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B Vellas

Publications and source records attributed to B Vellas.

At least 19 recordsLinked to original sources
PubMed2006

The GuidAge study: methodological issues. A 5-year double-blind randomized trial of the efficacy of EGb 761 for prevention of Alzheimer disease in patients over 70 with a memory complaint.

BACKGROUND: Preventive approaches in the field of Alzheimer disease (AD) is important but these trials raise many questions. Which protective factor should be studied? What population should be studied? With which principal and secondary criteria? We present here the design of the ongoing GuidAge Study. In the past, several studies suggest that Ginkgo biloba could have a potential benefit effect on cognitive function. The aim of the GuidAge Study is to evaluate the efficacy of 240 mg/d of EGb 761 in the prevention of AD. METHODS: GuidAge is a 5-year double-blind randomized trial conducted in France by a private practice/hospital network of general practitioners and hospital practitioners specializing in memory disorders. This study enrolled elderly subjects with spontaneous memory complaint and the primary outcome is the incidence of AD during a 5 years follow-up period. A total of 2854 subjects were enrolled between March 2002 and September 2004. The age of the study population was 76.8 +/- 4.4 with mean MMSE at entry 27.8 +/- 1.7. CONCLUSION: The GuidAge study is the largest study carried out in Europe on the prevention of AD. Final results should be available in 2010.

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PubMed2006

Mild cognitive impairment (MCI) in medical practice: a critical review of the concept and new diagnostic procedure. Report of the MCI Working Group of the European Consortium on Alzheimer's Disease.

Mild cognitive impairment (MCI) was proposed as a nosological entity referring to elderly people with mild cognitive deficit but no dementia. MCI is a heterogeneous clinical entity with multiple sources of heterogeneity. The concept of MCI was reviewed and a diagnostic procedure with three different stages was proposed by the European Consortium on Alzheimer's Disease Working Group on MCI. Firstly, MCI should correspond to cognitive complaints coming from the patients or their families; the reporting of a relative decline in cognitive functioning during the past year by a patient or informant; cognitive disorders as evidenced by clinical evaluation; absence of major repercussions on daily life; and absence of dementia. These criteria, similar to those defined during an international workshop in Stockholm, make it possible to identify an MCI syndrome, which is the first stage of the diagnostic procedure. Secondly, subtypes of MCI had to be recognised. Finally, the aetiopathogenic subtype could be identified. Identifying patients at a high risk for progression to dementia and establishing more specific and adapted therapeutic strategies at an early stage, together with more structured overall management, is made possible by the diagnostic procedure proposed.

Activities of Daily Living↗
PubMed2006

[Diagnosing malnutrition in the elderly].

The concept of malnutrition in the geriatric population describes a deficient state of energy and nutrient intake with harmful clinical consequences. Despite of having a significant effect on morbidity and mortality, there are no generally accepted criteria for diagnosing malnutrition in the elderly. With increasing age the general recognition of the nutritional status becomes more important for the diagnosis of malnutrition than isolated parameters. Recording a patient"s history must include any weight loss and changes in appetite. Reasons for a diminished nutritional intake must be explored systematically as well. As part of physical examination one has to pay attention to clinical signs of malnutrition (general muscular atrophy, loss of subcutaneous fat) and to signs of micronutrient deficiencies. The documentation of oral intake can supply important evidence for deficient intake of energy and nutrients. Of special relevance among anthropometric values are a BMI of less than 20 kg/m and calf circumference of less than 31 cm. Individual follow-up data are superior to isolated measurements Laboratory diagnostic tests (for example albumin) are of minor importance for the diagnosis of malnutrition because of their low specificity. As a consequence of unsolved methodical problems, bioelectrical impedance analysis can currently be recommended only to those who are experienced with this method and its limitations. Screening and assessment tools like Mini Nutritional Assessment (MNA) and Nutritional Risk Screening(NRS) are helpful for a quick and simple identification of malnourished patients and those who are at risk. The MNA is especially applicable for people who live independently and for cooperative residents of nursing homes. The NRS is a valuable alternative for hospital patients and those unable to cooperate. Screening for malnutrition should be routine practice in the elderly population, especially for those at high risk for it like in hospitals and in nursing homes.

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PubMed2005

[Consensus statement on severe dementia].

Under the auspices of the French Society of Gerontology and Geriatrics, a multidisciplinary group of experts, including geriatricians, neurologists, epidemiologists, psychiatrists, pharmacologists, and public health specialists developed consensus recommendations about care for patients with severe dementia. They defined 21 recommendations for general practitioners, long-term care physicians, and specialists, based on the knowledge currently available (2005). The aim of care at all stages is to mitigate the quality-of-life of patient, caregiver, and family insofar as possible, combining care and future planning until the end of life. Management, to take into account problems including nutritional status, behavior disorders, and ability (or inability) to perform activities of daily living, must be global, multidisciplinary, and coordinated and must optimize use of local medical and social resources. The group also stressed the importance of clinical research to improve knowledge of disease course and assess management strategies and recommended specific area for research.

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PubMed2005

[Consensus statement on severe dementia].

Under the auspices of the French Society of Gerontology and Geriatrics, a multidisciplinary team including geriatritians, neurologists, epidemiologists, psychiatrists, pharmacologists and public health specialists developed a consensus on care for patients with severe dementia. They defined 21 recommendations for general practitioners, long-term care physicians and specialists based on knowledge available in 2005. At all stages of the disease, the objective of care is to improve as much as possible quality-of-life for the patient and his/her family, including a life project until the end of life. It is always possible to do something for these patients and their family: nutritional status, behavior disorders, and incapacities to deal with basic activities of daily life have to be taken in consideration. Resource allocation and proximity care have to be targeted. Research areas necessary to improve the care of patients with severe dementia has been selected.

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PubMed2005

The practice of obtaining approval from medical research ethics committees: a comparison within 12 European countries for a descriptive study on acetylcholinesterase inhibitors in Alzheimer's dementia.

Across Europe the protection of research subjects with dementia has to meet a variety of national legislation and ethical codes. This research project compared how in different EU countries one single descriptive multinational study on dementia treatment strategies was evaluated by medical ethical committees and how the issues of informed consent and capacity to consent were dealt with. The study that was evaluated is the ICTUS study, which studies the impact of treatment with acetylcholinesterase inhibitors (AChE-I) on Europeans with mildly or moderately severe Alzheimer's disease (AD). Participating centres in all 12 countries that take part in the study received a questionnaire with items on the process of approval by the ethical committee and the informed consent procedure. From the 29 centres we received 21 completed questionnaires (response rate of 72%). There were great differences in valuation of the study, varying from the judgement that the ICTUS study was 'no experimental study' to the judgement that it was a phase IV drug trial. All centres got approval, after 3-90 days. Informed consent was addressed very differently by the researchers. There was no formal informed consent procedure required by the ethical committees. The data from this survey suggest that there should be more consensus across the EU about which studies or interventions do and which do not require approval of an ethics committee. Procedures for the assessment of informed consent in dementia research should be harmonized by central national or European bodies.

Alzheimer Disease↗
PubMed2005

Long-term cholinergic treatment is not associated with greater risk of weight loss during Alzheimer's disease: data from the French REAL.FR cohort.

BACKGROUND: An increased incidence of weight loss has been reported in patients with Alzheimer's disease (AD) treated with higher doses of acetylcholinesterase inhibitors (AChEI) compared with placebo patients in several clinical trials. The proportion of patients losing weight is extremely variable from one study to another and further analysis is necessary to reach a conclusion on the association of weight loss and AChEI. OBJECTIVE: This observational study was designed to investigate the potential effects of AChEI use on weight loss during AD. DESIGN: 486 patients with AD were followed for one year (initial mean age 77.3 +/- 77 years; initial mean MMS score 20.3 +/- 4.2). Comprehensive geriatric and neuropsychological assessment was conducted every 6 months. Cholinergic treatment was recorded at each visit, as well as any concomitant medication for dementia, psychotropic and other medications. We defined clinically significant weight loss as > or = 4% of the subject's initial weight based on the last measured weight. The data were initially evaluated categorically to identify those who had lost > or = 4% of their initial weight or had remained stable. RESULTS: Eighty-nine per cent of AD patients were treated with AchEI during the first year of follow-up. Twenty-one per cent experienced clinically significant weight loss during this period. Weight loss was associated with more rapid deterioration of cognitive function (Delta MMSE -2.62 +/- 3.99 versus -1.72 +/- 3.64, P = 0.014) and loss of independence in instrumental activities of daily living (Delta IADL -1.45 +/- 1.50 versus - 0.88 +/- 1.43, P = 0.002). The frequency of weight loss was similar whether AD patients were treated with AChEI or not (respectively 21.1 and 19.5%, P = 0.81). In multivariate analysis, the risk of weight loss was significantly decreased in patients taking AChEI for more than 3 months compared (OR = 0.25, 95% CI = 0.11-0.56, P = 0.0007). CONCLUSIONS: Our data suggest that long-term cholinergic treatment is not associated with greater risk of weight loss during AD and may be a protective factor. Further analysis is necessary to confirm this relation. It is obvious that the benefit observed might also be partly related to the organised non-pharmacological management provided for our patients, which included a specific care plan for each individual and facilitated response to nutritional problems as they occurred. Global care of AD patients must associate regular pluridisciplinary management with AChEI treatment.

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PubMed2005

Impact of nutritional status on the evolution of Alzheimer's disease and on response to acetylcholinesterase inhibitor treatment.

BACKGROUND: Weight loss is frequently observed in patients with Alzheimer's disease (AD), as observed in clinical practice and reported in the literature. However, information on the evolution of nutritional status and its impact on the prognosis of AD is still scarce. OBJECTIVE: Our aim was to determine the impact of nutritional status on the evolution of AD and on the response to treatment with acetylcholinesterase inhibitors (AChEI) by prospective one-year follow-up of AD patients living at home. METHODS: We studied a cohort of 523 patients with Alzheimer's disease referred from 1994 to 2002 to an Alzheimer centre. After diagnosis, they were followed for one year in a prospective observational study in clinical practice. At entry and every 6 months, patients underwent standardised neurocognitive and geriatric evaluation (MMSE, ADAS-cog, IADL, MNA, caregiver burden). These evaluations were accompanied by complete clinical examination, standard paraclinical investigations and recording of treatment received. RESULTS: Of our patients, 25.8% presented at inclusion a risk of undernutrition with an MNA score of 23.5 or less. During follow-up, the number of patients with rapid loss on the MMSE (3 points or more in one year) was higher in subjects who presented a risk of undernutrition at inclusion (53.6%) than in well-nourished subjects (43.2%) (P = 0.07). Similarly, increased dependence at one year was more frequent in subjects at risk of undernutrition at inclusion (57.7% versus 44.4%, P = 0.0219). The beneficial effect of AChEI treatment on cognitive function was not influenced by initial nutritional status; on the contrary, among the subjects at risk of undernutrition at inclusion, the risk of rapid loss on the MMSE in one year was decreased in subjects treated during follow-up compared with untreated subjects (43.9% versus 73.1% ; OR = 0.29; 95% CI = 0.10-0.83; P = 0.0219). This relationship was not found in subjects whose initial MNA score was greater than 23.5. CONCLUSION: Our work indicates that AD patients living at home with a caregiver are frequently at risk of undernutrition. Undernourished patients seem to present more rapid aggravation of the disease, but paradoxically, these patients appear to be those who best respond to AChEI treatment.

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PubMed2005

Nutritional status assessment during Alzheimer's disease: results after one year (the REAL French Study Group).

OBJECTIVES: Weight loss and malnutrition are frequent and serious complications of Alzheimer's disease. The aim of the present article was to describe the cognitive and behavioural characteristics of the test population within the frame of the PHRC REAL.FR cohort (for Réseau sur la Maladie d'Alzheimer Français), depending on their nutritional state, and to consider their evolution one year after the original inclusion. METHOD: The study population' stratification was done in three groups according to their Mini Nutritional Assessment (MNA) score: malnutrition group (MNA < 17.5), at risk of malnutrition group (MNA 17.5-23.5), and normal nutritional status group (MNA > or = 23.5). 561 patients were evaluated at inclusion time, 393 at one year. The evaluation included the following scales: Mini Nutritional Assessment (MNA), Mini Mental State Examination (MMSE), Activities Daily Living (ADL), Instrumental Activities Daily Living (IADL), Neuro Psychiatric Inventory (NPI) and Zarit scale (ZARIT). Comparison and descriptive analysis for each MNA group at baseline and at one year has been performed. RESULTS: at baseline, the well-nourished and the malnutrition risk groups are significantly different concerning age, IADL and NPI; the well-nourished and undernutrition groups are different concerning MMSE, NPI and Zarit; the malnutrition risk and undernutrition groups are only different concerning NPI. At one year, the well-nourished and the malnutrition risk and undernutrition groups are different concerning one lonely variable, the NPI, in a significant way. The comparison of the three groups between baseline and one-year evaluation demonstrate for the well-nourished group an aggravation of MMSE, ADL, IADL, NPI, for the malnutrition risk group of MMSE and IADL, and for the undernutrition group of MMSE, IADL and NPI. CONCLUSION: Among the patients suffering from Alzheimer's disease, the most malnutritioned worsen highly on cognitive and functional capacities. Furthermore, the nutritional aggravation seems strongly linked to behavioural disorders aggravation. The improvement of those disorders has therefore to be part of every improvement strategy applied to the nutritional status of the demented patients.

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PubMed2005

Recent data on the natural history of Alzheimer's disease: results from the REAL.FR Study.

OBJECTIVES: This paper aims to present the changes observed in the evolution of Alzheimer's disease (AD) in the cohort REAL.FR after one year by taking account new treatments and improved management. METHODS: Four hundred and ninety-eight patients recruited for the REAL.FR study were followed for one year with a standardized case report filled for each patient every 6 months. Changes in the status of these patients were evaluated on various levels: cognitive, functional, behavioural, global, nutritional, social, medical and caregiver burden. Specific treatments were also recorded. RESULTS: A high proportion of patients received specific treatment for AD throughout the year (86%), mainly acetylcholinesterase inhibitors (AChEI) . As expected we observed statistically significant changes in cognitive function (MMS: -1.93 +/- 3.74, p < 0.0001 and ADAS-cog: +2.40 +/- 3.74, p < 0.0001), an overall loss of autonomy (ADL: -0.56 +/- 1.05, p < 0.0001 and IADL: -1.00 +/- 1.46, p < 0.0001), worsening of behavioral disturbances (NPI: +1.85 +/- 14.83, p=0.0047) and a deterioration of general status (CDRSB: +1.63 +/- 2.55, p< 0.0001). Even if the MNA score decreased not significantly, the loss was close to the threshold of significativity (MNA: -0.31 +/- 3.07, p=0.0531). CONCLUSION: We observed a statistically significant change for the worse in most parameters. However, it appears that this deterioration had been relatively slowed by non-pharmacological management and the specific AD treatments. This resulted in stability or improvement of the condition in 63.4% of patient at 1 year. The management proposed (including prescription of AChEI) seemed to have a real impact on the course of the disease during this first year of follow-up.

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PubMed2005

One-year longitudinal evaluation of neuropsychiatric symptoms in Alzheimer's disease. The REAL.FR Study.

Behavioral and Psychological Symptoms are major and frequent manifestations of Alzheimer's Disease (AD). The aim of the present study was to evaluate neuropsychiatric symptoms in the PHRC REAL.FR cohort (for Réseau sur la maladie d'Alzheimer Français) after one year of evolution. Four hundred and eighty two patients with mild and moderate AD were assessed. A majority of them had significant symptoms at inclusion (85.3 % of subjects with mild AD, 89.7% of patients with a moderate AD). Patients with mild AD had a significant increase of the Neuropsychiatric Inventory (NPI) frequency x severity scores for apathy and aberrant motor behavior. Patients with moderate AD had a significant increase of NPI disinhibition, aberrant motor behavior and sleep disorders scores. The variation of NPI total score at one year correlated positively with change in Zarit's caregiver burden score, independently of global cognitive evolution. After one year, a group of 54 patients were institutionalized in nursing home or long term care unit. When compared to non institutionalized patients, the institutionalized group was characterized at base line by a lower MMSE score, a higher Zarit caregiver burden score, and a higher NPI agitation and disinhibition scores.

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PubMed2005

Predictive factors of rate of loss of autonomy in Alzheimer's disease patients. A prospective study of the REAL.FR Cohort.

Alzheimer's disease is characterised by a progressive loss of autonomy in activities of daily living. Many patients lose this autonomy rapidly with dramatic consequences for the patients and their relatives, and for health and social services. The aim of this study was to determine, in a large French cohort of community-living Alzheimer patients (REAL.FR), the factors underpinning different rates of loss of autonomy. Six hundred and eighty seven patients were recruited to this French cohort. Autonomy in activities of daily living was estimated with the IADL scale (Lawton). Patients were divided into three groups according to loss of autonomy during the first one-year follow-up period. Patients with a decrease in the IADL score had worse ADAS-cog score (Alzheimer's Disease Assessment Scale, cognitive subscale), Mini-Mental State Examination (MMSE), and Clinical Dementia Rating Scale scores. Up to a point, a marked decrease in the IADL score was less frequent among patients with a better ADAS-cog score (p < 0.10, bilateral test). At one-year evaluation, patients with a marked decline in autonomy were characterised by a greater decrease in Mini-Mental State score, faster progression of behavioural disturbance, and more hospitalisations. Further prospective studies, using established models, are needed to isolate the factors associated with a high rate of loss of autonomy in activities of daily living in Alzheimer patients.

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PubMed2005

Predictive factors of emergency hospitalisation in Alzheimer's patients: results of one-year follow-up in the REAL.FR Cohort.

OBJECTIVE: To determine the predictive factors of hospitalisation in patients with Alzheimer's disease followed in the REAL.FR cohort. METHODS: A French multicentre prospective study (REAL.FR) following 516 patients who had mild to moderate AD at inclusion. Analysis of the data after one year of follow-up. RESULTS: 139 (26,9%) of the 516 initial AD patients were hospitalized during the 1 year of follow-up. After bivariate analysis, the principal predictive factors of hospitalisation were high scores on the Reisberg scale (> or = 5: P = 0.0149) and the CDR (1: P = 0.0289; 2 or 3: P = 0.0078); > or = 2 intercurrent diseases (P = 0.00104); > or = 3 other treatments (not including specific treatments for AD) (P = 0.0026); BMI (kg/m2) between 25 and 30 (P = 0.0147); impossibility of single-leg stance (P = 0.02); > or = 1 disabilities on the ADL (P = 0.0009) and > or = 2 disabilities on the IADL (P = 0.0017); use of medical services (P = 0.0236) and of non-medical services (P = 0.0403); delirium or hallucinations (P = 0.0135), depression (P = 0.0014), or disinhibited behaviour (P = 0.0030); the gravity and frequency of behavioural symptoms (NPI freq x grav > or = 11 (median), P = 0.0012); and lastly, a score of > or = 20 for subjective caregiver burden on the Zarit scale (P < 0.0001). Multivariate analysis revealed an association between the risk of hospitalisation and the following variables : the type of centre to which the patient was admitted (neurological, psychiatric or geriatric), impaired orientation on the MMS, BMI, the number of disabilities on the ADL, and caregiver burden as evaluated by the Zarit scale. CONCLUSION: At inclusion, patients with more severe cognitive disorders, poor nutritional status and those who were the most dependent for basic activities of daily living were already at greater risk of hospitalisation. Exhaustion of the informal caregiver was an independent and supplementary predictive factor of hospitalisation.

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PubMed2005

Living alone with Alzheimer's disease: cross-sectional and longitudinal analysis in the REAL.FR Study.

OBJECTIVES: The purpose of this study was to examine the characteristics of Alzheimer's disease (AD) patients living alone and to describe the rate of cognitive and functional impairment after a one-year follow-up. DESIGN AND SETTING: In a prospective longitudinal study conducted by the French network on Alzheimer's disease (the REAL.FR study), 677 older community-dwelling AD patients were interviewed and completed questionnaires and evaluation scales every 6 months during a one-year follow-up. MEASUREMENTS: All patients were assessed by trained staff who collected data on neuropsychological status using the Mini Mental State Examination (MMSE), behavioural disturbances with the Neuropsychiatric Inventory (NPI) and nutritional status with the Mini Nutritional Assessment (MNA). Patients were assessed for current mobility and function in activities of daily living (ADL) and instrumental activities of daily living (IADL). RESULTS: At inclusion, 28% of the 677 non-institutionalised individuals with AD lived alone. Those who lived alone were significantly older than those who did not, and among them the percentage of women was significantly higher. Patients living alone were at increased risk of malnutrition and were more likely to have a low income than those living with others. Persons with AD living alone made greater use of health services. Dementia stage evaluated by cognitive impairment (MMSE) and ADL disabilities was similar in both groups. At one-year follow-up, the mortality rate was significantly higher in AD patients living with others. Institutionalisation and hospitalisation rates were similar. CONCLUSION: These results draw attention to the fact that elderly persons with AD living alone are a subpopulation with specific needs which require the development of targeted interventions. Further investigation of the factors associated with the lower mortality rate in AD patients living alone is necessary, and the results of long-term follow-up in this prospective study should shed light on this question.

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PubMed2005

Rapid cognitive decline: searching for a definition and predictive factors among elderly with Alzheimer's disease.

The pattern and rate of cognitive decline in AD patients is far from uniform. In clinical practice, certain patients present episodes of rapid cognitive loss, whereas others deteriorate more progressively. At present time, there is little known about rapid decline in cognitive function in patients with AD, and moreover among older population. The main objective of this review was to elaborate a proposal of definition of rapid cognitive decline in order to facilitate its applicability into ordinary medical practice and to be relevant for clinical-decision making in old patients with AD. After the literature review, our results from longitudinal prospective studies and our clinical practice experience, we propose the following definition of rapid cognitive decline: a four-point or greater loss on the MMSE within six months and the loss of at least one point on the MMSE during the following six months. After ELSA cohort's results, 11% of an AD population of 312 patients were rapid cognitive decliners, complying with our proposed definition. They represent a non-negligible proportion of the population afflicted by AD.

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PubMed2005

Predictive factors for rapid loss on the mini-mental state examination in Alzheimer's disease.

OBJECTIVES: To seek predictors of rapid loss of cognition and to evaluate their frequency in a prospective study of patients suffering from Alzheimer's disease (AD). DESIGN: A one-year prospective study. METHODS: 312 AD patients from the memory clinic at Toulouse University Hospital, participants in the ELSA study, were enrolled. Rapid cognitive decline was defined as a 4-point or greater loss on the Mini-Mental State Examination (MMSE) in 6 months. Comprehensive geriatric and neuropsychological assessment was conducted at baseline, 6 months and one year. RESULTS: Seventy-nine (24.8%) patients presented rapid cognitive loss over 6 months. The majority were stable at one year whereas 15 experienced continued rapid cognitive loss. Multivariate analysis showed that only the Mini Nutritional Assessment score (MNA) was correlated with rate of decline. Patients with rapid cognitive decline were also significantly more dependent at 6 months. CONCLUSIONS: Our findings demonstrate that rapid cognitive loss is frequent in AD patients, probably indicating underlying frailty. Future studies should lead to a practical approach to detecting these frail patients and to increasing preventive interventions.

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PubMed2004

Economic evaluation of donepezil in moderate to severe Alzheimer disease.

OBJECTIVE: To investigate the costs to society of Alzheimer disease (AD) care in a multinational, randomized, placebo-controlled trial of donepezil in patients with moderate to severe AD. METHODS: A total of 290 patients with AD (screening standardized Mini-Mental State Examination score 5 to 17) were randomized to receive either donepezil (n = 144; 5 mg/day for 28 days, followed by 10 mg/day as per clinician's judgment) or placebo (n = 146) for 24 weeks. The authors collected data on patient and caregiver health resource utilization prospectively using the Canadian Utilization of Services Tracking questionnaire. Costs were calculated for patients and caregivers in each group based on resource utilization multiplied by the unit prices for each resource. A cost (the average Ontario minimum wage for 1998 [Can 6.85 dollars per hour]) was assigned to unpaid time that caregivers spent assisting the patient with activities of daily living (ADL). RESULTS: Patient and caregiver demographics at baseline were similar across the two groups. After adjusting for baseline total cost per patient, the mean total societal cost per patient for the 24-week period was donepezil, Can 9,904 dollars (US 6,686 dollars) and placebo, Can 10,236 dollars (US 6,910 dollars). This net cost saving of Can 332 dollars (US 224 dollars) included the average 24-week cost of donepezil treatment. Most of the cost-saving with donepezil treatment was due to less use of residential care by patients, and caregivers spending less time assisting patients with ADL. CONCLUSION: This cost-consequence analysis reveals economic benefits of treatment of moderate to severe AD with donepezil.

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