drugset / Trial / NCT01600859

Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)

NCT01600859

Phase 1 Completed 65 enrolled Eisai Inc.
RandomizedParallel-groupTriple-blindTreatment

Summary

Subjects will be adults aged 50 to 85 years who have subjective memory complaints and mild cognitive impairment or mild dementia due to Alzheimer's disease (AD). Subjects taking thyroxine or thyroid supplements and subjects receiving an acetylcholinesterase inhibitor (AChEI) and/or memantine for AD must be on a stable dose for at least 12 weeks prior to Screening and remain on their stable dose throughout the trial. Subjects will receive placebo or a single oral dose of E2609. Safety assessments will be conducted. Additionally, the pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures.

Timeline

Start
2012-07
Primary completion
2013-09
Completion
2013-10

Drugs

EvaluationDrugModalityDoseRoute
Subject Elenbecestat Small molecule 5 mg Oral
Subject Elenbecestat Small molecule 10 mg Oral
Subject Elenbecestat Small molecule 25 mg Oral
Subject Elenbecestat Small molecule 50 mg Oral
Subject Elenbecestat Small molecule 100 mg Oral
Subject Elenbecestat Small molecule 200 mg Oral
Subject Elenbecestat Small molecule 400 mg Oral

Indications