Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: E2609 Drug: Placebo for E2609 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
- Percent change from baseline in cerebrospinal fluid amyloid-beta levels [ Time Frame: baseline to 36 hours post-dose ] [ Designated as safety issue: No ]
- Incidence of adverse events [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 50 |
| Study Start Date: | May 2012 |
| Estimated Study Completion Date: | November 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: E2609 |
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 |
| Placebo Comparator: Placebo for E2609 |
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 |
Eligibility| Ages Eligible for Study: | 50 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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).
Contacts and Locations| Contact: Eisai Medical Services | 1-888-422-4743 |
| United States, California | |
| California Clinical Trials Medical Group, Inc. | Recruiting |
| Glendale, California, United States | |
| Contact: Hakop Gevorkyan | |
| Principal Investigator: | Hakop Gevorkyan | California Clinical Trials Medical Group Inc. |
More Information
No publications provided
| Responsible Party: | Eisai Inc. |
| ClinicalTrials.gov Identifier: | NCT01600859 History of Changes |
| Other Study ID Numbers: | E2609-A001-101 |
| Study First Received: | May 15, 2012 |
| Last Updated: | April 23, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Cognition Disorders Brain Diseases Central Nervous System Diseases |
Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 19, 2013