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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 ...

Update Il y a 4 ans
Reference: EUCTR2009-010922-21

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

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Extract

The primary objective of the study is to evaluate the long-term safety and tolerability of doses of 3, 10, and 30 µg of ACC-001 (CRM-conjugated A-beta [1-7] antigen alone and in combination with QS-21 adjuvant) in subjects with mild to moderate AD.

Inclusion criteria

  • Patients with mild to moderate Alzheimer's disease. Enfermedad de Alzheimer

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