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
2428
mi
from 91732
Staten Island, NY
Click here to add this to my saved trials
649
mi
from 91732
Albuquerque, NM
Click here to add this to my saved trials
2305
mi
from 91732
Atlantis, FL
Click here to add this to my saved trials
2686
mi
from 91732
Bangor, ME
Click here to add this to my saved trials
1589
mi
from 91732
Baton Rouge, LA
Click here to add this to my saved trials
2468
mi
from 91732
Bennington, VT
Click here to add this to my saved trials
2434
mi
from 91732
Brooklyn, NY
Click here to add this to my saved trials
2126
mi
from 91732
Brooksville, FL
Click here to add this to my saved trials
2447
mi
from 91732
Cedarhurst, NY
Click here to add this to my saved trials
Charlotte, North Carolina 28207
2102
mi
from 91732
Charlotte, NC
Click here to add this to my saved trials
2208
mi
from 91732
Charlottesville, VA
Click here to add this to my saved trials
1902
mi
from 91732
Columbus, GA
Click here to add this to my saved trials
28
mi
from 91732
Costa Mesa, CA
Click here to add this to my saved trials
1561
mi
from 91732
Creve Coeur, MO
Click here to add this to my saved trials
22
mi
from 91732
Culver City, CA
Click here to add this to my saved trials
2304
mi
from 91732
Delray Beach, FL
Click here to add this to my saved trials
East Providence, Rhode Island 02915
2564
mi
from 91732
East Providence, RI
Click here to add this to my saved trials
27
mi
from 91732
Encino, CA
Click here to add this to my saved trials
1611
mi
from 91732
Flowood, MS
Click here to add this to my saved trials
2204
mi
from 91732
Fort Myers, FL
Click here to add this to my saved trials
7988
mi
from 91732
Geelong,
Click here to add this to my saved trials
13
mi
from 91732
Glendale, CA
Click here to add this to my saved trials
Hallandale Beach, Florida 33009
2318
mi
from 91732
Hallandale Beach, FL
Click here to add this to my saved trials
1676
mi
from 91732
Hattiesburg, MS
Click here to add this to my saved trials
2315
mi
from 91732
Hialeah, FL
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
2440
mi
from 91732
Latham, NY
Click here to add this to my saved trials
2149
mi
from 91732
Leesburg, FL
Click here to add this to my saved trials
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
21
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
19
mi
from 91732
Los Alamitos, CA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
2486
mi
from 91732
New Haven, CT
Click here to add this to my saved trials
2570
mi
from 91732
Newton, MA
Click here to add this to my saved trials
2365
mi
from 91732
Norristown, PA
Click here to add this to my saved trials
2529
mi
from 91732
Norwich, CT
Click here to add this to my saved trials
1164
mi
from 91732
Oklahoma City, OK
Click here to add this to my saved trials
21
mi
from 91732
Orange, CA
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
1720
mi
from 91732
Park Ridge, IL
Click here to add this to my saved trials
343
mi
from 91732
Phoenix, AZ
Click here to add this to my saved trials
2335
mi
from 91732
Plains, PA
Click here to add this to my saved trials
2601
mi
from 91732
Plymouth, MA
Click here to add this to my saved trials
827
mi
from 91732
Portland, OR
Click here to add this to my saved trials
2400
mi
from 91732
Princeton, NJ
Click here to add this to my saved trials
510
mi
from 91732
Redding, CA
Click here to add this to my saved trials
846
mi
from 91732
Richland, WA
Click here to add this to my saved trials
570
mi
from 91732
Salt Lake City, UT
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
2402
mi
from 91732
Springfield, NJ
Click here to add this to my saved trials
2305
mi
from 91732
Sunrise, FL
Click here to add this to my saved trials
427
mi
from 91732
Tucson, AZ
Click here to add this to my saved trials
2304
mi
from 91732
West Palm Beach, FL
Click here to add this to my saved trials
1182
mi
from 91732
Wichita, KS
Click here to add this to my saved trials
2310
mi
from 91732
Williamsburg, VA
Click here to add this to my saved trials
Wilmington, North Carolina 28401
2275
mi
from 91732
Wilmington, NC
Click here to add this to my saved trials