Abstract
Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimers disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinicians Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: - 2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.
Keywords: Alzheimer's disease, randomized controlled trial, cerebrolysin, combination therapy, neurotrophic factor, donepezil, cholinesterase inhibitors, trophic factor, ApoE genotyping
Current Alzheimer Research
Title: Combination Treatment in Alzheimers Disease: Results of a Randomized, Controlled Trial with Cerebrolysin and Donepezil
Volume: 8 Issue: 5
Author(s): X. A. Alvarez, R. Cacabelos, C. Sampedro, V. Couceiro, M. Aleixandre, M. Vargas, C. Linares, E. Granizo, M. Garcia-Fantini, W. Baurecht, E. Doppler and H. Moessler
Affiliation:
Keywords: Alzheimer's disease, randomized controlled trial, cerebrolysin, combination therapy, neurotrophic factor, donepezil, cholinesterase inhibitors, trophic factor, ApoE genotyping
Abstract: Treatment with neurotrophic agents might enhance and/or prolong the effects of cholinesterase inhibitors (ChEIs) in Alzheimers disease (AD). We compared the safety and efficacy of the neurotrophic compound Cerebrolysin (10 ml; n=64), donepezil (10 mg; n=66) and a combination of both treatments (n=67) in mild-to-moderate (mini-mental state examination-MMSE score 12-25) probable AD patients enrolled in a randomized, double-blind trial. Primary endpoints were global outcome (Clinicians Interview-Based Impression of Change plus caregiver input; CIBIC+) and cognition (change from baseline in AD Assessment Scale-cognitive subscale+; ADAS-cog+) at week 28. Changes in functioning (AD Cooperative Study-Activities of Daily Living scale, ADCS-ADL) and behaviour (Neuropsychiatric Inventory, NPI) were secondary endpoints. Treatment effects in cognitive, functional and behavioral domains showed no significant group differences; whereas improvements in global outcome favored Cerebrolysin and the combination therapy. Cognitive performance improved in all treatment groups (mean±SD for Cerebrolysin: -1.7±7.5; donepezil: -1.2±6.1; combination: - 2.3±6.0) with best scores in the combined therapy group at all study visits. Cerebrolysin was as effective as donepezil, and the combination of neurotrophic (Cerebrolysin) and cholinergic (donepezil) treatment was safe in mild-to-moderate AD. The convenience of exploring long-term synergistic effects of this combined therapy is suggested.
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A. Alvarez X., Cacabelos R., Sampedro C., Couceiro V., Aleixandre M., Vargas M., Linares C., Granizo E., Garcia-Fantini M., Baurecht W., Doppler E. and Moessler H., Combination Treatment in Alzheimers Disease: Results of a Randomized, Controlled Trial with Cerebrolysin and Donepezil, Current Alzheimer Research 2011; 8 (5) . https://dx.doi.org/10.2174/156720511796391863
DOI https://dx.doi.org/10.2174/156720511796391863 |
Print ISSN 1567-2050 |
Publisher Name Bentham Science Publisher |
Online ISSN 1875-5828 |
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