Safety, Tolerability, Pharmacokinetics of EVP-0962 and Effects of EVP-0962 on Cerebral Spinal Fluid Amyloid Concentrations in Healthy Subjects and in Subjects With Mild Cognitive Impairment or Early Alzheimer's Disease
NCT ID: NCT01661673
Last Updated: 2014-01-13
Study Results
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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COMPLETED
PHASE2
52 participants
INTERVENTIONAL
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Arm 1
10 mg EVP-0962 Orally administered once daily for 14 days
EVP-0962
Arms: 1,2,3,4
Arm 2
50 mg EVP-0962 Orally administered once daily for 14 days
EVP-0962
Arms: 1,2,3,4
Arm 3
100 mg EVP-0962 Orally administered once daily for 14 days
EVP-0962
Arms: 1,2,3,4
Arm 4
200 mg EVP-0962 Orally administered once daily for 14 days
EVP-0962
Arms: 1,2,3,4
Arm 5
Placebo orally administered for 14 days
Placebo
Arm 5
Interventions
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EVP-0962
Arms: 1,2,3,4
Placebo
Arm 5
Eligibility Criteria
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Inclusion Criteria
* Part 2: Male and female subjects between the ages of 45 to 85 (inclusive), MRI/CT scans compatible with diagnosis of MCI or early AD, meets the classification of MCI due to AD as defined by the National Institute on Aging-Alzheimer's Association, and a BMI of 18-32 kg/m2(inclusive). Subjects must meet the following Cognitive criteria: Subject Memory Complaint, cognitive impairment in one or more areas, CDR-SB score less than or equal 1.0, MMSE greater than 24, and no impairment in social or occupational functioning.
Exclusion Criteria
* Pregnancy, nursing, (or if fertile female) not willing to utilize birth control measures during study
* C-SSRS suicidal ideation score of 4 or 5
* Unwilling to abstain from vigorous exercise
* Concurrent disease other than MCI or early AD that is attributing to patient's cognitive impairment.
* Lumbar spine X-rays show anatomic contraindications to lumbar puncture
* History of spinal surgery or chronic low back pain
* History of migraine headaches
45 Years
85 Years
ALL
Yes
Sponsors
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Parexel
INDUSTRY
FORUM Pharmaceuticals Inc
INDUSTRY
Responsible Party
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Locations
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Glendale Adventist Medical Center
Glendale, California, United States
Countries
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Other Identifiers
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EVP-0962-002
Identifier Type: -
Identifier Source: org_study_id
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