Severe Impairment Battery Scores Research Articles

Donepezil preserves cognition and global function in patients with severe Alzheimer disease

To evaluate the efficacy and safety of donepezil for severe Alzheimer disease (AD). Patients with severe AD (Mini-Mental State Examination [MMSE] scores 1 to 12 and Functional Assessment Staging [FAST] scores > or =6) were enrolled in this multinational, double-blind, placebo-controlled trial at 98 sites. Patients were randomized to donepezil 10 mg daily or placebo for 24 weeks. Primary endpoints were the Severe Impairment Battery (SIB) and Clinician's Interview-Based Impression of Change-Plus caregiver input (CIBIC-Plus). Secondary endpoints included the MMSE, the Alzheimer Disease Cooperative Study-Activities of Daily Living-severe version (ADCS-ADL-sev), the Neuropsychiatric Inventory (NPI), the Caregiver Burden Questionnaire (CBQ), and the Resource Utilization for Severe Alzheimer Disease Patients (RUSP). Efficacy analyses were performed in the intent-to-treat (ITT) population using last post-baseline observation carried forward (LOCF). Safety assessments were performed for patients receiving > or =1 dose of donepezil or placebo. Patients were randomized to donepezil (n = 176) or placebo (n = 167). Donepezil was superior to placebo on SIB score change from baseline to endpoint (least squares mean difference 5.32; p = 0.0001). CIBIC-Plus and MMSE scores favored donepezil at endpoint (p = 0.0473 and p = 0.0267). Donepezil was not significantly different from placebo on the ADCS-ADL-sev, NPI, CBQ, or RUSP. Adverse events reported were consistent with the known cholinergic effects of donepezil and with the safety profile in patients with mild to moderate AD. Patients with severe AD demonstrated greater efficacy compared to placebo on measures of cognition and global function.

Cost-effectiveness of memantine in moderate-to-severe Alzheimer's disease patients receiving donepezil

ABSTRACTObjective: The efficacy and safety of memantine in patients with moderate-to-severe Alzheimer's disease (AD) receiving stable doses of donepezil were recently demonstrated in a phase III trial. The cost-effectiveness of such therapy is unknown.Research design and methods: A microsimulation model was developed to depict AD progression over time and associated clinical and economic outcomes. AD progression was measured in terms of decline in cognitive function, as assessed by the Severe Impairment Battery (SIB). At model entry, patients were assumed to have moderate-to-severe AD, to be on stable doses of donepezil, and to begin combination therapy with memantine, or continue to receive donepezil alone; duration of therapy was assumed to be 1 year. Drug efficacy was based on data from a phase III trial. Key assumptions of the model included: (1) efficacy of study drugs would extend to 1 year; (2) measures of cognitive function could be mapped to one another, as well as to global measures of disease severity; and (3) following therapy discontinuation, cognitive function would revert immediately to natural history levels. Cost-effectiveness was assessed in terms of cost (2005 US$) per quality-adjusted life-year (QALY) gained over a lifetime (3% discount rate).Results: SIB scores were estimated to improve by 3.3 over 1 year from therapy with memantine plus donepezil (vs. donepezil alone). While pharmacotherapy costs were estimated to increase by $1250 during the year of memantine treatment, costs of formal and informal services were estimated to decrease by $1240 over this period and by $1493 (discounted present value) over a lifetime. Findings were sensitive to the assumed SIB score at therapy initiation; cost-effectiveness was better for patients with higher initial SIB scores (i.e., less severe disease).Conclusion: In patients with moderate-to-severe AD already receiving donepezil, treatment with memantine results in improved clinical outcomes and reduced total costs of care.

Donepezil in patients with severe Alzheimer's disease: double-blind, parallel-group, placebo-controlled study

The cholinesterase inhibitor donepezil is used to treat mild-to-moderate Alzheimer's disease. Its efficacy in severe dementia has not been assessed and is controversial. Our aim was to ascertain the effectiveness of donepezil in patients with severe Alzheimer's disease, by focusing primarily on cognition and activities of daily living. We did a 6-month, double-blind, parallel-group, placebo-controlled study in 248 patients with severe Alzheimer's disease (mini mental state examination score 1-10) who were living in assisted care nursing homes ran by trained staff in Sweden. We assigned patients oral donepezil (5 mg per day for 30 days then up to 10 mg per day thereafter, n=128) or matched placebo (n=120). Our primary endpoints were change from baseline to month 6 in the severe impairment battery (SIB) and modified Alzheimer's Disease Cooperative Study activities of daily living inventory for severe Alzheimer's disease (ADCS-ADL-severe). We analysed outcomes for patients with data at baseline and at one or more other timepoints (modified intent-to-treat population) with last observation carried forward used to replace missing data. 95 patients assigned donepezil and 99 patients assigned placebo completed the study. Patients treated with donepezil improved more in SIB scores and declined less in ADCS-ADL-severe scores at 6 months after initiation of treatment compared with baseline than did controls (least squares [LS] mean difference, 5.7, 95% CI 1.5-9.8; p=0.008, and 1.7, 0.2-3.2; p=0.03, respectively). The incidence of adverse events was comparable between groups (donepezil 82% [n=105] vs placebo 76% [n=91]), with most being transient and mild or moderate in severity. More patients discontinued treatment because of adverse events in the donepezil group (n=20) than in the placebo group (n=8). Donepezil improves cognition and preserves function in individuals with severe Alzheimer's disease who live in nursing homes.

Reliability and Validity of the Severe Impairment Battery (SIB) in Korean Dementia Patients

This study was conducted to examine the reliability, validity and clinical utility of the Severe Impairment Battery (SIB) for a Korean population. 69 dementia patients with Clinical Dementia Rating (CDR) stages 2 or 3 were participated in this study. The SIB, Korean version-Mini Mental State Examination (K-MMSE), CDR, and Seoul-Activities of Daily Living (S-ADL) were administered. The validity of the SIB was confirmed by evaluating the correlation coefficients between the SIB and K-MMSE, CDR, S-ADL, which were found to be significant. Cronbach's alpha for the total SIB score and each subscale score showed high significance, and the item-total correlation for each subscale was also acceptable. The test-retest correlation for the total SIB score and subscale scores were significant, except for the praxis and orienting to name. The total SIB score and subscale scores were examined according to CDR. The results suggest that the SIB can differentiate the poor performances of severely impaired dementia patients. On the basis of the receiver operating characteristic (ROC), it can be concluded that the SIB is able to accurately discriminate between CDR 2 and 3 patients. The results of this study suggest that the SIB is a reliable and valid instrument for evaluating severe dementia patients in Korean population.

Development of a Short Form of the Severe Impairment Battery

The authors sought to develop a short form of the Severe Impairment Battery (SIB). Authors describe the development of an empirically-derived short form of the SIB (SIB-S) by use of data from 191 subjects with severe dementia in the United States and France. Mean (standard deviation) Mini-Mental State Exam scores for the American and French samples were 7.7 (4.8) and 5.7 (3.4), respectively, and original SIB scores were 71.87 (18.34) and 58.38 (26.86), respectively. Exploratory factor analyses were conducted separately and in combination for the two samples, to determine the number of clinically meaningful factors. An eight-factor model, explaining 60.2% of the common variance, was selected. The eight constructs were described as: expressive language, memory (verbal and nonverbal), social interaction, color-naming, praxis, reading and writing, fluency, and attention. Derived SIB-S scores were 38.41 (9.12) and 29.79 (13.17) for the American and French samples, respectively. The original SIB is a valid and reliable research tool developed to enable reliable assessment of patients with severe dementia; it takes approximately 30 minutes to administer. The SIB-S takes only 10-15 minutes to administer, making it more appropriate for use in patients with very severe dementia, while it maintains the attributes of the original SIB.

Development of a Short Form of the Severe Impairment Battery

Objective The authors sought to develop a short form of the Severe Impairment Battery (SIB). Methods Authors describe the development of an empirically-derived short form of the SIB (SIB–S) by use of data from 191 subjects with severe dementia in the United States and France. Results Mean (standard deviation) Mini-Mental State Exam scores for the American and French samples were 7.7 (4.8) and 5.7 (3.4), respectively, and original SIB scores were 71.87 (18.34) and 58.38 (26.86), respectively. Exploratory factor analyses were conducted separately and in combination for the two samples, to determine the number of clinically meaningful factors. An eight-factor model, explaining 60.2% of the common variance, was selected. The eight constructs were described as: expressive language, memory (verbal and nonverbal), social interaction, color-naming, praxis, reading and writing, fluency, and attention. Derived SIB–S scores were 38.41 (9.12) and 29.79 (13.17) for the American and French samples, respectively. Conclusions The original SIB is a valid and reliable research tool developed to enable reliable assessment of patients with severe dementia; it takes approximately 30 minutes to administer. The SIB–S takes only 10–15 minutes to administer, making it more appropriate for use in patients with very severe dementia, while it maintains the attributes of the original SIB. The authors sought to develop a short form of the Severe Impairment Battery (SIB). Authors describe the development of an empirically-derived short form of the SIB (SIB–S) by use of data from 191 subjects with severe dementia in the United States and France. Mean (standard deviation) Mini-Mental State Exam scores for the American and French samples were 7.7 (4.8) and 5.7 (3.4), respectively, and original SIB scores were 71.87 (18.34) and 58.38 (26.86), respectively. Exploratory factor analyses were conducted separately and in combination for the two samples, to determine the number of clinically meaningful factors. An eight-factor model, explaining 60.2% of the common variance, was selected. The eight constructs were described as: expressive language, memory (verbal and nonverbal), social interaction, color-naming, praxis, reading and writing, fluency, and attention. Derived SIB–S scores were 38.41 (9.12) and 29.79 (13.17) for the American and French samples, respectively. The original SIB is a valid and reliable research tool developed to enable reliable assessment of patients with severe dementia; it takes approximately 30 minutes to administer. The SIB–S takes only 10–15 minutes to administer, making it more appropriate for use in patients with very severe dementia, while it maintains the attributes of the original SIB.

Quetiapine and rivastigmine and cognitive decline in Alzheimer's disease: randomised double blind placebo controlled trial

Objectives To determine the respective efficacy of quetiapine and rivastigmine for agitation in people with dementia in institutional care and to evaluate these treatments with respect to change in cognitive...

An Examination of the Severe Impairment Battery as a Measure of Cognitive Decline in Clients with Down's Syndrome

The present study examined the validity of the Severe Impairment Battery (SIB) as a tool for measuring cognitive decline in clients with Down's syndrome. Two groups participated: 10 clients who showed behavioural decline over at least a 2 year period as measured by the Vineland Adaptive Behaviour Scales, and 14 clients who showed no decline on this measure over the same period. No differences were found between the two groups in relation to health or life factors which may have impacted on functional and cognitive decline. The deteriorating group were found to be significantly older than the non-deteriorating group. The comparison of the SIB scores indicated that the deteriorating group showed a significant decline between baseline and 12 months and baseline and 24 months on the orientation factor. By contrast, for the non-deteriorating group, significant increases were found for praxis, orientating to name and total scores.

Neuropsychological assessment of the severely impaired elderly patient: validation of the Italian short version of the Severe Impairment Battery (SIB). Gruppo di Studio sull'Invecchiamento Cerebrale della Società Italiana di Gerontologia e Geriatria.

One hundred and sixty-nine severely demented patients were tested in a multicenter study with the short version of the Severe Impairment Battery which was translated into Italian with the purpose of adapting and validating it for an Italian population. Patients were enrolled in Italian geriatric centers participating in the Study Group on Aging Brain of the Italian Society of Gerontology and Geriatrics. Following thorough clinical and instrumental examinations, they were evaluated with the Mini Mental State Examination, the Clinical Dementia Rating, the Severe Impairment Battery (SIB), the Gottfries-Bråne-Steen Rating Scale for Dementia, the Activity of Daily Living index, and the Bedford Alzheimer Nursing Severity scale (BANS.s). The inter-rater reliability of the SIB was highly significant for the total score and its subtests; test-retest reliability showed the same significance in all items. Also concurrent validity, performed comparing the total SIB score with the total BANS.s score, was significant. The short Italian version of the SIB proved to be a very reliable tool for the evaluation of severely demented patients; it has the advantage of being easy to administer, it evaluates more cognitive domains that, are typically assessed in dementia, and has a wide enough range of scores to detect even small differences in the examined abilities.

Severe impairment battery. A neuropsychological test for severely demented patients.

Patients with progressive dementia invariably evolve to a stage where they can no longer be tested by standard neuropsychological tests. We studied the use of the Severe Impairment Battery (SIB) in such patients. Case series. Geriatric long-term facility. Sixty-nine patients who met the criteria of the Diagnostic and Statistical Manual for Mental Disorders, Revised Third Edition, for dementia were selected. The diagnosis of probable Alzheimer's disease was established according to the guidelines suggested by the National Institute of Neurologic and Communicative Diseases and Stroke/Alzheimer's Disease and Related Disorders Association. There were 18 men and 51 women. The mean age of the population was 82.99 +/- 5.66 years. The mean Mini-Mental State Examination (MMSE) score was 10.71 +/- 6.14. To characterize the cognitive profile and evolution of severely demented patients by means of the SIB. The mean score on the SIB was 92.52 +/- 31.92, with a possible maximum of 133 points. Subgroups of patients with the most severe degree of dementia (MMSE scores of 0 to 5 and 6 to 11) showed significant differences in their scores on the SIB. In contrast, no differences were found between subgroups with MMSE scores of 6 to 11, 12 to 17, and greater than 17. Fifteen patients who had MMSE scores of less than 6 had SIB scores ranging from 7 to 81. All cognitive domains showed a deterioration across the four severity groups as determined by the MMSE scores and also during a longitudinal study performed on 26 patients. Our study indicates that the SIB is useful for the neuropsychological evaluation of severely demented patients and for their follow-up.