Study of the Safety and Clinical Effects of 2 Doses of EVP-6124 in Subjects With Alzheimer's Disease Who Complete Study EVP-6124-024 or EVP-6124-025
Status: | Terminated |
---|---|
Conditions: | Alzheimer Disease, Neurology |
Therapuetic Areas: | Neurology |
Healthy: | No |
Age Range: | 55 - 85 |
Updated: | 5/4/2016 |
Start Date: | June 2014 |
End Date: | August 2017 |
A 26-Week Extension Study of the Safety and Clinical Effects of EVP-6124 in Subjects With Alzheimer's Disease Currently or Previously Receiving an Acetylcholinesterase Inhibitor Medication
This is a 26-week, randomized extension of the Phase 3 double-blind placebo-controlled
studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study
EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive
EVP-6124 for an additional 26 weeks.
studies, EVP-6124-024 and EVP-6124-025. In this extension study, subjects who complete study
EVP-6124-024 or EVP-6124-025 and fulfill all entry criteria will be randomized to receive
EVP-6124 for an additional 26 weeks.
Inclusion Criteria:
- Male or female subjects of any race, aged ≥55 and ≤85 years at time of entry into
study EVP-6124-024 or EVP-6124-025
- Informed consent form (ICF) for this extension study signed by the subject or legally
acceptable representative and an ICF signed by the support person/caregiver before
initiation of any study-specific procedures
- Successful completion (Day 182) of study EVP-6124-024 or EVP-6124-025
- No clinically significant change in the judgment of the investigator in the subject's
medical status during study EVP-6124-024 or EVP-6124-025
- In the judgment of the investigator, extension treatment is in the best interest of
the subject
- 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 [including at least 1 barrier method])
- Reliable and capable support person/caregiver, who if not living in the same
household, interacts with the subject approximately 4 times per week and will be
available to attend clinic visits in person when possible
Exclusion Criteria:
- Significant risk of suicidal or violent behavior in the judgment of the investigator
- Adverse events from the previous study (EVP-6124-024 or EVP-6124-025) that have not
resolved, are moderate or severe, judged to be possibly related or related to study
drug, and considered by the investigator to be a contraindication to extension study
participation
- Any condition that would make the subject in the judgment of the investigator
unsuitable for the study
- Female subjects who are pregnant, nursing, or planning to become pregnant during the
extension study
We found this trial at
57
sites
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