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

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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
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Bellflower, California 90706
975
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1100 Johnson Ferry Road
Atlanta, Georgia 30342
404-851-9934
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175 Cross Keys Rd.
Berlin, New Jersey 08009
856-753-7335
2389
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1000 Alpine
Boulder, Colorado 80304
303-443-7229
996
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911 E. Hallandale Beach Blvd
Hallandale Beach, Florida 33009
954-455-5757
2723
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1200 Moursund Street
Houston, Texas 77030
(713) 798-4951
Baylor College of Medicine Baylor College of Medicine in Houston, the only private medical school...
1890
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Houston, TX
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1521 Gull Road Kalamazoo
Kalamazoo, Michigan 49048
269-226-4803
1817
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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...
2547
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Orlando, FL
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2919 Swann Avenue
Tampa, Florida 33609
813-353-9613
2526
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3212 Cove Bend Drive
Tampa, Florida 33613
2522
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500 Chase Parkway
Waterbury, Connecticut 06708
203-419-4420
2418
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Albuquerque, New Mexico 87109
1183
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Austin, Texas 78757
1770
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Baltimore, Maryland 21208
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Beverly Hills, California 90210
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Birmingham, AL
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Brooklyn, New York 11229
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Brooklyn, New York 11235
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Brooksville, Florida 34601
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Canton, OH
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Centennial, Colorado 80112
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Centerville, Ohio 45459
1964
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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...
2422
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Charlotte, North Carolina 28204
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Charlotte, North Carolina 28211
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Cincinnati, Ohio 45227
1971
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Cordova, Tennessee 38018
1875
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Costa Mesa, California 92626
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Dallas, Texas 75214
1680
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Delray Beach, Florida 33445
2702
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Denver, Colorado 80218
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Downey, California 90241
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Fort Myers, FL
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Franklin, Tennessee 37064
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Hamden, CT
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Hot Springs, Arkansas 71901
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Indianapolis, Indiana 46202
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La Jolla, California 92037
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Laguna Hills, California 92653
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Laguna Hills, California 92653
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Lake Charles, Louisiana 70601
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Lake Worth, Florida 33449
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Las Vegas, NV
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Little Rock, Arkansas 72205
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Long Beach, California 90806
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Long Beach, California 90807
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Manchester Township, New Jersey 08759
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Manhasset, New York 11030
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Memphis, Tennessee 38119
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Miami, Florida 33137
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Mount Arlington, New Jersey 07856
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New York, New York 10021
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Oklahoma City, Oklahoma 73103
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Philadelphia, Pennsylvania 19107
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Phoenix, Arizona 85006
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Phoenix, Arizona 85050
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Portland, Oregon 97210
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1402 South Grand Boulevard
Saint Louis, Missouri 63104
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Saint Petersburg, Florida 33709
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Saint Petersburg, Florida 33713
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Salt Lake City, Utah 84107
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San Diego, California 92103
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San Diego, California 92123
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Santa Ana, California 92705
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Santa Monica, California 90404
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Santa Rosa, California 95403
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Sarasota, Florida 34243
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Shaker Heights, Ohio 44122
2028
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Somerville, Massachusetts 02145
2483
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Springfield, Massachusetts 01104
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Springfield, New Jersey 07081
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Toms River, New Jersey 08755
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West Long Branch, New Jersey 07764
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West Palm Beach, Florida 33407
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Willow Grove, Pennsylvania 19090
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