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A Study of SB-742457, Added to Donepezil for the Treatment of Mild-to-moderate Alzheimer's Disease
Bu çalışma, hafif-orta düzeyde Alzheimer hastalığı (Alzheimer's Disease) olan kişilerde mevcut Donepezil tedavisine eklenen SB-742457 ilacını plaseboyla karşılaştırıyor. En az 6 aydır Donepezil kullanan, düzenli bakıcısı olan hastalar dahil edilmiştir. Faz 2 aşamasında yürütülmüş ve tamamlanmıştır.
Yukarıdaki özet, resmî kaydın sade dile aktarılmış halidir. Orijinal İngilizce başlık referans için gösterilir.
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Kriterler ClinicalTrials.gov kaydından orijinal İngilizce haliyle alınmıştır. Uygunluk kararını yalnızca deneyi yürüten ekip verebilir.
Inclusion Criteria: * Subjects and their caregivers must provide informed consent prior to study entry. * Subjects must have a clinical diagnosis of probable mild-to-moderate Alzheimer's disease with no evidence of disorders that are thought to be the cause of, or contributing to the severity of the subject's dementia and a documented history of at least 6 months of ongoing donepezil therapy with stable dosing for at least the last 2 months. * Subjects must have a regular caregiver who is willing to attend visits, oversee the subject's compliance with the study and report on the subject's status. * Female subjects of child-bearing potential must agree to abstinence or an approved form of birth control. * Subjects must have adequate blood pressure and laboratory values. Exclusion Criteria: * Subjects with a diagnosis of possible, probable or definite vascular dementia may not participate. * Subjects with known hypersensitivity to sunlight or a history of seizures, previous exposure to SB-742457, taking agents for which there is a theoretical risk of interaction with SB-742457, or taking medication for Alzheimer's disease or centrally acting agents which might impact study outcomes may not participate.