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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)

NCT ID: NCT01600859

Last Updated: 2016-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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E2609

Group Type EXPERIMENTAL

E2609

Intervention Type DRUG

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 for E2609

Group Type PLACEBO_COMPARATOR

Placebo for E2609

Intervention Type DRUG

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

Interventions

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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

Intervention Type 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

Intervention Type DRUG

Eligibility Criteria

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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).
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eisai Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hakop Gevorkyan

Role: PRINCIPAL_INVESTIGATOR

California Clinical Trials Medical Group Inc.

Olukemi Olugemo, MD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL International - EPCU Baltimore

Locations

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Glendale, California, United States

Site Status

Baltimore, Maryland, United States

Site Status

Countries

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United States

Other Identifiers

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E2609-A001-101

Identifier Type: -

Identifier Source: org_study_id