Cerebrolysin Improves Cognition and Clinical Functioning in Patients With Moderate to Moderate/Severe Vascular Dementia: Presented at ADPD

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By Chris Berrie

PRAGUE, Czech Republic -- Cerebrolysin is safe and improves both cognition and clinical functioning in patients with moderate to moderate/severe vascular dementia, according to trial data presented here at the 9th International Conference on Alzheimer's and Parkinson's Diseases (ADPD).

Previous clinical studies have shown that cerebrolysin can have positive clinical effects on patients with Alzheimer's disease and vascular dementia.

"We performed this trial because we had some very promising results from preliminary data, and so we moved to a bigger trial with more patients in vascular dementia," stated Edith Doppler, PhD, Research and Development, EBEWE Pharma, Unterach, Austria, presenting the prospective study here on March 14.

The aim was thus to determine the clinical outcome and safety of cerebrolysin treatment as an add-on to standard treatment with acetylsalicylic acid, as compared to placebo.

Subjects included in this multicentre, randomised, double-blind, placebo-controlled trial were aged 50 to 85 years with a confirmed diagnosis of vascular dementia, baseline Mini-Mental State Examination (MMSE) scores between 10 to 24, modified Hachinski Ischaemic score over 4, and Hamilton Depression Rating Scale scores of 15 or less. All women were postmenopausal. Standard exclusion criteria were applied.

Baseline was defined as 6 months of acetylsalicylic acid 100 mg treatment, when the 232 intention-to-treat patients with vascular dementia were randomised to receive add-on placebo (n = 115) or intravenous cerebrolysin 20 mL daily (n = 117) as two 1-month treatment cycles over 6 months, followed by 2-month treatment-free intervals.

The baseline clinical characteristics of the placebo and cerebrolysin groups were similar, including probable vascular dementia (73.9% vs 68.4%, respectively) and possible vascular dementia (26.1% vs 31.6%). Baseline scores on the modified Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog) were also similar (30.2 vs 29.5, respectively), as were the scores on the MMSE (19.4 vs 19.8), the Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL) subscale (52.5 vs 52.4), clock-drawing scores (6.2 vs 6.5); and trail-making scores (160.0 vs 149.9).

With the primary endpoints as changes from baseline, cerebrolysin treatment was significantly more beneficial than placebo at all assessments through to completion at 6 months on the ADAS-cog, (-10.6 vs -4.5; P < .0001 for all). On the Clinician's Interview Based Impression of Change plus caregiver input (CIBIC+), at completion, about 75% of the cerebrolysin group showed clinical improvements, with only about 35% seen for placebo.

The odds ratios for achieving a favourable response (ADAS-cog >4 points; CIBIC+ <4 points, from baseline) were........read the whole article

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