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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)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT01600859
First received: May 15, 2012
Last updated: October 10, 2013
Last verified: October 2013

May 15, 2012
October 10, 2013
May 2012
September 2013   (final data collection date for primary outcome measure)
Percent change from baseline in cerebrospinal fluid amyloid-beta levels [ Time Frame: baseline to 36 hours post-dose ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01600859 on ClinicalTrials.gov Archive Site
Incidence of adverse events [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Evaluation of E2609 in Subjects With Mild Cognitive Impairment or Mild Dementia Due to Alzheimer's Disease (Study: E2609-A001-101 Amendment 02)
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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Alzheimer's Disease
  • 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

  • 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

  • Experimental: E2609
    Intervention: Drug: E2609
  • Placebo Comparator: Placebo for E2609
    Intervention: Drug: Placebo for E2609
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
October 2013
September 2013   (final data collection date for primary outcome measure)

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).
Both
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01600859
E2609-A001-101
Not Provided
Eisai Inc.
Eisai Inc.
Not Provided
Principal Investigator: Hakop Gevorkyan California Clinical Trials Medical Group Inc.
Principal Investigator: Olukemi Olugemo, MD PAREXEL International - EPCU Baltimore
Eisai Inc.
October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP