Back to resultsEvaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
Primary Purpose
Alzheimer's Disease
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
E2609
Placebo for E2609
Sponsored by
About this trial
This is an interventional treatment trial for Alzheimer's Disease
Eligibility Criteria
Inclusion criteria:
- Meets the current cognitive classification of MCI or mild dementia due to AD pathology (all subjects having a "positive" biomarker for amyloid β) as defined by the National Institute on Aging - Alzheimer's Association (NIA-AA) research criteria
- Aged 50 to 85 years, inclusive at time of consent
Exclusion criteria:
- Currently has any neurological condition other than AD (Alzheimer's disease)-related that could be contributing to the subject's cognitive impairment
- Significant pathological findings on brain MRI at Screening, including but not limited to multiple microhemorrhages
- Any psychiatric diagnosis or symptoms, e.g., hallucinations, major depression,anxiety or delusions that in the Investigator's opinion could interfere with assessment of cognition or confound the diagnosis of MCI or mild dementia due to AD in the subject.
- A lifetime history of cerebrovascular events or non-vasovagal related loss of consciousness within the last 10 years
- Any other abnormality of the ECG at Screening and/or Baseline (including QRS > 110 ms, abnormal electrical axis, PR interval > 220 ms and conduction abnormalities) 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 LP or insertion of an indwelling catheter for CSF sampling
- Any history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
E2609
Placebo for E2609
Arm Description
Outcomes
Primary Outcome Measures
Percent change from baseline in cerebrospinal fluid amyloid-beta levels
Secondary Outcome Measures
Incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01600859
Brief Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
October 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
65 (Actual)
8. Arms, Groups, and Interventions
Arm Title
E2609
Arm Type
Experimental
Arm Title
Placebo for E2609
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
E2609
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo for E2609
Intervention Description
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
Primary Outcome Measure Information:
Title
Percent change from baseline in cerebrospinal fluid amyloid-beta levels
Time Frame
baseline to 36 hours post-dose
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Time Frame
8 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Meets the current cognitive classification of MCI or mild dementia due to AD pathology (all subjects having a "positive" biomarker for amyloid β) as defined by the National Institute on Aging - Alzheimer's Association (NIA-AA) research criteria
Aged 50 to 85 years, inclusive at time of consent
Exclusion criteria:
Currently has any neurological condition other than AD (Alzheimer's disease)-related that could be contributing to the subject's cognitive impairment
Significant pathological findings on brain MRI at Screening, including but not limited to multiple microhemorrhages
Any psychiatric diagnosis or symptoms, e.g., hallucinations, major depression,anxiety or delusions that in the Investigator's opinion could interfere with assessment of cognition or confound the diagnosis of MCI or mild dementia due to AD in the subject.
A lifetime history of cerebrovascular events or non-vasovagal related loss of consciousness within the last 10 years
Any other abnormality of the ECG at Screening and/or Baseline (including QRS > 110 ms, abnormal electrical axis, PR interval > 220 ms and conduction abnormalities) 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 LP or insertion of an indwelling catheter for CSF sampling
Any history of seizure disorder, symptomatic seizures (not including a history of simple febrile seizures in childhood) or any past or present medical condition which, in the opinion of the investigator has the potential to reduce seizure threshold (e.g., history of head trauma or concussion, previous alcohol abuse, substance abuse).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hakop Gevorkyan
Organizational Affiliation
California Clinical Trials Medical Group Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Olukemi Olugemo, MD
Organizational Affiliation
PAREXEL International - EPCU Baltimore
Official's Role
Principal Investigator
Facility Information:
City
Glendale
State/Province
California
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
We'll reach out to this number within 24 hrs