Age at Onset and Rate of Progression of Alzheimer's Disease

A 6-month double-blind, randomized, placebo-controlled clinical trial preceded by a 3-week single-blind, washout/run-in placebo phase was performed in male and female patients, 55–85 years of age with a clinical diagnosis of mild to moderate multi-infarct dementia according to DSM-III to evaluate the therapeutic efficacy and safety of nicergoline 30 mg b.i.d. Primary endpoints for efficacy were the changes in the Sandoz Clinical Assessment Geriatric Scale (SCAG) and Mini-Mental State Examination (MMSE) scores at the end of the treatment with respect to baseline. Secondary endpoints were Clinical Global Impression, 3 subtests of the Wechsler Adult Intelligence Scale and Blessed A scale for activities of daily living, and all endpoints in 2-month intervals. A total of 252 patients were screened, 136 patients entered the double-blind phase and were evaluated as intent-to-treat (ITT) patients. Fifteen patients were excluded from the efficacy analyses of valid cases (VC) due to protocol violations or because they dropped out of the study prematurely. Confirmatory efficacy analysis after 6 months of treatment revealed superiority of nicergoline treatment with p > 0.01 for both SCAG and MMSE scores (ITT and VC). Subsequent descriptive efficacy analysis resulted in significant differences in favor of nicergoline, in the majority of cases as early as 2 months after start of treatment. Nicergoline was well tolerated and a similar number of adverse events were observed in both the placebo and the nicergoline group.

Section: Discussionmentioning

confidence: 50%

A Multicenter Randomized Double-Blind Study on the Efficacy and Safety of Nicergoline in Patients with Multi-lnfarct Dementia

Herrmann

Stephan

Gaede

et al. 1996

“…32], Some studies reported that early onset of dementia or being old er were related to higher mortality [35. 36], although some studies have failed to replicate these findings [37,38]. Other studies conclude that performance on memory and language assessment task are predictors of mortality [15,16,39], Recent data showed that severity of dementia, rate of deterioration and caregiver's psychological status significantly influence death [12], Our prospective study confirms that measures of the severity of dementia (MMSE score, lost functions on ADL and IADL scales and aphasia) are predictors of death in AD patients; the other assessed variables, and in particu lar age, duration of dementia, comorbidity, behavior dis turbances, institutionalization and caregivers' character istics do not predict mortality.…”

mentioning

confidence: 75%

Predictors of Mortality and Institutionalization in Alzheimer Disease Patients 1 Year after Discharge from an Alzheimer Dementia Unit

Bianchetti

Scuratti

Zanetti

et al. 1995

Several factors have been reported to predict death and institutionalization in demented patients, even if the results of the studies are often conflicting. We conducted a study on a group of 86 consecutive noninstitutionalized probable Alzheimer disease (AD) patients, to evaluate clinical and social factors predicting mortality and institutionalization 1 year after discharge from the Alzheimer Dementia Unit at ''Sacro Cuore Fatebenefratelli’ Hospital, Brescia, Italy. The 1-year mortality rate was 13.9% and the 1-year rate of admission to a nursing home was 34%. Our data indicate that the number of lost functions on the Activity of Daily Living scale is the most important predictor of short-term mortality, independently of the degree of cognitive impairment, the duration of the dementia, the age of the patients and the number of chronic diseases. Our data also demonstrate that, in a short period of observation, behavioral disturbances (and in particular insomnia) and availability of social Services play a major role in the decision to institutionalize AD patients.

“…Several such tests have been designed specifically to quantify dementia severity with reference to specific cognitive symptoms associated with a diagnosis or progression of AD [31][32][33]. These assess ments applied to AD severity have been compared and shown to reflect similar aspects of cognitive ability dimen sions [5,34], However, when these tests have been evalu ated longitudinally, most studies have emphasized the variability of progression in individual AD patients [8,9,14,19,22,[35][36][37][38][39][40][41] and hence the heterogeneity of AD [42], There have been several efforts to standardize mea sures of dementia severity by geographic location, educa tional level [43][44][45][46], sex [47], and other demographic cross-sections [48][49][50], but without an absolute reference. There is, therefore, a clear need to develop improved stan dards by which patients with conservative diagnoses of AD [51 ] may be assessed more precisely for the severity of their dementia over the broad range of the disease.…”

Section: Introductionmentioning

confidence: 99%

Temporal Quantification of Alzheimer's Disease Severity: 'Time Index' Model

Ashford

Shan

Butler

et al. 1995

A fundamental issue in the clinical and neuropathological assessment of Alzheimer''s disease patients is quantification of dementia severity progression. Several methods have been advanced for the purpose of staging dementia with various sensitivities at different phases of the disease, but no mathematical function has been developed to link these measures to a physical continuum. Using a dynamic method for quantifying illness severity, change in severity over time was referenced to a cumulative temporal index, a physical dimension. Data from 33 patients with probable Alzheimer''s disease with at least 2 successive assessments on three 50-point scales measuring cognitive, behavioral, and daily living skills were used to determine rate of change. ''Fuzzy-logic'' smoothing of the data, integration over time, and least-squares regression were used to derive a cubic polynomial function to calculate a severity measure in which ''days of illness'' was estimated from the severity score. This method can be used to improve the comparability of performance across various mental status tests, and to link measures of very early phases of preclinical dementia and late profound dementia phases. This method also provides a description of an ''average'' time course for any population from which the index is derived.