- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01741194
AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext (NOURISH-AD)
July 30, 2021 updated by: Cerecin
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
418
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35294
- University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
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Arizona
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Phoenix, Arizona, United States, 85006
- Banner Alzheimer's Institute
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Phoenix, Arizona, United States, 85018
- Hope Research Institute
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Arkansas
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Hot Springs, Arkansas, United States, 71901
- Principals Research Group
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Little Rock, Arkansas, United States, 72205
- Clinical Trials, Inc.
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California
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Bellflower, California, United States, 90706
- CITrials, Inc.
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Beverly Hills, California, United States, 90210
- Southern Research LLC
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Costa Mesa, California, United States, 92626
- ATP Clinical Research, Inc.
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Downey, California, United States, 90241
- Diligent Clinical Trials
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La Jolla, California, United States, 92037
- UCSD Comprehensive Alzheimer's Program
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Laguna Hills, California, United States, 92653
- Senior Clinical Trials, Inc.
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Laguna Hills, California, United States, 92653
- Alliance Research Centers
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Long Beach, California, United States, 90806
- Collaborative NeuroScience Network
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Long Beach, California, United States, 90807
- Alliance for Research
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Long Beach, California, United States, 90807
- Renew Behavioral Health
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San Diego, California, United States, 92103
- Pacific Research Network
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San Diego, California, United States, 92123
- Artemis Institute for Clinical Research
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Santa Ana, California, United States, 92705
- Research Across America
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Santa Monica, California, United States, 90404
- Neurological Research Institute
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Santa Rosa, California, United States, 95403
- Redwood Research Medical Group
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Colorado
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Boulder, Colorado, United States, 80304
- Alpine Clinical Research Center
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Centennial, Colorado, United States, 80112
- IMMUNOe Research Centers
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Denver, Colorado, United States, 80218
- The Mile High Research Center
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Connecticut
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Hamden, Connecticut, United States, 06517
- Chase Medical Research of Greater New Haven
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Waterbury, Connecticut, United States, 06708
- Chase Medical Research, LLC
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Florida
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Boca Raton, Florida, United States, 33486
- Parkinson's Disease and Movement Disorders Center of Boca Raton
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Brooksville, Florida, United States, 34601
- Meridian Research
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Delray Beach, Florida, United States, 33445
- Brain Matters Research
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Fort Myers, Florida, United States, 33912
- Neuropsychiatric Research Center of Southwest Florida
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Hallandale Beach, Florida, United States, 33009
- MD Clinical
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Lake Worth, Florida, United States, 33449
- Alzheimer's Research and Treatment Center
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Miami, Florida, United States, 33137
- Miami Jewish Health Systems
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Orlando, Florida, United States, 32806
- Compass Research, LLC
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Saint Petersburg, Florida, United States, 33709
- Meridien Research
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Saint Petersburg, Florida, United States, 33713
- Suncoast Neuroscience Associates
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Sarasota, Florida, United States, 34243
- The Roskamp Institute
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Tampa, Florida, United States, 33609
- Axiom Clinical Research of Florida
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Tampa, Florida, United States, 33613
- Stedman Clinical Trials
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West Palm Beach, Florida, United States, 33407
- Premiere Research Institute
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Georgia
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Atlanta, Georgia, United States, 30342
- Neurotrials Research, Inc
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Indiana
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Indianapolis, Indiana, United States, 46202
- IU Health Partners Adult Neurology Clinic
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Louisiana
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Lake Charles, Louisiana, United States, 70629
- Lake Charles Clinical Trials
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Maryland
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Baltimore, Maryland, United States, 21208
- Pharmasite Research, Inc.
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Massachusetts
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Somerville, Massachusetts, United States, 02169
- Alzheimers Disease Center, Quincy Medical Center
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Springfield, Massachusetts, United States, 01104
- Springfield Neurology Associates
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Michigan
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Kalamazoo, Michigan, United States, 49048
- Borgess Research Institute
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Missouri
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Saint Louis, Missouri, United States, 63104
- Saint Louis University Medical School /Department of Neurology & Psychiatry
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Nevada
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Las Vegas, Nevada, United States, 89106
- Cleveland Clinic Lou Ruvo Center for Brain Health
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New Jersey
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Berlin, New Jersey, United States, 08009
- Comprehensive Clinical Research
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Manchester, New Jersey, United States, 08759
- Alzheimer's Research Corporation
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Mount Arlington, New Jersey, United States, 07856
- NeuroCognitive Institute
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Springfield, New Jersey, United States, 07081
- The Cognitive Research Center of New Jersey
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Toms River, New Jersey, United States, 08755
- Memory Enhancement Center of NJ
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West Long Branch, New Jersey, United States, 07764
- Neurology Specialists of Monmouth County
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New Mexico
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Albuquerque, New Mexico, United States, 87109
- Albuquerque Neuroscience, Inc.
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New York
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Brooklyn, New York, United States, 11229
- Integrative Clinical Trials, LLC
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Brooklyn, New York, United States, 11235
- SPRI Clinical Trials, LLC
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Manhasset, New York, United States, 11030
- The Litwin-Zucker Research Center
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New Hyde Park, New York, United States, 11040
- Parker Jewish Institute for Health Care & Rehabilitation
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New York, New York, United States, 10021
- Eastside Comprehensive Medical Center, LLC
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New York, New York, United States, 10016
- NYU Langone Medical Center Comprehensive Center on Brain Aging
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Orangeburg, New York, United States, 10962
- Nathan S. Kline Institute Geriatric Psychiatry Program
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North Carolina
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Charlotte, North Carolina, United States, 28204
- New Hope Clinical Research
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Charlotte, North Carolina, United States, 28211
- Ani Neurology, PLLC dba Alzheimer's Memory Ctr
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Ohio
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Canton, Ohio, United States, 44718
- Neuro-Behavioral Clinical Research, Inc.
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Centerville, Ohio, United States, 45459
- Valley Medical Research
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Cincinnati, Ohio, United States, 45227
- CTI Clinical Research Center
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Shaker Heights, Ohio, United States, 44122
- Insight Clinical Trials LLC
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73103
- IPS Research Company
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Oregon
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Portland, Oregon, United States, 97210
- Summit Research Network (Oregon) Inc.
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Drexel Neurological Associates
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Willow Grove, Pennsylvania, United States, 19090
- Abington Neurological Associates
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South Carolina
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Charleston, South Carolina, United States, 29406
- Medical University of South Carolina
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Tennessee
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Cordova, Tennessee, United States, 38018
- Neurology Clinic, P.C.
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Franklin, Tennessee, United States, 37064
- Clinical Research Solutions
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Memphis, Tennessee, United States, 38119
- Clinical Neuroscience Solutions, Inc
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Texas
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Austin, Texas, United States, 78757
- Senior Adults Specialty Research, Inc
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Dallas, Texas, United States, 75214
- Texas Neurology
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Houston, Texas, United States, 77030
- Baylor College of Medicine
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Utah
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Salt Lake City, Utah, United States, 84107
- Wasatch Clinical Research
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Virginia
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Richmond, Virginia, United States, 23294
- National Clinical Research - Richmond, Inc.
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Washington
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Seattle, Washington, United States, 98108
- VA Puget Sound-Alzhemier's Disease Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
66 years to 90 years (OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
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AC-1204 taken once daily, by mouth
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PLACEBO_COMPARATOR: 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.
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Placebo taken once daily, by mouth
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: 26 weeks
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APOE(-) participants
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26 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: 8 and 17 weeks
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APOE(-) participants
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8 and 17 weeks
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Clock Draw Interpretation Scale (CDIS)
Time Frame: 8 and 17 weeks
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APOE(-) participants
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8 and 17 weeks
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Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time Frame: 26 weeks
|
APOE(-) participants
|
26 weeks
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Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 26 weeks
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APOE(-) participants
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26 weeks
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Quality of Life - Alzheimer's Disease (QoL-AD)
Time Frame: 26 weeks
|
APOE(-) participants
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26 weeks
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Resource Utilization in Dementia (RUD-Lite)
Time Frame: 26 weeks
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APOE(-) participants
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26 weeks
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Incidence of treatment-emergent adverse events
Time Frame: 26 weeks
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All participants
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26 weeks
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: 26 weeks
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APOE(+) participants
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26 weeks
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Clock Draw Interpretation Scale (CDIS)
Time Frame: 26 weeks
|
APOE(+) participants
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26 weeks
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Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time Frame: 26 weeks
|
APOE(+) participants
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26 weeks
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Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 26 weeks
|
APOE(+) participants
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26 weeks
|
Quality of Life - Alzheimer's Disease (QoL- AD)
Time Frame: 26 weeks
|
APOE(+) participants
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26 weeks
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Resource Utilization in Dementia (RUD-Lite)
Time Frame: 26 weeks
|
APOE(+) participants
|
26 weeks
|
Mini Mental State Exam (MMSE)
Time Frame: 26 weeks
|
APOE(+) participants
|
26 weeks
|
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Quality of Life - Alzheimer's Disease (QoL - AD)
Time Frame: 52 weeks
|
All participants
|
52 weeks
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Resource Utilization in Dementia (RUD-Lite)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Clock Draw Interpretation Scale (CDIS)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Ketone body levels (BHB)
Time Frame: baseline, 8, 17 and 26 weeks
|
All participants
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baseline, 8, 17 and 26 weeks
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Incidence of treatment-emergent adverse events
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Mini Mental State Exam (MMSE)
Time Frame: 52 weeks
|
All participants
|
52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Samuel T Henderson, PhD, Cerecin
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2013
Primary Completion (ACTUAL)
October 24, 2016
Study Completion (ACTUAL)
April 14, 2017
Study Registration Dates
First Submitted
November 30, 2012
First Submitted That Met QC Criteria
November 30, 2012
First Posted (ESTIMATE)
December 4, 2012
Study Record Updates
Last Update Posted (ACTUAL)
August 2, 2021
Last Update Submitted That Met QC Criteria
July 30, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AC-12-010
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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