AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext
NCT ID: NCT01741194
Last Updated: 2021-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
418 participants
INTERVENTIONAL
2013-03-31
2017-04-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
QUADRUPLE
Study Groups
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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.
AC-1204
AC-1204 taken once daily, by mouth
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.
Placebo
Placebo taken once daily, by mouth
Interventions
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AC-1204
AC-1204 taken once daily, by mouth
Placebo
Placebo taken once daily, by mouth
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
66 Years
90 Years
ALL
No
Sponsors
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Cerecin
INDUSTRY
Responsible Party
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Principal Investigators
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Samuel T Henderson, PhD
Role: STUDY_DIRECTOR
Cerecin
Locations
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University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
Birmingham, Alabama, United States
Banner Alzheimer's Institute
Phoenix, Arizona, United States
HOPE Research Institute
Phoenix, Arizona, United States
Principals Research Group
Hot Springs, Arkansas, United States
Clinical Trials, Inc.
Little Rock, Arkansas, United States
CITrials, Inc.
Bellflower, California, United States
Southern Research LLC
Beverly Hills, California, United States
ATP Clinical Research, Inc.
Costa Mesa, California, United States
Diligent Clinical Trials
Downey, California, United States
UCSD Comprehensive Alzheimer's Program
La Jolla, California, United States
Alliance Research Centers
Laguna Hills, California, United States
Senior Clinical Trials, Inc.
Laguna Hills, California, United States
Collaborative Neuroscience Network
Long Beach, California, United States
Alliance for Research
Long Beach, California, United States
Renew Behavioral Health
Long Beach, California, United States
Pacific Research Network
San Diego, California, United States
Artemis Institute for Clinical Research
San Diego, California, United States
Research Across America
Santa Ana, California, United States
Neurological Research Institute
Santa Monica, California, United States
Redwood Research Medical Group
Santa Rosa, California, United States
Alpine Clinical Research Center
Boulder, Colorado, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
The Mile High Research Center
Denver, Colorado, United States
Chase Medical Research of Greater New Haven
Hamden, Connecticut, United States
Chase Medical Research, LLC
Waterbury, Connecticut, United States
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States
Meridian Research
Brooksville, Florida, United States
Brain Matters Research
Delray Beach, Florida, United States
Neuropsychiatric Research Center of Southwest Florida
Fort Myers, Florida, United States
MD Clinical
Hallandale, Florida, United States
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States
Miami Jewish Health Systems
Miami, Florida, United States
Compass Research, LLC
Orlando, Florida, United States
The Roskamp Institute
Sarasota, Florida, United States
Meridien Research
St. Petersburg, Florida, United States
Suncoast Neuroscience Associates
St. Petersburg, Florida, United States
Axiom Clinical Research of Florida
Tampa, Florida, United States
Stedman Clinical Trials
Tampa, Florida, United States
Premiere Research Institute
West Palm Beach, Florida, United States
NeuroTrials Research, Inc
Atlanta, Georgia, United States
IU Health Partners Adult Neurology Clinic
Indianapolis, Indiana, United States
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States
Pharmasite Research, Inc.
Baltimore, Maryland, United States
Alzheimers Disease Center, Quincy Medical Center
Somerville, Massachusetts, United States
Springfield Neurology Associates
Springfield, Massachusetts, United States
Borgess Research Institute
Kalamazoo, Michigan, United States
Saint Louis University Medical School /Department of Neurology & Psychiatry
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States
Comprehensive Clinical Research
Berlin, New Jersey, United States
NeuroCognitive Institute
Mount Arlington, New Jersey, United States
Alzheimer's Research Corporation
Paterson, 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
Neurology Specialists of Monmouth County
West Long Branch, 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
The Litwin-Zucker Research Center
Manhasset, New York, United States
Parker Jewish Institute For Health Care & Rehabilitation
New Hyde Park, New York, United States
NYU Langone Medical Center Comprehensive Center on Brain Aging
New York, New York, United States
Eastside Comprehensive Medical Center, LLC
New York, New York, United States
Nathan S. Kline Institute Geriatric Psychiatry Program
Orangeburg, New York, United States
New Hope Clinical Research
Charlotte, North Carolina, United States
Ani Neurology, PLLC dba Alzheimer's Memory Ctr
Charlotte, North Carolina, United States
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States
Valley Medical Research
Centerville, Ohio, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Insight Clinical Trials LLC
Shaker Heights, Ohio, United States
IPS Research Company
Oklahoma City, Oklahoma, United States
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States
Drexel Neurological Associates
Philadelphia, Pennsylvania, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Neurology Clinic, P.C.
Cordova, Tennessee, United States
Clinical Research Solutions
Franklin, Tennessee, United States
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States
Senior Adults Specialty Research, Inc
Austin, Texas, United States
Texas Neurology
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Wasatch Clinical Research
Salt Lake City, Utah, United States
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States
VA Puget Sound-Alzhemier's Disease Research Center
Seattle, Washington, United States
Countries
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References
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Henderson ST, Morimoto BH, Cummings JL, Farlow MR, Walker J. A Placebo-Controlled, Parallel-Group, Randomized Clinical Trial of AC-1204 in Mild-to-Moderate Alzheimer's Disease. J Alzheimers Dis. 2020;75(2):547-557. doi: 10.3233/JAD-191302.
Related Links
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Alzheimer's Survey
Other Identifiers
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AC-12-010
Identifier Type: -
Identifier Source: org_study_id
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