Clinical Trials

Date: 2015-09-08

Type of information: Recruitment of the first patient

phase: 3

Announcement: recruitment of the first patient

Company: Biogen (USA - MA)

Product: aducanumab (BIIB037)

Action mechanism:

  • monoclonal antibody. Aducanumab (BIIB037) is a human recombinant monoclonal antibody selected from a population of elderly, healthy donors and cognitively stable patients using Neurimmune’s technology platform called Reverse Translational Medicine (RTM). Biogen Idec licensed aducanumab from Neurimmune under a collaborative development and license agreement. Aducanumab targets aggregated forms of beta amyloid including soluble oligomers and insoluble fibrils deposited into the amyloid plaque in the brain of AD patients. Based on pre-clinical and interim Phase 1b data, treatment with aducanumab has been shown to reduce amyloid plaque level.

Disease: Alzheimer's disease

Therapeutic area: Neurodegenerative diseases

Country: Belgium, Canada, Czech Republic, France, Germany, Italy, Netherlands, Poland, Spain, Sweden, Switzerland , UK, USA

Trial details:

  • The EMERGE study is a phase 3 multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aducanumab (BIIB037) in subjects with early Alzheimer\'s disease.. The primary objective of the study is to evaluate the efficacy of monthly doses of aducanumab in slowing cognitive and functional impairment as measured by changes in the Clinical Dementia Rating-Sum of Boxes (CDR-SB) score as compared with placebo in participants with early AD. Secondary objectives are to assess the effect of monthly doses of aducanumab as compared with placebo on clinical progression as measured by Mini-Mental State Examination (MMSE), AD Assessment Scale-Cognitive Subscale (13 items) [ADAS-Cog 13], and AD Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) [ADCS-ADL-MCI]. (NCT02484547)

Latest news:

  • • On September 08, 2015, Biogen announced that the first patient has been enrolled in the Phase 3 clinical program for its aducanumab. The Phase 3 program includes two global, placebo-controlled studies named ENGAGE and EMERGE, which are designed to evaluate the efficacy and safety of aducanumab in slowing cognitive impairment and the progression of disability in people with early Alzheimer’s disease. ENGAGE and EMERGE will assess the efficacy and safety of aducanumab in approximately 2,700 people with early AD. The studies are identical in design and eligibility criteria. Each study will be conducted in more than 20 countries in North America, Europe and Asia.
  • The enrollment of the first patient in the Phase 3 program for aducanumab triggers a $60 million milestone payment to Neurimmune in the third quarter of 2015.

Is general: Yes