Autopsy report · NCT01677572

Multiple Dose Study of Aducanumab (BIIB037) (Recombinant, Fully Human Anti-Aβ IgG1 mAb) in Participants With Prodromal or Mild Alzheimer's Disease

“Study was discontinued based on futility analysis conducted on Phase 3 trials (NCT02477800 and NCT02484547) and not based on safety concerns.”

The sponsor’s own words in the registry.

Life of this trial

• Registered 1 month before it started.
• Ran for about 6 years 10 months before it stopped.
• 197 participants enrolled.
• No results are posted on the registry.

Vital statistics

Status

Terminated

Phase

Phase 1

Sponsor

Biogen

Sponsor type

Industry

Conditions

Alzheimer's Disease

Interventions

Aducanumab (recombinant, fully human anti-Aβ IgG1 mAb); Placebo

Participants

197

Sites

32

Countries

United States

Trials that died the same way

• A Study of Idasanutlin With Cytarabine Versus Cytarabine Plus Placebo in Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)
  “The study was stopped for futility based on efficacy results at the interim analysis; no unexpected safety findings were observed.” (74% match in meaning)
• Magrolimab + Azacitidine Versus Azacitidine + Placebo in Untreated Participants With Myelodysplastic Syndrome (MDS)
  “Study discontinued due to futility based on a planned analysis” (73% match in meaning)
• A Study to Evaluate Long Term Safety and Efficacy of Recombinant Human Pentraxin-2 (rhPTX-2; PRM-151) in Participants With Idiopathic Pulmonary Fibrosis
  “The study was terminated by Sponsor as the futility analysis outcome indicated that the study was unlikely to meet the predefined primary objective of the study. No new safety concerns were identified.” (71% match in meaning)
• Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
  “As no safety warnings were detected, Interim analysis from the first 40 patients recommends to stop the trial for futility” (70% match in meaning)
• Removal Versus Retention of Cerclage in Preterm Premature Rupture of Membranes (PPROM)
  “This trial was terminated following a futility analysis confirming futility of continuing the study” (70% match in meaning)

Look deeper

• The official registry record (the source of truth)
• Record history: every change the sponsor made
• Open it in the database

Everything here comes from the current ClinicalTrials.gov record. The timeline uses the record’s dates; dates marked planned are the sponsor’s plans. The cause of death is an automatic, unverified label. This is research information, not medical advice.