E2609 for Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
E2609 for Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease
Overall Status:
Recruiting
Brief Description:
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.
Patient Qualifications:
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | 85 Years | Both | No |
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Detailed Description:
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.
Central Contact Information:
Eisai Medical Services 1-888-422-4743
Locations:
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 34.1425078, -118.255075 | Glendale | California | Recruiting | Name: Phone: | ||
Geolocation is 39.2903848, -76.6121893 | Baltimore | Maryland | Recruiting | Name: Phone: |
Lead Sponsor:
| Agency |
|---|
Eisai Inc. |
Collaborator Sponsor:
Facility Investigators:
| Name | Role | Affiliation |
|---|---|---|
Hakop Gevorkyan, MD | Principal Investigator | California Clinical Trials Medical Group, Inc. |
Study Contact:
| Name | Phone |
|---|---|
Eisai Medical Services | 1-888-422-4743 |
Locations
ClinicalTrials.gov ID
NCT01600859 (follow link to view full record on ct.gov in new window)
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
Study Start Date:
May 2012
Study End Date:
November 2013
Disease Stage:
Early
Enrollment:
50
