The purpose of this study is to assess the long term safety, tolerability, and immunogenicity of ACC-001, an investigational active immunization product+, in subjects with mild to moderate Alzheimer's disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
160
Vanutide Cridificar (ACC-001) 3µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Vanutide Cridificar (ACC-001) 10µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
Vanutide Cridificar (ACC-001) 30 µg + QS-21 (50µg), IM on Day 1, Month 6, Month 12 and Month 18
CMRR Bordeaux CHU Pellegrin
Bordeaux, France
Hopital Roger Salengro
Lille, France
Percentage of Participants With Treatment-emergent AEs or Serious Adverse Events (SAEs)
An AE was any untoward, undesired, or unplanned clinical event in the form of signs, symptoms, disease, or laboratory or physiologic observations occurring in a person given study drug or in a sponsor's clinical study. The event did not need to be causally related to the study drug or the clinical studies. A treatment emergent AE was defined as an event that emerged during the treatment period that was absent before treatment, or worsened during the treatment period relative to the pretreatment state. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
Time frame: 24 months
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Hôpital Roger Salengro
Lille, France
CHU La Timone
Marseille, France
Groupe Hospitalier Broca-La Rochefoucauld
Paris, France
Groupe Hospitalier Pitie-Salpetriere
Paris, France
Hôpital Pitié-Salpétrière
Paris, France
Hôpital La Grave
Toulouse, France
Klinik fuer Psychiatrie und Psychotherapie, Charite Universitaetsmedizin Berlin
Berlin, Germany
Universitatsklinikum und Poliklinik der Uni Bonn
Bonn, Germany
...and 7 more locations