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

Use our guide to learn which trials are right for you!

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.


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
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
?
mi
from
Baton Rouge, LA
Click here to add this to my saved trials
?
mi
from
Bennington, VT
Click here to add this to my saved trials
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Cedarhurst, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28207
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
?
mi
from
Charlottesville, VA
Click here to add this to my saved trials
?
mi
from
Columbus, GA
Click here to add this to my saved trials
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
?
mi
from
Creve Coeur, MO
Click here to add this to my saved trials
?
mi
from
Culver City, CA
Click here to add this to my saved trials
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
East Providence, Rhode Island 02915
?
mi
from
East Providence, RI
Click here to add this to my saved trials
?
mi
from
Encino, CA
Click here to add this to my saved trials
?
mi
from
Flowood, MS
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
?
mi
from
Geelong,
Click here to add this to my saved trials
?
mi
from
Glendale, CA
Click here to add this to my saved trials
Hallandale Beach, Florida 33009
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
?
mi
from
Hattiesburg, MS
Click here to add this to my saved trials
?
mi
from
Hialeah, FL
Click here to add this to my saved trials
?
mi
from
Jacksonville, FL
Click here to add this to my saved trials
?
mi
from
Latham, NY
Click here to add this to my saved trials
?
mi
from
Leesburg, FL
Click here to add this to my saved trials
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
?
mi
from
Los Alamitos, CA
Click here to add this to my saved trials
?
mi
from
Miami, FL
Click here to add this to my saved trials
?
mi
from
New Haven, CT
Click here to add this to my saved trials
?
mi
from
Newton, MA
Click here to add this to my saved trials
?
mi
from
Norristown, PA
Click here to add this to my saved trials
?
mi
from
Norwich, CT
Click here to add this to my saved trials
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orange, CA
Click here to add this to my saved trials
?
mi
from
Orlando, FL
Click here to add this to my saved trials
?
mi
from
Park Ridge, IL
Click here to add this to my saved trials
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
?
mi
from
Plains, PA
Click here to add this to my saved trials
?
mi
from
Plymouth, MA
Click here to add this to my saved trials
?
mi
from
Portland, OR
Click here to add this to my saved trials
?
mi
from
Princeton, NJ
Click here to add this to my saved trials
?
mi
from
Redding, CA
Click here to add this to my saved trials
?
mi
from
Richland, WA
Click here to add this to my saved trials
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
?
mi
from
San Antonio, TX
Click here to add this to my saved trials
?
mi
from
San Diego, CA
Click here to add this to my saved trials
?
mi
from
Springfield, NJ
Click here to add this to my saved trials
?
mi
from
Staten Island, NY
Click here to add this to my saved trials
?
mi
from
Sunrise, FL
Click here to add this to my saved trials
?
mi
from
Tucson, AZ
Click here to add this to my saved trials
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
?
mi
from
Wichita, KS
Click here to add this to my saved trials
?
mi
from
Williamsburg, VA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
?
mi
from
Wilmington, NC
Click here to add this to my saved trials