Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)



Status:Completed
Conditions:Alzheimer Disease, Cognitive Studies, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:50 - 85
Updated:12/31/2016
Start Date:July 2012
End Date:October 2013

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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

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.


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).
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