Evaluating Effect of the Study Drug Praluent (Alirocumab) on Neurocognitive Function When Compared to Placebo



Status:Active, not recruiting
Conditions:High Cholesterol
Therapuetic Areas:Cardiology / Vascular Diseases
Healthy:No
Age Range:40 - 85
Updated:5/12/2018
Start Date:November 18, 2016
End Date:May 4, 2020

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

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Effect of Praluent on Neurocognitive Function in Patients With Heterozygous Familial Hypercholesterolemia or With Non-Familial Hypercholesterolemia at High and Very High Cardiovascular Risk

The main purpose of this study is to evaluate the effect on mental state (known as
"neurocognitive function") with use of Praluent.


Inclusion Criteria:

- Men and women ≥ age 40 years and ≤ age 85 years

- Patients with heterozygous familial hypercholesterolemia (heFH) or with non-familial
hypercholesterolemia (non-FH) patients at high or very high cardiovascular risk

- Patients with history of coronary heart disease (CHD) not having adequate control of
their hypercholesterolemia with LDL-C ≥70 mg/dL, or all other patients with LDL-C ≥100
mg/dL and be on maximally-tolerated dose of statin (unless they are statin-intolerant)

- Patients must have successfully completed the Motor Screening Task

- Patients must be willing and able to comply with clinic visits and study related
procedures

- Patients must provide signed informed consent

Exclusion Criteria:

- Patients with known Alzheimer's disease or other dementia, schizophrenia, bipolar
disorder, severe depression, cognitive impairment, or patients with a sleep disorder
requiring daily pharmacological treatment

- Recent (within 3 months prior to the screening visit) myocardial infarction, unstable
angina leading to hospitalization, coronary artery bypass graft surgery, percutaneous
coronary intervention, uncontrolled cardiac arrhythmia, carotid surgery or stenting,
stroke, transient ischemic attack, carotid revascularization, endovascular procedure
or surgical intervention for peripheral vascular disease

- Certain laboratory findings obtained during the screening visit

- Any condition or situation, including other significant mental or neurological
disorders that, in the investigator's opinion, may confound the study results, or may
interfere significantly with the patient's participation in the study

- Pregnant or breastfeeding women

- A positive human immunodeficiency virus (HIV) test

The information listed above is not intended to contain all considerations relevant to a
patient's potential participation in this clinical trial and not all inclusion/exclusion
criteria are listed
We found this trial at
65
sites
?
mi
from
Everett, WA
Click here to add this to my saved trials
?
mi
from
Alexander City, AL
Click here to add this to my saved trials
?
mi
from
Ames, IA
Click here to add this to my saved trials
?
mi
from
Atlantis, FL
Click here to add this to my saved trials
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
?
mi
from
Bangor, ME
Click here to add this to my saved trials
Beverly Hills, California 90211
?
mi
from
Beverly Hills, CA
Click here to add this to my saved trials
?
mi
from
Birmingham, AL
Click here to add this to my saved trials
?
mi
from
Bristol, TN
Click here to add this to my saved trials
?
mi
from
Buffalo, NY
Click here to add this to my saved trials
?
mi
from
Champaign, IL
Click here to add this to my saved trials
Charleston, South Carolina 29412
?
mi
from
Charleston, SC
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
Chicago, IL
Click here to add this to my saved trials
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
?
mi
from
Cleveland, OH
Click here to add this to my saved trials
Colorado Springs, Colorado 80910
?
mi
from
Colorado Springs, CO
Click here to add this to my saved trials
?
mi
from
Covington, GA
Click here to add this to my saved trials
?
mi
from
Dallas, TX
Click here to add this to my saved trials
?
mi
from
Dayton, OH
Click here to add this to my saved trials
?
mi
from
Denver, CO
Click here to add this to my saved trials
Duncansville, Pennsylvania 16635
?
mi
from
Duncansville, PA
Click here to add this to my saved trials
?
mi
from
Evansville, IN
Click here to add this to my saved trials
?
mi
from
Falls Church, VA
Click here to add this to my saved trials
Greensboro, North Carolina 27401
?
mi
from
Greensboro, NC
Click here to add this to my saved trials
Greenville, South Carolina 29605
?
mi
from
Greenville, SC
Click here to add this to my saved trials
?
mi
from
Hickory, NC
Click here to add this to my saved trials
?
mi
from
High Point, NC
Click here to add this to my saved trials
?
mi
from
Houston, TX
Click here to add this to my saved trials
?
mi
from
Hutchinson, KS
Click here to add this to my saved trials
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
Jefferson City, Tennessee 37760
?
mi
from
Jefferson City, TN
Click here to add this to my saved trials
?
mi
from
Knoxville, TN
Click here to add this to my saved trials
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Los Gatos, CA
Click here to add this to my saved trials
?
mi
from
Louisville, KY
Click here to add this to my saved trials
?
mi
from
Manitowoc, WI
Click here to add this to my saved trials
?
mi
from
Miami Springs, FL
Click here to add this to my saved trials
?
mi
from
Mobile, AL
Click here to add this to my saved trials
?
mi
from
New Hyde Park, NY
Click here to add this to my saved trials
?
mi
from
Newton, KS
Click here to add this to my saved trials
North Hollywood, California 91606
?
mi
from
North Hollywood, CA
Click here to add this to my saved trials
Olive Branch, Mississippi 38654
?
mi
from
Olive Branch, MS
Click here to add this to my saved trials
?
mi
from
Overland Park, KS
Click here to add this to my saved trials
?
mi
from
Oxon Hill, MD
Click here to add this to my saved trials
?
mi
from
Pleven,
Click here to add this to my saved trials
?
mi
from
Port Hueneme, CA
Click here to add this to my saved trials
?
mi
from
Puyallup, WA
Click here to add this to my saved trials
?
mi
from
Raleigh, NC
Click here to add this to my saved trials
?
mi
from
Rapid City, SD
Click here to add this to my saved trials
?
mi
from
Rock Island, IL
Click here to add this to my saved trials
?
mi
from
Rocky Mount, NC
Click here to add this to my saved trials
Salisbury, North Carolina 28144
?
mi
from
Salisbury, NC
Click here to add this to my saved trials
?
mi
from
Schertz, TX
Click here to add this to my saved trials
?
mi
from
Shavano Park, TX
Click here to add this to my saved trials
Statesville, North Carolina 28677
?
mi
from
Statesville, NC
Click here to add this to my saved trials
Summerville, South Carolina 29485
?
mi
from
Summerville, SC
Click here to add this to my saved trials
?
mi
from
Walla Walla, WA
Click here to add this to my saved trials
?
mi
from
Washington, MO
Click here to add this to my saved trials
?
mi
from
Waterloo, IA
Click here to add this to my saved trials
?
mi
from
Westminster, CA
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
?
mi
from
Winchester, VA
Click here to add this to my saved trials
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials