AC-1204 26-Week Long Term Efficacy Response Trial With Optional Open-label Ext (NOURISH-AD)

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: Alzheimer's Disease
• Intervention / Treatment: Drug: AC-1204; Drug: Placebo

• Study Type: Interventional
• Enrollment (Actual): 418
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Banner Alzheimer's Institute
    • Phoenix, Arizona, United States, 85018
      • Hope Research Institute
  • Arkansas
    • Hot Springs, Arkansas, United States, 71901
      • Principals Research Group
    • Little Rock, Arkansas, United States, 72205
      • Clinical Trials, Inc.
  • California
    • Bellflower, California, United States, 90706
      • CITrials, Inc.
    • Beverly Hills, California, United States, 90210
      • Southern Research LLC
    • Costa Mesa, California, United States, 92626
      • ATP Clinical Research, Inc.
    • Downey, California, United States, 90241
      • Diligent Clinical Trials
    • La Jolla, California, United States, 92037
      • UCSD Comprehensive Alzheimer's Program
    • Laguna Hills, California, United States, 92653
      • Senior Clinical Trials, Inc.
    • Laguna Hills, California, United States, 92653
      • Alliance Research Centers
    • Long Beach, California, United States, 90806
      • Collaborative NeuroScience Network
    • Long Beach, California, United States, 90807
      • Alliance for Research
    • Long Beach, California, United States, 90807
      • Renew Behavioral Health
    • San Diego, California, United States, 92103
      • Pacific Research Network
    • San Diego, California, United States, 92123
      • Artemis Institute for Clinical Research
    • Santa Ana, California, United States, 92705
      • Research Across America
    • Santa Monica, California, United States, 90404
      • Neurological Research Institute
    • Santa Rosa, California, United States, 95403
      • Redwood Research Medical Group
  • Colorado
    • Boulder, Colorado, United States, 80304
      • Alpine Clinical Research Center
    • Centennial, Colorado, United States, 80112
      • IMMUNOe Research Centers
    • Denver, Colorado, United States, 80218
      • The Mile High Research Center
  • Connecticut
    • Hamden, Connecticut, United States, 06517
      • Chase Medical Research of Greater New Haven
    • Waterbury, Connecticut, United States, 06708
      • Chase Medical Research, LLC
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Parkinson's Disease and Movement Disorders Center of Boca Raton
    • Brooksville, Florida, United States, 34601
      • Meridian Research
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Fort Myers, Florida, United States, 33912
      • Neuropsychiatric Research Center of Southwest Florida
    • Hallandale Beach, Florida, United States, 33009
      • MD Clinical
    • Lake Worth, Florida, United States, 33449
      • Alzheimer's Research and Treatment Center
    • Miami, Florida, United States, 33137
      • Miami Jewish Health Systems
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Saint Petersburg, Florida, United States, 33709
      • Meridien Research
    • Saint Petersburg, Florida, United States, 33713
      • Suncoast Neuroscience Associates
    • Sarasota, Florida, United States, 34243
      • The Roskamp Institute
    • Tampa, Florida, United States, 33609
      • Axiom Clinical Research of Florida
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • West Palm Beach, Florida, United States, 33407
      • Premiere Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30342
      • Neurotrials Research, Inc
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • IU Health Partners Adult Neurology Clinic
  • Louisiana
    • Lake Charles, Louisiana, United States, 70629
      • Lake Charles Clinical Trials
  • Maryland
    • Baltimore, Maryland, United States, 21208
      • Pharmasite Research, Inc.
  • Massachusetts
    • Somerville, Massachusetts, United States, 02169
      • Alzheimers Disease Center, Quincy Medical Center
    • Springfield, Massachusetts, United States, 01104
      • Springfield Neurology Associates
  • Michigan
    • Kalamazoo, Michigan, United States, 49048
      • Borgess Research Institute
  • Missouri
    • Saint Louis, Missouri, United States, 63104
      • Saint Louis University Medical School /Department of Neurology & Psychiatry
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Cleveland Clinic Lou Ruvo Center for Brain Health
  • New Jersey
    • Berlin, New Jersey, United States, 08009
      • Comprehensive Clinical Research
    • Manchester, New Jersey, United States, 08759
      • Alzheimer's Research Corporation
    • Mount Arlington, New Jersey, United States, 07856
      • NeuroCognitive Institute
    • Springfield, New Jersey, United States, 07081
      • The Cognitive Research Center of New Jersey
    • Toms River, New Jersey, United States, 08755
      • Memory Enhancement Center of NJ
    • West Long Branch, New Jersey, United States, 07764
      • Neurology Specialists of Monmouth County
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Albuquerque Neuroscience, Inc.
  • New York
    • Brooklyn, New York, United States, 11229
      • Integrative Clinical Trials, LLC
    • Brooklyn, New York, United States, 11235
      • SPRI Clinical Trials, LLC
    • Manhasset, New York, United States, 11030
      • The Litwin-Zucker Research Center
    • New Hyde Park, New York, United States, 11040
      • Parker Jewish Institute for Health Care & Rehabilitation
    • New York, New York, United States, 10021
      • Eastside Comprehensive Medical Center, LLC
    • New York, New York, United States, 10016
      • NYU Langone Medical Center Comprehensive Center on Brain Aging
    • Orangeburg, New York, United States, 10962
      • Nathan S. Kline Institute Geriatric Psychiatry Program
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • New Hope Clinical Research
    • Charlotte, North Carolina, United States, 28211
      • Ani Neurology, PLLC dba Alzheimer's Memory Ctr
  • Ohio
    • Canton, Ohio, United States, 44718
      • Neuro-Behavioral Clinical Research, Inc.
    • Centerville, Ohio, United States, 45459
      • Valley Medical Research
    • Cincinnati, Ohio, United States, 45227
      • CTI Clinical Research Center
    • Shaker Heights, Ohio, United States, 44122
      • Insight Clinical Trials LLC
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research Company
  • Oregon
    • Portland, Oregon, United States, 97210
      • Summit Research Network (Oregon) Inc.
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Drexel Neurological Associates
    • Willow Grove, Pennsylvania, United States, 19090
      • Abington Neurological Associates
  • South Carolina
    • Charleston, South Carolina, United States, 29406
      • Medical University of South Carolina
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic, P.C.
    • Franklin, Tennessee, United States, 37064
      • Clinical Research Solutions
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc
  • Texas
    • Austin, Texas, United States, 78757
      • Senior Adults Specialty Research, Inc
    • Dallas, Texas, United States, 75214
      • Texas Neurology
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Wasatch Clinical Research
  • Virginia
    • Richmond, Virginia, United States, 23294
      • National Clinical Research - Richmond, Inc.
  • Washington
    • Seattle, Washington, United States, 98108
      • VA Puget Sound-Alzhemier's Disease Research Center

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

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.	Drug: AC-1204; AC-1204 taken once daily, by mouth
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.	Drug: Placebo; Placebo taken once daily, by mouth

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	APOE(-) participants	26 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	APOE(-) participants	8 and 17 weeks
Clock Draw Interpretation Scale (CDIS)	APOE(-) participants	8 and 17 weeks
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)	APOE(-) participants	26 weeks
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)	APOE(-) participants	26 weeks
Quality of Life - Alzheimer's Disease (QoL-AD)	APOE(-) participants	26 weeks
Resource Utilization in Dementia (RUD-Lite)	APOE(-) participants	26 weeks
Incidence of treatment-emergent adverse events	All participants	26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	APOE(+) participants	26 weeks
Clock Draw Interpretation Scale (CDIS)	APOE(+) participants	26 weeks
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)	APOE(+) participants	26 weeks
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)	APOE(+) participants	26 weeks
Quality of Life - Alzheimer's Disease (QoL- AD)	APOE(+) participants	26 weeks
Resource Utilization in Dementia (RUD-Lite)	APOE(+) participants	26 weeks
Mini Mental State Exam (MMSE)	APOE(+) participants	26 weeks
Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog)	All participants	52 weeks
Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC)	All participants	52 weeks
Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL)	All participants	52 weeks
Quality of Life - Alzheimer's Disease (QoL - AD)	All participants	52 weeks
Resource Utilization in Dementia (RUD-Lite)	All participants	52 weeks
Clock Draw Interpretation Scale (CDIS)	All participants	52 weeks
Ketone body levels (BHB)	All participants	baseline, 8, 17 and 26 weeks
Incidence of treatment-emergent adverse events	All participants	52 weeks
Mini Mental State Exam (MMSE)	All participants	52 weeks

Collaborators and Investigators

• Sponsor: Cerecin
• Investigators: Study Director: Samuel T Henderson, PhD, Cerecin

Publications and helpful links

General Publications

• 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.

Helpful Links

• Alzheimer's Survey

Study record dates

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: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease
• Other Study ID Numbers: AC-12-010