Alzheimer's Disease Education and Referral Center

Effects of EVP-0962 on Amyloid Levels in Cerebrospinal Fluid

Effects of EVP-0962 on Amyloid Levels in Cerebrospinal Fluid

Overall Status: 
Completed
Brief Description: 

This Phase II study is designed to determine the safety, tolerability, pharmacokinetics, and effects of EVP-0962 on levels of amyloid in the cerebrospinal fluid of healthy people and those with mild cognitive impairment (MCI)  or early Alzheimer's disease.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
45 Years
85 Years
Both
Yes
Inclusion Criteria: 

    Healthy Participants

    • Age 45 to 65
    • Body Mass Index of 18 to 32
    • Negative drug-screening test results

    Participants with MCI or Early Alzheimer's Disease

    • Age 45 to 85
    • Brain scan results compatible with diagnosis of MCI or early Alzheimer's
    • Body Mass Index of 18 to 32
    • Memory complaint; cognitive impairment in one or more areas; Clinical Dementia Rating-SB score of less than or equal  to 1.0; Mini Mental State Examination score of greater than 24
    • No impairment in social or occupational functioning
Exclusion Criteria: 
    • History of seizure disorder or symptomatic orthostatic hypotension
    • QTc values greater than 450 ms
    • Positive drug screening test results
    • Pregnant, nursing, or unwilling to use 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 Alzheimer's disease
    • Lumbar spine X-rays showing anatomic contraindications to lumbar puncture
    • History of spinal surgery or chronic low back pain
    • History of migraine headaches
Detailed Description: 

This study of the experimental drug EVP-0962 will be conducted in two parts. The first part will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of escalating EVP-0962 doses (10 mg, 50 mg, 100 mg, and 200 mg) for 14 days in healthy subjects. The second part will evaluate the same outcomes following once-daily administration for 14 days in participants with MCI or early Alzheimer's disease. EVP-0962 modulates an enzyme, gamma secretase, involved in the processing of amyloid and its toxic amyloid-beta 1-42 peptide, a key component of amyloid plaques in the brains of people with Alzheimer's disease.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 34.1527251, -118.2117257

Site
Glendale
California
91206
Name:
Phone:
Lead Sponsor: 
Agency
EnVivo Pharmaceuticals, Inc.
Collaborator Sponsor: 
Agency
PAREXEL International Corp.
Facility Investigators: 
NameRoleAffiliation
David S. Han, MD
Principal Investigator
Glendale Adventist Medical Center
Study Contact: 
NamePhoneEmail
Jeremy Casey
818-662-1066
Locations
 
 
ClinicalTrials.gov ID 
NCT01661673 (follow link to view full record on ct.gov in new window)
Official Title: 
Safety, Tolerability, Pharmacokinetics, 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
Study Start Date: 
November 2012
Study End Date: 
September 2013
Disease Stage: 
Early
Enrollment: 
52