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

NCT01600859 | Completed Phase 1

• 1 other identifier: E2609-A001-101
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

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.

Conditions

Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

• Percent change from baseline in cerebrospinal fluid amyloid-beta levels

  baseline to 36 hours post-dose

Secondary Outcomes (1)

• Incidence of adverse events

  8 days

Study Arms (2)

E2609

EXPERIMENTAL

Drug: E2609

Placebo for E2609

PLACEBO COMPARATOR

Drug: Placebo for E2609

Interventions

E2609 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

E2609

Placebo for E2609 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

Placebo for E2609

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Eisai Inc.: lead

Study Sites (2)

Unknown Facility

Glendale, California, United States

Location

Unknown Facility

Baltimore, Maryland, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Hakop Gevorkyan

  California Clinical Trials Medical Group Inc.

  PRINCIPAL INVESTIGATOR

• Olukemi Olugemo, MD

  PAREXEL International - EPCU Baltimore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2012
• First Posted: May 17, 2012
• Study Start: July 1, 2012
• Primary Completion: September 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 30, 2016

Record last verified: 2016-12

Locations

US (2)