Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
- Registration Number
- NCT01600859
- Lead Sponsor
- Eisai Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 65
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description E2609 E2609 - Placebo for E2609 Placebo for E2609 -
- Primary Outcome Measures
Name Time Method Percent change from baseline in cerebrospinal fluid amyloid-beta levels baseline to 36 hours post-dose
- Secondary Outcome Measures
Name Time Method Incidence of adverse events 8 days