Nimodipine in Subcortical Vascular Dementia Trial

Rossi, Ruggero; Inzitari, Domenico; Pantoni, Leonardo; Ser, Teodoro del; Erkinjuntti, Timo; Wallin, Anders; Bianchi, Cosetta; Badenas, Josep M.; Beneke, Manfred

doi:10.1097/00002093-199912001-00022

Cited by 3 publications

(4 citation statements)

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“…9 The appraisal of WMCs represents an important step in the evaluation of patients affected by dementia or cerebrovascular diseases and in the field of age-related brain abnormalities. More recently, WMC severity has also been incorporated as part of the inclusion criteria of therapeutic trials focused on vascular dementia, [23][24][25][26] and WMC load has been proposed as an outcome measure. 9 Therefore, it appears essential that the methods for the evaluation of WMCs be as accurate and reproducible as possible.…”

Section: Discussionmentioning

confidence: 99%

Visual Rating Scales for Age-Related White Matter Changes (Leukoaraiosis)

Pantoni

Simoni

Pracucci

et al. 2002

Stroke

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Background and Purpose-It has been hypothesized that the use of different visual rating scales partly explains the discordant results of studies investigating risk factors and clinical correlates of age-related cerebral white matter changes (leukoaraiosis). We aimed to compare 6 widely used rating scales for leukoaraiosis and to calculate conversion coefficients of the score of 1 scale in the score of a second scale. Methods-Two trained raters evaluated 80 pairs of CT and MRI scans using 2 CT and 4 MRI rating scales for white matter changes. Correlations among the scales were evaluated and regression lines were constructed with each of the CT and MRI scale scores as variables. Results-A high correlation was observed in all the paired comparisons of the 6 scales (Spearman's ranging from 0.85 to 0.96, PϽ0.0001). Using regression analysis, we determined numeric parameters to transform the score of 1 scale to the corresponding score for each of the remaining scales and relative confidence intervals. The predictive values of these conversions expressed as R 2 ranged from 0.75 to 0.92. Conclusions-The present findings support the view that a good correlation exists among the considered visual rating scales for white matter changes. With the limitation that conversion parameters are calculated by applying a linear regression to partly nonlinear scales, their use allows comparison of the results of previous studies that used different scales and to pool data from past and ongoing clinical trials.

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Section: Discussionmentioning

confidence: 99%

Visual Rating Scales for Age-Related White Matter Changes (Leukoaraiosis)

Pantoni

Simoni

Pracucci

et al. 2002

Stroke

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“…4,7 Considering the difference between groups by SCAGϭ5 points, standard deviationϭ11 points, an overall level of 5% for a 2-sided test with a 90% power (1-␤), the required minimum number of valid patients was 100 per treatment group. Given an expected dropout of 20%, the total number of patients to be randomized was increased to 240.…”

Section: Statistical Analysesmentioning

confidence: 99%

“…2,3 The dihydropyridinic calcium antagonist nimodipine has been proposed as a drug able to improve cognition in VaD because of vasoactive and neuroprotective actions. 4 Its effect on age-related microangiopathy in experimental models 5 makes nimodipine of potential interest for the treatment of small-vessel VaD subtypes. After the results of an openlabel study 6 and a post-hoc analysis of a randomized trial, 7 both showing some beneficial effects of nimodipine in patients with subcortical VaD features, an ad hoc designed trial was conducted to further test the efficacy and safety of oral nimodipine in subcortical VaD.…”

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confidence: 99%

Efficacy and Safety of Nimodipine in Subcortical Vascular Dementia

Pantoni

Ser²,

Soglian³

et al. 2005

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Background and Purpose-Evidence of drug efficacy in vascular dementia (VaD) is scanty. Therapeutic trials should address VaD subtypes. We studied the efficacy and safety of the calcium antagonist nimodipine in subcortical VaD. Methods-242 patients defined as affected by subcortical VaD based on clinical (ICD-10) and computed tomography criteria were randomized to oral nimodipine 90 mg/d or placebo. Results-230 patients (121 nimodipine, mean age 75.2Ϯ6.1; 109 placebo, 75.4Ϯ6.0) were valid for the intention-to-treat analysis. At 52 weeks, the Sandoz Clinical Assessment Geriatric scale 5-point variation (primary outcome measure) did not differ significantly between the 2 groups. However, patients on nimodipine performed better than placebo patients in lexical production (PϽ0.01) and less frequently showed deterioration (3 or more point-drop versus baseline) on a Mini-Mental State Examination (28.1% versus 50.5%; 2 PϽ0.01) and Global Deterioration Scale (PϽ0.05). Dropouts and adverse events were all significantly more common among placebo than nimodipine patients, particularly cardiovascular (30 versus 13; RR, 2.26; 95% CI, 1.11 to 4.60) and cerebrovascular events (28 versus 10; RR, 2.48; 95% CI, 1.23 to 4.98), and behavioral disturbances requiring intervention (22 versus 5; RR, 3.88; 95% CI, 1.49 to 10.12). A worst-rank analysis, performed to correct for the effect of the high dropout rate in the placebo group, showed additional significant differences in favor of nimodipine in Set Test and MMSE total scores. Conclusions-Nimodipine may be of some benefit in subcortical VaD. Confirming previous results, the safety analysis of this study shows that in this high-risk population, nimodipine might protect against cardiovascular comorbidities.

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“…Moreover, controlled clinical trials with donepezil, galantamine and rivastigmine in vascular dementia, as well as in patients with Alzheimer’s disease plus cerebrovascular dementia, have demonstrated improvement in cognition, behavior and activities of daily living 6 . The dihydropyridinic calcium antagonist nimodipine has been proposed as a drug able to improve cognition in vascular dementia because of its vasoactive and neuroprotective actions 7 . Indeed, a randomized placebo‐control trial demonstrated the efficacy and safety of nimodipine in subcortical vascular dementia 8 .…”

Section: Introductionmentioning

confidence: 99%

Gene therapy for ischemic brain disease with special reference to vascular dementia

Sato

Shimamura

Takeuchi

et al. 2007

Geriatrics Gerontology Int

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Vascular dementia is the second largest cause of dementia in the elderly. There is no effective treatment for cerebral infarction, which is one of the common causes of vascular dementia. In rodent experimental models, gene therapies using growth factors such as brain‐derived neurotrophic factor, fibroblast growth factor‐2, hepatocyte growth factor, glial cell‐line derived neurotrophic factor or vascular endothelial growth factor had beneficial effects on neuroprotection, neurogenesis and/or angiogenesis. Thus, gene therapies can be expected to be useful as new treatments for ischemic diseases, especially for vascular dementia. In clinical trials, gene therapy for vascular dementia still has some problems to be solved, such as the safety and effectiveness of vectors and delivery systems, the timing of treatment, and cell‐specific targeting strategies. The most important thing might be the definition of the best combination of these subjects for every target disease.

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Nimodipine in Subcortical Vascular Dementia Trial

Cited by 3 publications

References 0 publications

Visual Rating Scales for Age-Related White Matter Changes (Leukoaraiosis)

Visual Rating Scales for Age-Related White Matter Changes (Leukoaraiosis)

Efficacy and Safety of Nimodipine in Subcortical Vascular Dementia

Gene therapy for ischemic brain disease with special reference to vascular dementia

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