AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext



Status:Completed
Conditions:Alzheimer Disease
Therapuetic Areas:Neurology
Healthy:No
Age Range:66 - 90
Updated:5/18/2017
Start Date:March 2013
End Date:April 14, 2017

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

A 26-Week, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Investigate the Effects of Daily Administration of AC-1204 in Participants With Mild to Moderate Alzheimer's Disease (AD) With an Optional 26-Week Open Label Extension

This study will evaluate the effects of daily dosing of AC-1204 on cognition, activities of
daily living, resource utilization, quality of life, pharmacokinetic measures and safety
among participants with mild to moderate Alzheimer's Disease.


Inclusion Criteria:

- Dementia status of mild to moderate

- CT or MRI scan within 18 months prior to screening compatible with a diagnosis of
probable Alzheimer's disease

- Score on the Wechsler Memory Scale - Logical Memory II recall below a pre-determined
cut-off, adjusted for education level

- Confirmed apolipoprotein E genotype prior to randomization

- Prior and current use of medication that corresponds with protocol requirements

- Stable medical condition, with the exception of dementia, for at least 3 consecutive
months prior to screening

- No active suicidal thoughts within 6 months of screening, no active history of
suicide attempt in the previous 2 years, no more than 1 lifetime suicide attempt, no
serious suicidal risk

- Able to comply with protocol testing and procedures for the duration of the study

- Has a permanent caregiver (caregiver is not expected to change during the course of
the study) who is willing to attend all visits, oversee the participant's compliance
with protocol procedures and study medication administration, and report on the
participant's status

- Resides in the community (includes assisted living facilities, but excludes long-term
care nursing facilities)

- Both participant and caregiver have the ability to read and write in English or
Spanish and have hearing, vision and physical abilities adequate to perform the
assessments (corrective aids allowed)

- Participant and caregiver have provided full written informed consent prior to the
performance of any protocol-specified procedure. If participant is unable to provide
informed consent due to cognitive status, provision of informed consent by
cognitively intact legally acceptable representative (where this is in accordance
with local laws, regulations and ethics committee policy)

- Participant is able to ingest oral medication

Exclusion Criteria:

- Current use, or use within 3 months of baseline, of medium-chain
triglyceride-containing products

- Use of any other investigational agent within 60 days prior to screening

- Known allergy or hypersensitivity to milk or soy products

- In the opinion of the investigator, presence or history of advanced, severe,
progressive or unstable disease of any type that could interfere with protocol
assessments or put the participant at particular risk

- Any medical or neurological condition other than Alzheimer's disease that could
explain the patient's dementia

- History or clinical laboratory evidence of moderate congestive heart failure

- Clinically significant ECG abnormalities at screening

- History of new cardiovascular events within 6 months prior to baseline

- History of or current psychiatric illness

- Major depression as determined by Cornell Scale for Depression in Dementia

- Insulin-dependent diabetics

- Systolic blood pressure > 165 mmHg or diastolic blood pressure > 95 mmHg

- Drop of 20 mm Hg systolic blood pressure or greater upon standing upright from a
seated position within 3 minutes at screening

- Clinically significant anemia at screening

- Clinically significant renal disease or insufficiency at screening

- Laboratory values for liver function tests > 2.5 times the upper limit of normal at
screening or history of severe liver disease

- Fasting triglycerides > 2.5 times the upper limit of normal at screening

- Clinically significant B12 deficiency within 12 month prior to screening

- Inflammatory bowel disease or peptic ulcer disease.

- Participants with current or a history of (within the last 5 years) complicated
reflux disease or severe GERD that is not well-controlled by medication.

- Irritable bowel syndrome, diverticular disease (e.g., diverticulosis or
diverticulitis), or chronic gastritis (exclusionary if there has been a diagnosis or
an acute event within 5 years prior to Screening.)

- Has donated ≥ 2 units of blood within the 2 months prior to screening

- History of alcohol or drug abuse within 6 months prior to screening, or positive
urine drug test at screening

- Participant or caregiver is an immediate family member or employee of the clinical
site, sponsor or sponsor's agents

- An alternative cause for dementia other than Alzheimer's disease as determined by a
required CT or MRI scan within 18 months prior to screening

- History of neoplasm or malignancies within 5 years prior to screening, except for
basal cell or squamous cell carcinoma of the skin

- Clinically significant hypothyroidism as determined thyroid function testing at
screening

- Participant has scheduled or expected hospitalization and/or surgery during the
course of the study
We found this trial at
82
sites
?
mi
from
Richmond, VA
Click here to add this to my saved trials
1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
?
mi
from
Atlanta, GA
Click here to add this to my saved trials
175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
?
mi
from
Berlin, NJ
Click here to add this to my saved trials
1000 Alpine
Boulder, Colorado 80304
303-443-7229
?
mi
from
Boulder, CO
Click here to add this to my saved trials
911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
?
mi
from
Hallandale Beach, FL
Click here to add this to my saved trials
1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
?
mi
from
Houston, TX
Click here to add this to my saved trials
1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
?
mi
from
Kalamazoo, MI
Click here to add this to my saved trials
100 West Gore St # 202
Orlando, Florida 32806
(407) 426-9299
Compass Research LLC Compass Research is a clinical research company dedicated to testing new medications...
?
mi
from
Orlando, FL
Click here to add this to my saved trials
2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
3212 Cove Bend Drive
Tampa, Florida 33613
?
mi
from
Tampa, FL
Click here to add this to my saved trials
500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
?
mi
from
Waterbury, CT
Click here to add this to my saved trials
Albuquerque, New Mexico 87109
?
mi
from
Albuquerque, NM
Click here to add this to my saved trials
Austin, Texas 78757
?
mi
from
Austin, TX
Click here to add this to my saved trials
Baltimore, Maryland 21208
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Bellflower, California 90706
?
mi
from
Bellflower, CA
Click here to add this to my saved trials
Beverly Hills, California 90210
?
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
Boca Raton, FL
Click here to add this to my saved trials
Brooklyn, New York 11229
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooklyn, New York 11235
?
mi
from
Brooklyn, NY
Click here to add this to my saved trials
Brooksville, Florida 34601
?
mi
from
Brooksville, FL
Click here to add this to my saved trials
?
mi
from
Canton, OH
Click here to add this to my saved trials
Centennial, Colorado 80112
?
mi
from
Centennial, CO
Click here to add this to my saved trials
Centerville, Ohio 45459
?
mi
from
Centerville, OH
Click here to add this to my saved trials
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
?
mi
from
Charleston, SC
Click here to add this to my saved trials
Charlotte, North Carolina 28204
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Charlotte, North Carolina 28211
?
mi
from
Charlotte, NC
Click here to add this to my saved trials
Cincinnati, Ohio 45227
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Cordova, Tennessee 38018
?
mi
from
Cordova, TN
Click here to add this to my saved trials
Costa Mesa, California 92626
?
mi
from
Costa Mesa, CA
Click here to add this to my saved trials
Dallas, Texas 75214
?
mi
from
Dallas, TX
Click here to add this to my saved trials
Delray Beach, Florida 33445
?
mi
from
Delray Beach, FL
Click here to add this to my saved trials
Denver, Colorado 80218
?
mi
from
Denver, CO
Click here to add this to my saved trials
Downey, California 90241
?
mi
from
Downey, CA
Click here to add this to my saved trials
?
mi
from
Fort Myers, FL
Click here to add this to my saved trials
Franklin, Tennessee 37064
?
mi
from
Franklin, TN
Click here to add this to my saved trials
?
mi
from
Hamden, CT
Click here to add this to my saved trials
Hot Springs, Arkansas 71901
?
mi
from
Hot Springs, AR
Click here to add this to my saved trials
Indianapolis, Indiana 46202
?
mi
from
Indianapolis, IN
Click here to add this to my saved trials
La Jolla, California 92037
?
mi
from
La Jolla, CA
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Laguna Hills, California 92653
?
mi
from
Laguna Hills, CA
Click here to add this to my saved trials
Lake Charles, Louisiana 70601
?
mi
from
Lake Charles, LA
Click here to add this to my saved trials
Lake Worth, Florida 33449
?
mi
from
Lake Worth, FL
Click here to add this to my saved trials
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
Little Rock, Arkansas 72205
?
mi
from
Little Rock, AR
Click here to add this to my saved trials
Long Beach, California 90806
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Long Beach, California 90804
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Long Beach, California 90807
?
mi
from
Long Beach, CA
Click here to add this to my saved trials
Manchester Township, New Jersey 08759
?
mi
from
Manchester Township, NJ
Click here to add this to my saved trials
Manhasset, New York 11030
?
mi
from
Manhasset, NY
Click here to add this to my saved trials
Memphis, Tennessee 38119
?
mi
from
Memphis, TN
Click here to add this to my saved trials
Miami, Florida 33137
?
mi
from
Miami, FL
Click here to add this to my saved trials
Mount Arlington, New Jersey 07856
?
mi
from
Mount Arlington, NJ
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
New York, NY
Click here to add this to my saved trials
New York, New York 10021
?
mi
from
New York, NY
Click here to add this to my saved trials
Oklahoma City, Oklahoma 73103
?
mi
from
Oklahoma City, OK
Click here to add this to my saved trials
?
mi
from
Orangeburg, NY
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19107
?
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Phoenix, Arizona 85006
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Phoenix, Arizona 85050
?
mi
from
Phoenix, AZ
Click here to add this to my saved trials
Portland, Oregon 97210
?
mi
from
Portland, OR
Click here to add this to my saved trials
1402 South Grand Boulevard
Saint Louis, Missouri 63104
?
mi
from
Saint Louis, MO
Click here to add this to my saved trials
Saint Petersburg, Florida 33709
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Saint Petersburg, Florida 33713
?
mi
from
Saint Petersburg, FL
Click here to add this to my saved trials
Salt Lake City, Utah 84107
?
mi
from
Salt Lake City, UT
Click here to add this to my saved trials
San Diego, California 92103
?
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
?
mi
from
San Diego, CA
Click here to add this to my saved trials
Santa Ana, California 92705
?
mi
from
Santa Ana, CA
Click here to add this to my saved trials
Santa Monica, California 90404
?
mi
from
Santa Monica, CA
Click here to add this to my saved trials
Santa Rosa, California 95403
?
mi
from
Santa Rosa, CA
Click here to add this to my saved trials
Sarasota, Florida 34243
?
mi
from
Sarasota, FL
Click here to add this to my saved trials
?
mi
from
Seattle, WA
Click here to add this to my saved trials
Shaker Heights, Ohio 44122
?
mi
from
Shaker Heights, OH
Click here to add this to my saved trials
Somerville, Massachusetts 02145
?
mi
from
Somerville, MA
Click here to add this to my saved trials
Springfield, Massachusetts 01104
?
mi
from
Springfield, MA
Click here to add this to my saved trials
Springfield, New Jersey 07081
?
mi
from
Springfield, NJ
Click here to add this to my saved trials
Toms River, New Jersey 08755
?
mi
from
Toms River, NJ
Click here to add this to my saved trials
West Long Branch, New Jersey 07764
?
mi
from
West Long Branch, NJ
Click here to add this to my saved trials
West Palm Beach, Florida 33407
?
mi
from
West Palm Beach, FL
Click here to add this to my saved trials
Willow Grove, Pennsylvania 19090
?
mi
from
Willow Grove, PA
Click here to add this to my saved trials