Autopsy report · NCT02322021

Dose-Finding Study To Evaluate Safety, Tolerability, and Efficacy of E2609 in Participants With Mild Cognitive Impairment Due to Alzheimer's Disease (Prodromal Alzheimer's Disease) and Mild to Moderate Dementia Due to Alzheimer's Disease

“This study was terminated early by the sponsor on the recommendation of an independent data safety monitoring board following review of unblinded data from the Phase 3 studies E2609-G000-301 (NCT02956486) and E2609-G000-302 (NCT03036280).”

The sponsor’s own words in the registry.

Life of this trial

• Ran for about 5 years 1 month before it stopped.
• 70 participants enrolled.
• Results were posted on the registry 1 year 3 months after it ended.

Vital statistics

Status

Terminated

Phase

Phase 2

Sponsor

Eisai Inc.

Sponsor type

Industry

Conditions

Alzheimer Disease; Dementia, Alzheimer Type

Interventions

E2609; Placebo

Participants

70

Sites

21

Countries

United States

Trials that died the same way

• To Assess The Efficacy and Safety Of Oral Sildenafil in the Treatment of Pulmonary Arterial Hypertension.
  “This study was terminated at the recommendation of an independent Data Monitoring Committee. The decision was not based on any safety concerns.” (70% match in meaning)
• Methylprednisolone in Patients With Cognitive Deficits in Post-COVID-19 Syndrome (PCS)
  “Following a recommendation from the Data Safety Monitoring Board (DSMB).” (63% match in meaning)
• The Efficacy of Enteric-coated Mycophenolate Sodium (EC-MPS) (Myfortic) in The Treatment of Relapse or Resistant Proliferative Lupus Nephritis
  “Data Safety Monitoring Board concerning of the participants' safety” (62% match in meaning)
• Extension Study of ACE-031 in Subjects With Duchenne Muscular Dystrophy
  “This study was terminated based on preliminary safety data.” (62% match in meaning)
• High Resolution Imaging of Cerebral Vasculature by Functional Micro-Doppler Sonography During Brain Surgery
  “recommandation of the Data Safety monitoring Board” (61% 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.