EUCTR2013-002653-30-IT
Active, not recruiting
Not Applicable
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, 26-Week, Phase 3 Study of Two Doses of EVP-6124 or Placebo in Subjects with Mild to Moderate Alzheimer’s Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
EnVivo Pharmaceuticals, Inc.0 sites790 target enrollmentDecember 30, 2013
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- EnVivo Pharmaceuticals, Inc.
- Enrollment
- 790
- Status
- Active, not recruiting
- Last Updated
- 10 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
- •1\. Informed consent form (ICF) signed by the subject or legally acceptable representative before any study\-specific procedures for the subject are performed and an ICF signed by the support person/caregiver before any study\-specific procedures for the support person/caregiver are performed.
- •2\. Male or female subjects of any race, aged \=55 and \=85 years
- •3\. Clinical diagnosis of dementia due to probable AD consistent with criteria established by a workgroup of the National Institute on Aging and the Alzheimer’s Disease Association (McKhann et al, 2011\)
- •4\. Clinical decline within 12 months before screening and onset of symptoms at least 12 months or longer before screening, which may include any documented cognition, functional, or other objective assessment or the clinical judgment of the investigator or the subject’s referring physician that the subject has experienced a clinical decline within the last 12 months
- •5\. Magnetic resonance imaging (MRI) or computed tomography (CT) scan performed within 12 months before screening, with findings consistent with the diagnosis of dementia due to AD without any other clinically significant comorbid pathologies. If an MRI or CT scan is unavailable or occurred greater than 12 months before screening, this assessment should be completed and the findings confirmed before the subject enters the run\-in period (Day \-14\) (copy of the report will be available at the study site)
- •6\. Mini\-Mental State Examination (MMSE) score \=14 and \=24 at screening and confirmed on Day 1 prior to randomization (fluctuations of ±2 points are acceptable on Day 1/baseline)
- •7\. Clinical Dementia Rating Global score (CDR\-GS) \=1 (at least mild dementia) at screening and confirmed on Day 1 prior to randomization
- •8\. Modified Hachinski Ischemic Scale (mHIS) score \=4 at screening
- •9\. Fertile, sexually active subjects (men and women) must use an effective method of contraception during the study. Female subjects and the female partner of male subjects must be surgically sterile (hysterectomy or bilateral tubal ligation), postmenopausal for at least 1\-year, or willing to practice adequate methods of contraception if of childbearing potential (defined as consistent use of combined effective methods of contraception.
Exclusion Criteria
- •Subjects who meet any of the following exclusion criteria will be excluded from participating in the study:
- •Exclusion Criteria \- General
- •1\. Exposure to an experimental drug, experimental biologic or experimental medical device within 2 months (60 days) before screening
- •2\. Prior participation in an amyloid vaccination clinical study at any time in the past or completion of a passive amyloid vaccination study within 6 months before screening
- •3\. Inability to swallow a tablet
- •4\. In the judgment of the investigator, inability of the subject or the support person/caregiver to complete a 26\-week study
- •5\. Inability to be \=75% compliant with single\-blind study drug
- •6\. Inability to adequately cooperate or complete the cognitive testing procedures or any study assessment
- •7\. Residence in a skilled nursing facility
- •Exclusion Criteria \- Medical
Outcomes
Primary Outcomes
Not specified
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