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Phase 3TerminatedAge-related condition

A Study to Evaluate Safety and Tolerability of Aducanumab in Participants With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Phase 3b Open-Label, Multicenter, Safety Study of BIIB037 (Aducanumab) in Subjects With Alzheimer's Disease Who Had Previously Participated in the Aducanumab Studies 221AD103, 221AD301, 221AD302 and 221AD205

Sponsor
Biogen (Industry)
Enrolment
1,696 enrolled
Conditions
Alzheimer's Disease
Interventions
Aducanumab
Ages
adults, older adults
Registry
NCT04241068, EUCTR2019-004368-22

Full record on ClinicalTrials.gov

From the registry

The primary objective is to evaluate the safety and tolerability of aducanumab over 100 weeks of treatment after a wash-out period imposed by discontinuation of feeder studies in participants who had previously received aducanumab (i.e. previously treated participants) or who had previously received placebo (i.e. treatment-naïve participants).

Primary outcomes

  • Core Treatment Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious TEAEs
  • Core Treatment Period: Number of Participants With AEs Leading to Treatment Discontinuation (TD) and Study Withdrawal (SW)
  • Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality-Edema (ARIA-E)
  • Core Treatment Period: Number of Participants With Amyloid-Related Imaging Abnormality- Hemorrhage or Superficial Siderosis (ARIA-H)

History

  1. Results first posted

  2. Last registry update

  3. Primary completion

  4. Started

  5. Registered

Papers citing this trial