AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext
- Registration Number
- NCT01741194
- Lead Sponsor
- Cerecin
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 418
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo is an isocaloric formulation prepared to be virtually identical to AC-1204 in appearance, odor and taste. Powdered formulation is mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed. AC-1204 AC-1204 Powder formulation (40 g) mixed with 4-8 ounces of water, other liquid or soft food as preferred, and shaken or blended until fully mixed. Each dosing unit of AC-1204 contains 20 g of the active ingredient, caprylic triglyceride.
- Primary Outcome Measures
Name Time Method Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 26 weeks APOE(-) participants
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events 26 weeks All participants
Clock Draw Interpretation Scale (CDIS) 8 and 17 weeks APOE(-) participants
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) 26 weeks APOE(-) participants
Quality of Life - Alzheimer's Disease (QoL-AD) 26 weeks APOE(-) participants
Resource Utilization in Dementia (RUD-Lite) 26 weeks APOE(-) participants
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) 8 and 17 weeks APOE(-) participants
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) 26 weeks APOE(-) participants
Trial Locations
- Locations (82)
Brain Matters Research
🇺🇸Delray Beach, Florida, United States
NeuroTrials Research, Inc
🇺🇸Atlanta, Georgia, United States
Pharmasite Research, Inc.
🇺🇸Baltimore, Maryland, United States
Miami Jewish Health Systems
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
VA Puget Sound-Alzhemier's Disease Research Center
🇺🇸Seattle, Washington, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Artemis Institute for Clinical Research
🇺🇸San Diego, California, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
🇺🇸Las Vegas, Nevada, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
CITrials, Inc.
🇺🇸Bellflower, California, United States
Diligent Clinical Trials
🇺🇸Downey, California, United States
Renew Behavioral Health
🇺🇸Long Beach, California, United States
Alliance Research Centers
🇺🇸Laguna Hills, California, United States
Alliance for Research
🇺🇸Long Beach, California, United States
Principals Research Group
🇺🇸Hot Springs, Arkansas, United States
UCSD Comprehensive Alzheimer's Program
🇺🇸La Jolla, California, United States
Suncoast Neuroscience Associates
🇺🇸Saint Petersburg, Florida, United States
ATP Clinical Research, Inc.
🇺🇸Costa Mesa, California, United States
Southern Research LLC
🇺🇸Beverly Hills, California, United States
Meridian Research
🇺🇸Brooksville, Florida, United States
MD Clinical
🇺🇸Hallandale Beach, Florida, United States
Senior Clinical Trials, Inc.
🇺🇸Laguna Hills, California, United States
Collaborative Neuroscience Network
🇺🇸Long Beach, California, United States
Clinical Trials, Inc.
🇺🇸Little Rock, Arkansas, United States
Meridien Research
🇺🇸Saint Petersburg, Florida, United States
Banner Alzheimer's Institute
🇺🇸Phoenix, Arizona, United States
HOPE Research Institute
🇺🇸Phoenix, Arizona, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Wasatch Clinical Research
🇺🇸Salt Lake City, Utah, United States
University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
🇺🇸Birmingham, Alabama, United States
The Mile High Research Center
🇺🇸Denver, Colorado, United States
Summit Research Network (Oregon) Inc.
🇺🇸Portland, Oregon, United States
The Litwin-Zucker Research Center
🇺🇸Manhasset, New York, United States
IMMUNOe Research Centers
🇺🇸Centennial, Colorado, United States
Neurological Research Institute
🇺🇸Santa Monica, California, United States
Redwood Research Medical Group
🇺🇸Santa Rosa, California, United States
Research Across America
🇺🇸Santa Ana, California, United States
Alpine Clinical Research Center
🇺🇸Boulder, Colorado, United States
Premiere Research Institute
🇺🇸West Palm Beach, Florida, United States
Chase Medical Research of Greater New Haven
🇺🇸Hamden, Connecticut, United States
Alzheimer's Research and Treatment Center
🇺🇸Lake Worth, Florida, United States
Chase Medical Research, LLC
🇺🇸Waterbury, Connecticut, United States
The Roskamp Institute
🇺🇸Sarasota, Florida, United States
Ani Neurology, PLLC dba Alzheimer's Memory Ctr
🇺🇸Charlotte, North Carolina, United States
Alzheimer's Research Corporation
🇺🇸Manchester, New Jersey, United States
Texas Neurology
🇺🇸Dallas, Texas, United States
Parker Jewish Institute For Health Care & Rehabilitation
🇺🇸New Hyde Park, New York, United States
Abington Neurological Associates
🇺🇸Willow Grove, Pennsylvania, United States
Clinical Research Solutions
🇺🇸Franklin, Tennessee, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
🇺🇸Boca Raton, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
🇺🇸Fort Myers, Florida, United States
IU Health Partners Adult Neurology Clinic
🇺🇸Indianapolis, Indiana, United States
Lake Charles Clinical Trials
🇺🇸Lake Charles, Louisiana, United States
Borgess Research Institute
🇺🇸Kalamazoo, Michigan, United States
Alzheimers Disease Center, Quincy Medical Center
🇺🇸Somerville, Massachusetts, United States
Springfield Neurology Associates
🇺🇸Springfield, Massachusetts, United States
Comprehensive Clinical Research
🇺🇸Berlin, New Jersey, United States
Saint Louis University Medical School /Department of Neurology & Psychiatry
🇺🇸Saint Louis, Missouri, United States
Neurology Specialists of Monmouth County
🇺🇸West Long Branch, New Jersey, United States
NeuroCognitive Institute
🇺🇸Mount Arlington, New Jersey, United States
The Cognitive Research Center of New Jersey
🇺🇸Springfield, New Jersey, United States
Memory Enhancement Center of NJ
🇺🇸Toms River, New Jersey, United States
Albuquerque Neuroscience, Inc.
🇺🇸Albuquerque, New Mexico, United States
Integrative Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
SPRI Clinical Trials, LLC
🇺🇸Brooklyn, New York, United States
Eastside Comprehensive Medical Center, LLC
🇺🇸New York, New York, United States
New Hope Clinical Research
🇺🇸Charlotte, North Carolina, United States
NYU Langone Medical Center Comprehensive Center on Brain Aging
🇺🇸New York, New York, United States
Nathan S. Kline Institute Geriatric Psychiatry Program
🇺🇸Orangeburg, New York, United States
Neuro-Behavioral Clinical Research, Inc.
🇺🇸Canton, Ohio, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Insight Clinical Trials LLC
🇺🇸Shaker Heights, Ohio, United States
Drexel Neurological Associates
🇺🇸Philadelphia, Pennsylvania, United States
Neurology Clinic, P.C.
🇺🇸Cordova, Tennessee, United States
Clinical Neuroscience Solutions, Inc
🇺🇸Memphis, Tennessee, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Axiom Clinical Research of Florida
🇺🇸Tampa, Florida, United States
Stedman Clinical Trials
🇺🇸Tampa, Florida, United States
Senior Adults Specialty Research, Inc
🇺🇸Austin, Texas, United States
National Clinical Research - Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States