 4 patients as grade 3, and 5 patients as grade 4 according to Chen (China Med 5:392-397, 1967). However, in spite of the poor objective results, patient satisfaction was obtained in 90% of cases, and the replanted extremity was considered of help for common activities of daily living. In conclusion, replantation of an avulsed proximal forearm should be considered only in patients who are strongly motivated to maintain body integrity, and who are aware of the expected functional limitations.

Activities of Daily Living↗

PubMed2004

Residential versus community treatment of personality disorders: a comparative study of three treatment programs.

OBJECTIVE: The aim of this study was to compare the effectiveness of three treatment models for personality disorder: 1) a long-term psychoanalytically oriented residential specialist program, 2) a phased "step-down" specialist psychosocial program that included a briefer residential stay and an outpatient component, and 3) a general community psychiatric model. METHOD: One hundred forty-three patients with a personality disorder diagnosis were allocated according to geographical criteria to the three treatment conditions. Outcome was prospectively evaluated at 6, 12, and 24 months through the use of a standardized battery of instruments that included measures of general symptom severity, social adaptation, assessment of mental health functioning, frequency of self-harm and suicide attempts, and rates and duration of hospital readmissions. RESULTS: By 24 months, patients in the step-down condition showed significant improvements on all measures. Patients in the long-term residential model showed significant improvements in symptom severity, social adaptation, and global functioning, while no changes were achieved in self-harm, attempted suicide, and readmission rates. Patients in the general psychiatric group showed no improvement on any variables except self-harm and hospital readmissions. CONCLUSIONS: The results of this study suggest that for personality disorders, a specialist step-down program is more effective than both long-term residential treatment and general psychiatric treatment in the community. Replication is needed that includes a random allocation of patients to conditions to ensure that geographical factors did not account for the observed differences.

Adult↗

PubMed1994

Alterations in left ventricular shape in patients with angina and single-vessel coronary disease.

BACKGROUND: Left ventricular shape alterations, apparently independent of acute ischaemia or previous myocardial infarction, have been described in patients with stable angina. Our previous observations had been made in a group of patients with multivessel coronary disease; it was therefore not possible to establish a clear-cut anatomical relationship between the location of ischaemia and the changes in left ventricular contour. The aim of this work was to extend the previous observations by analysing left ventricular shape in patients with angina and single-vessel coronary disease, in whom the potentially ischaemic region can be easily localized. METHODS: Fifty-eight patients with stable or unstable angina were retrospectively selected if they had single-vessel disease, normal regional and global function and no previous myocardial infarction: 37 had a critical stenosis (more than 75% diameter reduction) of the left anterior descending artery and 21 had a critical stenosis of the right coronary artery. Patients with left ventricular hypertrophy or any other obvious cause of myocardial dysfunction were excluded. All patients underwent haemodynamic study. Left ventricular global shape was evaluated by calculating eccentricity and circular indices; regional curvature was measured at 90 points along the angiographic contours (right anterior oblique projection) by applying a windowed Fourier analysis. Results were compared with those obtained in 16 normal subjects. RESULTS: Patients had significant diastolic alterations in left ventricular shape, which assumed a more rounded aspect than normal. Regional curvature was significantly altered at several points pertaining to the anterior, apical and inferior segments. The pattern of changes in regional curvature was about the same in the left anterior descending and right coronary artery groups, with the involvement of regions supplied by angiographically normal arteries, although the extent of alteration was greater in patients with stable, chronic angina (more than 6 months) and in patients with stenosis of the left anterior descending artery. CONCLUSIONS: Patients with angina, no previous myocardial infarction and normal systolic function had left ventricular shape abnormalities either in the potentially ischaemic or in the remote zones. The mechanism leading to these changes is still speculative.

Adult↗

PubMed2006

Right ventricular function assessed by two-dimensional strain and tissue Doppler echocardiography in patients with pulmonary arterial hypertension and effect of vasodilator therapy.

Two-dimensional strain echocardiography is a new method for the assessment of regional contractility. Thirty-seven patients with pulmonary arterial hypertension (mean age 56.4 +/- 11 years) and 38 normal subjects (mean age 58.3 +/- 12 years) underwent 2-dimensional echocardiography and tissue Doppler echocardiographic evaluation of right ventricular (RV) global function and regional contractility. Patients with pulmonary arterial hypertension additionally underwent 6-minute walking distance tests and right-sided cardiac catheterization before and after (8 +/- 3 months) vasodilator therapy. Moderate or severe RV dysfunction was present in all patients (2-dimensional strain of the basal segment of the RV free wall: -8.8 +/- 4.1% systolic longitudinal deformation) compared with normal subjects (-24.3 +/- 4.7% systolic longitudinal deformation, p < 0.001) and was improved with vasodilator therapy after 6 to 11 months (-13.3 +/- 6.2% systolic longitudinal deformation, p < 0.001).

Adult↗

PubMed1995

The quality of psychiatric emergency evaluations and patient outcomes in county hospitals.

Quality of care is widely assumed to be related to patient outcomes, but little is known about care in relation to outcomes in county general hospital psychiatric emergency services. It was hypothesized that conformity to professional standards (technical quality) and engagement of the patient (artful care) in psychiatric emergency services evaluations would contribute to improved patient functioning (Global Assessment Scale score) and appropriate disposition. A total of 583 cases in seven facilities were analyzed. Conformity to technical standards of care was associated with retention even after constraints, biases, and admission criteria had been taken into account. Conversely, artful care was associated with lower probability of retention and improved functioning.

California↗

PubMed1997

Relationship between self-rated functional status and psychosocial stress in patients suffering from rheumatoid arthritis.

BACKGROUND: To assess relationship between psychosocial factors and self-rated functioning in rheumatoid arthritis (RA). METHODS: In 66 RA patients (mean age +/- SD = 50.8 +/- 12.6 years, women 49 (74%), illness duration mean +/- SD = 13.4 +/- 10.5 years) aspects of developmental psychosocial stress thought to influence human behavior were assessed in an in depth interview using structured biographical history. Furthermore evaluation included Trait anxiety, global functional status according to the ACR criteria, radiological staging of illness and patients' self-ratings of functioning obtained by the Health Assessment Questionnaire (HAQ). Bivariate correlations were performed using psychosocial and somatic factors and self-rated functional status. RESULTS: Scores of developmental psychosocial stress significantly correlated with interviewers scoring of nurture (r = -0.722, p < 0.001) indicating good internal consistency of interview data. Significant correlations were found between patients' scoring of functional status (HAQ) and (i) ACR criteria (r = 0.490, p < 0.0001) and (ii) score of Trait anxiety (r = 0.367, p < 0.003). There was no significant correlation between developmental psychosocial stress and HAQ score. CONCLUSION: Developmental psychosocial stress does not significantly contribute as to how RA patients perceive their functional ability. In a proportion of RA patients self-rated functional status may depend on the patients disposition (e.g. neuroticism) probably promoting impaired illness behavior (e.g. regressive tendencies) which should be considered in assessing treatment procedures.

Anxiety↗

PubMed1999

Comparison of two quality-of-life instruments for cancer patients: the functional assessment of cancer therapy-general and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30.

PURPOSE: To compare two quality-of-life (QOL) questionnaires for cancer patients, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-C30 (EORTC QLQ-C30) and the Functional Assessment of Cancer Therapy-General (Fact-G), on the basis of empirical data. PATIENTS AND METHODS: Two hundred forty-four patients with a diagnosis of breast cancer or Hodgkin's disease completed both the EORTC QLQ-C30 and the FACT-G (German language version) during the same session. Questionnaire data were analyzed on a subscale basis using correlation analysis, canonical correlation, and multiple linear regression. RESULTS: Correlations between corresponding subscales of the FACT-G and the EORTC QLQ-C30 ranged from r =.14 for the social domain (very poor agreement) to r =.66 for the physical domain (good agreement), with r values for the other domains lying between these extremes. Canonical correlation analysis for the two sets of subscales revealed that overall agreement between the two instruments was only moderate (first canonical correlation coefficient r =.85, but overall redundancy less than 40%). Of the five FACT-G subscales, only one, physical well-being, was well represented by the EORTC QLQ-C30 subscales (multiple linear regression, R(2) =.67). Only three of eight EORTC QLQ-C30 subscales (physical functioning, global QOL, general symptoms) were represented fairly well by FACT-G subscales (R(2) =.43 to.60). The lowest R(2) values (<.15; ie, virtually no representation by the other instrument) were found for the FACT-G social well-being and relation with doctors and EORTC QLQ-C30 cognitive functioning subscales. CONCLUSION: For the sample investigated, the EORTC QLQ-C30 and the FACT-G were found to measure markedly different aspects of QOL, despite considerable overlap. Replicability provided, this implies that neither of the two QOL instruments can be replaced by the other and that a direct comparison of results obtained with the two instruments is not possible.

Adult↗

PubMed2006

Quantification of left ventricular regional functions using ECG-gated myocardial perfusion SPECT--validation of left ventricular systolic functions--.

OBJECTIVE: We have developed a program to quantify regional left ventricular (LV) function and wall motion synchrony using ECG-gated myocardial perfusion SPECT (MPS). This preliminary study was undertaken to validate the use of this program for estimating regional LV systolic function. METHODS: Patients were subjected to MPS by 99mTc-sestamibi at rest. The study included 20 patients who were confirmed to have a low probability of coronary artery disease (LPG; low probability group), 19 heart disease patients who were examined by MPS and equilibrium radionuclide angiography (ERNA) (ERG; ERNA group), and 24 patients who were examined by MPS and 2-dimensional echocardiography (2DE) (2DEG; 2DE group). The values of the ejection fraction (EF) and peak ejection rate (PER) were estimated. The global functions evaluated by this program were compared with those obtained by ERNA in the ERG. For regional assessment, the reference values of the functional indices were obtained for 17 LV segments in LPG. The Z score, (reference average value of the segment--patient's value of the segment)/reference standard deviation of the segment, was used for the evaluation of regional functions; a score equal to or greater than 2 was defined as abnormal. Semiquantitative visual interpretation of 2DE was used as the standard to assess wall motion. The sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of these criteria and the relationship between 2DE grading and Z scoring were validated in 2DEG. RESULTS: The values of the global EF and PER evaluated by this program correlated with those determined by ERNA (r = 0.76 and 0.58, respectively; p < 0.005 and 0.01, respectively). The sensitivities of regional EF and PER for segmental wall motion abnormalities were 86.7% and 68.7%, respectively; their specificities were 86.7% and 95.5%, respectively; their PPVs were 64.3% and 79.2%, respectively; and their NPVs were 96.0% and 91.7%, respectively. The Z scores of these indices significantly correlated with the scores determined by 2DE (rs = 0.70 and 0.68, respectively; p < 10(-10)). CONCLUSION: The potential of this program to quantify the regional systolic function was validated.

Aged↗

PubMed1998

Convergent and discriminant validity of overall defensive functioning.

We examined the validity of the construct of overall defensive functioning and its discrimination from standard diagnostic assessments. Within a multisite field trial, patients received intake diagnostic interviews by clinicians who made standard axis I through V diagnoses, then rated defense mechanisms using the Defense Mechanism Rating Scales (DMRS). Patients filled out self-report measures of distress and defenses, the SCL-90-R, and Defense Style Questionnaire (DSQ). Overall defensive functioning (ODF) scales were derived from both the DMRS and the DSQ. Overlap between clinical and self-report ratings of defenses was modest. By two different methods of factor analysis, followed by confirmatory factor analysis, clinical ratings of ODF were clearly discriminable from axis I, axis II personality disorders, current and usual global functioning, and subjective distress. ODF measured by the DSQ was not clearly discriminated from subjective distress ratings, consistent with the hypothesis that subjective distress may distort conscious derivatives of actual defensive processes. The DSQ alone probably should not be considered as a substitute for observer-rated assessment of defensive functioning, although further study of the issue is warranted.

Defense Mechanisms↗

PubMed2004

New drugs for the treatment of attention-deficit/hyperactivity disorder.

Attention-deficit/hyperactivity disorder (ADHD) is the most common neuropsychiatric disorder of childhood. Recent research indicates that ADHD most often persists into adolescence and adulthood, and is associated with impairments in academic, social and occupational functioning. The ADHD diagnosis is based on history and clinical examination. There are no objective laboratory measures for diagnosis. ADHD is largely heritable. Its underlying pathophysiology has been theorised to include dysregulation of inhibitory noradrenergic frontocortical activity on dopaminergic striatal structures. Evidence shows that ADHD is highly responsive to pharmacological treatments resulting in global functional improvements. Although pharmacotherapy is recognised as the most effective treatment, additional components to optimise ADHD management include proper educational placement, parent management training and social skills development. Central nervous system stimulants, specifically methylphenidate and amphetamine, remain first-line pharmacological treatments. Atomoxetine, a selective noradrenergic re-uptake inhibitor, is the first non-stimulant compound to receive FDA approval for paediatric and adult ADHD. Other medication classes, including alpha-agonist antihypertensives, tricyclic antidepressants, other antidepressants such as buproprion, and the wake-promoting agent modafinil, are prescribed in off-label therapy. Ongoing development of new ADHD medications is expected to emphasise alternative and extended-release delivery systems and non-stimulant compounds.

Amphetamines↗

PubMed1999

Pain intensity processing within the human brain: a bilateral, distributed mechanism.

Functional imaging studies of human subjects have identified a diverse assortment of brain areas that are engaged in the processing of pain. Although many of these brain areas are highly interconnected and are engaged in multiple processing roles, each area has been typically considered in isolation. Accordingly, little attention has been given to the global functional organization of brain mechanisms mediating pain processing. In the present investigation, we have combined positron emission tomography with psychophysical assessment of graded painful stimuli to better characterize the multiregional organization of supraspinal pain processing mechanisms and to identify a brain mechanism subserving the processing of pain intensity. Multiple regression analysis revealed statistically reliable relationships between perceived pain intensity and activation of a functionally diverse group of brain regions, including those important in sensation, motor control, affect, and attention. Pain intensity-related activation occurred bilaterally in the cerebellum, putamen, thalamus, insula, anterior cingulate cortex, and secondary somatosensory cortex, contralaterally in the primary somatosensory cortex and supplementary motor area, and ipsilaterally in the ventral premotor area. These results confirm the existence of a highly distributed, bilateral supraspinal mechanism engaged in the processing of pain intensity. The conservation of pain intensity information across multiple, functionally distinct brain areas contrasts sharply with traditional views that sensory-discriminative processing of pain is confined within the somatosensory cortex and can account for the preservation of conscious awareness of pain intensity after extensive cerebral cortical lesions.

Adult↗

PubMed1999

Efficacy and safety of rivastigmine in patients with Alzheimer's disease: international randomised controlled trial.

OBJECTIVES: To assess the effects of rivastigmine on the core domains of Alzheimer's disease. DESIGN: Prospective, randomised, multicentre, double blind, placebo controlled, parallel group trial. Patients received either placebo, 1-4 mg/day (lower dose) rivastigmine, or 6-12 mg/day (higher dose) rivastigmine. Doses were increased in one of two fixed dose ranges (1-4 mg/day or 6-12 mg/day) over the first 12 weeks with a subsequent assessment period of 14 weeks. SETTING: 45 centres in Europe and North America. PARTICIPANTS: 725 patients with mild to moderately severe probable Alzheimer's disease diagnosed according to the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, and the criteria of the National Institute of Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association. OUTCOME MEASURES: Cognitive subscale of the Alzheimer's disease assessment scale, rating on the clinician interview based impression of change incorporating caregiver information scale, and the progressive deterioration scale. RESULTS: At the end of the study cognitive function had deteriorated among those in the placebo group. Scores on the Alzheimer's disease assessment scale improved in patients in the higher dose group when compared with patients taking placebo (P<0.05). Significantly more patients in the higher dose group had improved by 4 points or more than had improved in the placebo group (24% (57/242) v 16% (39/238)). Global function as rated by the clinician interview scale had significantly improved among those in the higher dose group compared with those taking placebo (P<0.001), and significantly more patients in the higher dose group showed improvement than did in the placebo group (37% (80/219) v 20% (46/230)). Mean scores on the progressive deterioration scale improved from baseline in patients in the higher dose group but fell in the placebo group. Adverse events were predominantly gastrointestinal, of mild to moderate severity, transient, and occurred mainly during escalation of the dose. 23% (55/242) of those in the higher dose group, 7% (18/242) of those in the lower dose group, and 7% (16/239) of those in the placebo group discontinued treatment because of adverse events. CONCLUSIONS: Rivastigmine is well tolerated and effective. It improves cognition, participation in activities of daily living, and global evaluation ratings in patients with mild to moderately severe Alzheimer's disease. This is the first treatment to show compelling evidence of efficacy in a predominantly European population.

Activities of Daily Living↗