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E2609 for Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease

Completed

The safety and effectiveness of the experimental drug E2609 will be tested in participants with subjective memory complaints and mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease in this Phase I trial. E2609 has been shown to reduce the amount of harmful beta-amyloid in the brain by inhibiting an enzyme that leads to its accumulation.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years 85 Years Both No
May 2012
November 2013
50

  • Mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease as defined by the National Institute on Aging-Alzheimer's Association (NIA-AA) research criteria (all subjects having a positive biomarker for -beta-amyloid)

  • Neurological condition other than Alzheimer's disease that could contribute to cognitive impairment
  • Significant pathological findings on brain MRI at screening, including but not limited to multiple microhemorrhages
  • Any psychiatric diagnosis or symptoms such as hallucinations, major depression, anxiety, or delusions that could interfere with assessment of cognition or confound the diagnosis of MCI or mild dementia
  • Lifetime history of cerebrovascular events or non-vasovagal-related loss of consciousness within the last 10 years
  • Any other electrocardiogram abnormality considered clinically significant by the investigator
  • History of cardiac arrhythmias, ischemic heart disease, or cerebrovascular disease
  • Lower spinal malformation on physical or lumbar spine radiography, local spinal infection, or other abnormality, including but not limited to obesity, that would prevent lumbar puncture or insertion of an indwelling catheter for cerebrospinal fluid sampling
  • History of seizure disorder, symptomatic seizures (excluding simple febrile seizures in childhood), or any past or present medical condition such as history of head trauma or concussion, previous alcohol abuse, or substance abuse

Participants will take either a placebo or one of several different doses of the study drug. The pharmacokinetics of E2609 and drug effects will be evaluated using cerebrospinal fluid biomarkers and cognitive and psychological measures. E2609 has been shown to reduce the amount of harmful beta-amyloid in the brain by inhibiting an enzyme that leads to its accumulation.

Fore more information about this study, contact Eisai Medical Services at 1-888-422-4743.

Name City State Zip Status Primary Contact
n/a
Glendale California n/a

n/a
Baltimore Maryland n/a

Eisai Inc.

Name Role Affiliation
Olukemi Olugemo, MD Principal Investigator PARAEXEL International-EPCU Baltimore

Name Phone Email
Eisai Medical Services 1-888-422-4743

NCT01600859

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