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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)

NCT01600859 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 65

Last updated 2016-12-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

E2609

E2609 capsules: 5 mg, 25 mg, 50 mg, and 200 mg E2609 doses: 5 mg, 10 mg, 25 mg, 50 mg, 100 mg, 200 mg, and 400 mg According to the randomized study design, participants who are assigned to receive E2609 will each receive a single assigned dose consisting of two capsules of E2609 or in some cases one capsule of E2609 and one of placebo

DRUG

Placebo for E2609

Placebo capsules According to the randomized study design, participants who are assigned to receive placebo will each receive a single dose consisting of two capsules of placebo

Sponsors & Collaborators

  • Eisai Inc.

    lead INDUSTRY

Principal Investigators

  • Hakop Gevorkyan · California Clinical Trials Medical Group Inc.

  • Olukemi Olugemo, MD · PAREXEL International - EPCU Baltimore

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-09-30
Completion
2013-10-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01600859 on ClinicalTrials.gov