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Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single Oral Doses of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
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.
Phase: Phase 1
Sponsor: Eisai Inc.
Eisai Medical Services
||California Clinical Trials Medical Group, Inc.
Date Last Changed: April 23, 2013