Nimodipine in the Treatment of Probable Alzheimerʼs Disease

Morich, F.; Bieber, Florian; Lewis, Jeanne M.; Kaiser, Lee; Cutler, Neal R.; Escobar, Javier I.; Willmer, J.; Petersen, Ronald C.; Reisberg, Barry

doi:10.2165/00044011-199611040-00001

Cited by 58 publications

(27 citation statements)

References 26 publications

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“…It is, however, surprisingly under-applied in treatment trials either as inclusion criterion or for stratification [39]. The outcomes of the current analysis provide supportive evidence for its use.…”

Section: Discussionmentioning

confidence: 52%

Influence of the Severity of Cognitive Impairment on the Effect of the Ginkgo biloba Extract EGb 761® in Alzheimer’s Disease

Velasco²,

et al. 2002

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Objective: To explore the treatment effect of EGb 761^® (EGb) in Alzheimer’s disease depending on baseline severity. Methods: We applied stratification to the intent-to-treat data set collected during a 52-week, randomized, double-blind, placebo-controlled, parallel-group, multicenter study with 120 mg of EGb, using cutoff points of 23 and 14 for the Mini-Mental State Examination (MMSE) score. Outcome measures used were the cognitive subscale of the Alzheimer’s Disease Assessment Scale (ADAS-Cog) and the Geriatric Evaluation by Relative’s Rating Instrument (GERRI). Results: In the severity stratum 1 (MMSE >23), the placebo group did not show significant changes, while the EGb group improved significantly by 1.7 points on the ADAS-Cog and by 0.09 points on the GERRI. In the severity stratum 2 (MMSE <24), the placebo group worsened by 4.1 points on the ADAS-Cog and 0.18 points on the GERRI, whereas the EGb group showed 60% less decline on the ADAS-Cog (treatment difference of 2.5 points) and no change on the GERRI (treatment difference of 0.25 points). The most severely impaired subgroup (MMSE <15) showed slightly more pronounced worsening for both treatment groups. However, in comparison to placebo, EGb induced virtually the same magnitude of effect as was observed in the entire stratum 2. Conclusions: The results of this retrospective analysis indicated that a treatment effect favorable to EGb could be observed with respect to cognitive performance (p = 0.02) and social functioning (p = 0.001) regardless of the stage of dementia, whether mild or moderately severe. However, the relative changes from baseline measured at endpoint depended heavily on the severity at baseline. Improvement was observed in the group of patients with very mild to mild cognitive impairment, while in more severe dementia, the mean EGb effect should be considered more in terms of stabilization or slowing down of worsening, as compared to the greater deterioration observed with placebo.

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Section: Discussionmentioning

confidence: 52%

Influence of the Severity of Cognitive Impairment on the Effect of the Ginkgo biloba Extract EGb 761® in Alzheimer’s Disease

Velasco²,

et al. 2002

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“…The results compare even more favorably when the changes occurring in the placebo groups are used to weigh the relative changes induced by 6 months active treatment, i.e. 'deterioration differential' [22]. While the group of AD patients receiving 160 mg tacrine worsened by 0.5 ADASCog points at endpoint, its placebo counterpart declined by 2.5 points, leading to a treatment difference of 2 points, representing an 80% magnitude of the changes observed in the placebo group [(2.5-0.5) !…”

Section: Discussionmentioning

confidence: 95%

A 26-Week Analysis of a Double-Blind, Placebo-Controlled Trial of the Ginkgo biloba Extract EGb 761® in Dementia

Bars

Kieser²,

Z³

2000

Dement Geriatr Cogn Disord

159

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This intent-to-treat (ITT) analysis was performed to provide a realistic image of the efficacy that could be expected after 26 weeks treatment with a 120-mg dose (40 mg t.i.d.) of EGb 761^® (EGb). The data were collected during a 52-week, double-blind, placebo-controlled, fixed dose, parallel-group, multicenter study. Patients were mildly to severely impaired and diagnosed with uncomplicated Alzheimer’s disease or multi-infarct dementia according to ICD-10 and DSM-III-R criteria. The primary outcome measures included the Alzheimer’s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog), Geriatric Evaluation by Relative’s Rating Instrument (GERRI) and Clinical Global Impression of Change. From 309 patients included in the ITT analysis, 244 patients (76% for placebo and 73% for EGb) actually reached the 26th week visit. In comparison to the baseline values, the placebo group showed a statistically significant worsening in all domains of assessment, while the group receiving EGb was considered slightly improved on the cognitive assessment and the daily living and social behavior. Mean treatment differences favored EGb with 1.3 and 0.12 points, respectively, on the ADAS-Cog (p = 0.04) and the GERRI (p = 0.007). In the group receiving EGb, 26% of the patients achieved at least a 4-point improvement on the ADAS-Cog, compared to 17% with placebo (p = 0.04). On the GERRI, 30% of the EGb group improved and 17% worsened, while the placebo group showed an opposite trend with 37% of patients worsening for 25% improved (p = 0.006). Regarding safety, no differences between EGb and placebo were observed.

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“…An additional (or alternative) still speculative explanation, could involve specific neuroprotection conferred by calcium-channel blockade. 155,156 The potential importance of the Syst-Eur results in terms of public health policies warrant confirmation by other trials. The SCOPE trial based on the angiotensin II receptor blocker candesartan is underway 157 and the OPERA study using the vasopeptidase inhibitor, omapatrilat, is just starting.…”

Section: Prevention Of Dementia and Antihypertensive Treatmentmentioning

confidence: 96%

Cerebral complications of hypertension

Rigaud

Staessen

et al. 2000

J Hum Hypertens

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Ischaemic and degenerative brain diseases are a major health problem leading to a devastating loss of autonomy. Hypertension has been shown to carry an increased risk not only for cerebrovascular morbidity and mortality but also for cognitive impairment and dementia. Although diastolic blood pressure is considered an important risk factor, it is now clear that isolated systolic hypertension and elevated pulse pressure also play an important role in the development of brain complications. Therefore the treatment of these conditions must urgently become a widespread tool of prevention. All the randomised placebo-controlled trials completed for the last 30 years have shown a reduction in fatal and/or non-fatal strokes. In the most recent trials in isolated systolic hypertension in older patients, the benefit was even greater because of the higher risk in these populations. The new classes of drugs, in particular, calcium-channels blockers and angiotensin-

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Nimodipine in the Treatment of Probable Alzheimerʼs Disease

Cited by 58 publications

References 26 publications

Influence of the Severity of Cognitive Impairment on the Effect of the <i>Ginkgo biloba</i> Extract EGb 761<sup>®</sup> in Alzheimer’s Disease

Influence of the Severity of Cognitive Impairment on the Effect of the <i>Ginkgo biloba</i> Extract EGb 761<sup>®</sup> in Alzheimer’s Disease

A 26-Week Analysis of a Double-Blind, Placebo-Controlled Trial of the Ginkgo biloba Extract EGb 761<sup>®</sup> in Dementia

Cerebral complications of hypertension

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