A phase II a , Multicenter, Randomized , Third -party Unblinded , Long- term Extension study to Determine Safety, Tolerability and Immunogenicity of ACC-001 with and without QS21 Adjuvant in Subjects with Mild to Moderate Alzheimzer's Disease ?Estudio de fase IIa, multicéntrico, aleatorizado y con tercera parte conocedora del tratamiento, de extensión a largo plazo, para determinar la seguridad, la tolerabilidad y la inmunogenicidad de ACC-001, con y sin adyuvante QS-21, en sujetos con enfermedad de Alzheimer de grado leve a moderado

Wyeth Pharmaceuticals France, Wyeth Research Division0 个研究点目标入组 64 人开始时间: 2009年7月13日最近更新: 2014年3月10日

试验速览

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•1.Subjects were randomized under previous 3134K1-200-EU study and met all inclusion/and none of the exclusion criteria.
•2.Subject must have completed through week 78 of study 3134K1-200-EU and received at least 3 doses of investigational product and has been compliant in the opinion of the investigator and sponsor.
•3.Screening brain MRI scan is consistent with the diagnosis of AD.
•4.Mini-Mental State Examination (MMSE) score >10.
•5.Lives at home with appropriate caregiver capable of accompanying the subject on all clinic visits, or community dwelling with caregiver capable of accompanying the subject on all clinic visits and visiting with the subject approximately 5 times per week for the duration of the study.
•6.In the opinion of the investigator, the subject and the caregiver will be compliant and have a high probability of completing the study.
•7.The subject and caregiver are likely to be able to participate in all scheduled examinations and complete all required tests.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•1.Significant neurological disease other than AD that may affect cognition or function.
•2.Early termination (ET) from the preceding 3134K1 200-EU study.
•3.Experienced a SAE in the preceding double-blind study deemed related to investigational product.
•4.Brain MRI evidence of vasogenic edema (VE) during the preceding 3134K1 200-EU study.
•5.History of screening visit brain MRI scan indicative of any other significant abnormality including but not limited to multiple microhemorrhages (2 or more), evidence of a single prior hemorrhage > 1 cm3, multiple lacunar infarcts (2 or more) or evidence of a single prior infarct > 1 cm3, evidence of a cerebral contusion, encephalomalacia, aneurysms, vascular malformations, subdural hematoma, or space-occupying lesions
•(eg, arachnoid cysts or brain tumors, such as meningioma).
•6.Current clinically important systemic illness that is likely to result in deterioration of the subject?s condition or affect the subject?s safety during the study.
•7.Other clinically significant abnormality on screening visit which includes physical, neurological, laboratory, or electrocardiogram (ECG) examination (eg, atrial fibrillation) that could compromise the study or be detrimental to the subject.
•8.Presence of pacemakers, aneurysm clips, artificial heart valves, ear implants, cerebrospinal fluid (CSF) shunts, or metal fragments or foreign objects in the eyes, skin, or body, or claustrophobia that would contraindicate a brain MRI scan.

发起方

Wyeth Pharmaceuticals France, Wyeth Research Division