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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT01741194
First received: November 30, 2012
Last updated: April 5, 2016
Last verified: April 2016
  Purpose
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.

Condition Intervention Phase
Alzheimer's Disease
Drug: AC-1204
Drug: Placebo
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Accera, Inc.:

Primary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants


Secondary Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 8 and 17 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 8 and 17 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Quality of Life - Alzheimer's Disease (QoL-AD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(-) participants

  • Incidence of treatment-emergent adverse events [ Time Frame: 26 weeks ] [ Designated as safety issue: Yes ]
    All participants


Other Outcome Measures:
  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Quality of Life - Alzheimer's Disease (QoL- AD) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Mini Mental State Exam (MMSE) [ Time Frame: 26 weeks ] [ Designated as safety issue: No ]
    APOE(+) participants

  • Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Alzheimer's Disease Co-operative Study - Clinical Global Impression of Change (ADCS-CGIC) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Alzheimer's Disease Co-operative Study - Activities of Daily Living (ADCS-ADL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Quality of Life - Alzheimer's Disease (QoL - AD) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Resource Utilization in Dementia (RUD-Lite) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Clock Draw Interpretation Scale (CDIS) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants

  • Ketone body levels (BHB) [ Time Frame: baseline, 8, 17 and 26 weeks ] [ Designated as safety issue: No ]
    All participants

  • Incidence of treatment-emergent adverse events [ Time Frame: 52 weeks ] [ Designated as safety issue: Yes ]
    All participants

  • Mini Mental State Exam (MMSE) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
    All participants


Enrollment: 418
Study Start Date: March 2013
Estimated Study Completion Date: October 2017
Estimated Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   66 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01741194

  Hide Study Locations
Locations
United States, Alabama
University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
HOPE Research Institute
Phoenix, Arizona, United States, 85018
United States, Arkansas
Principals Research Group
Hot Springs, Arkansas, United States, 71901
Clinical Trials, Inc.
Little Rock, Arkansas, United States, 72205
United States, California
CITrials, Inc.
Bellflower, California, United States, 90706
Southern Research LLC
Beverly Hills, California, United States, 90210
ATP Clinical Research, Inc.
Costa Mesa, California, United States, 92626
Diligent Clinical Trials
Downey, California, United States, 90241
UCSD Comprehensive Alzheimer's Program
La Jolla, California, United States, 92037
Alliance Research Centers
Laguna Hills, California, United States, 92653
Senior Clinical Trials, Inc.
Laguna Hills, California, United States, 92653
Collaborative Neuroscience Network
Long Beach, California, United States, 90806
Alliance for Research
Long Beach, California, United States, 90807
Renew Behavioral Health
Long Beach, California, United States, 90807
Pacific Research Network
San Diego, California, United States, 92103
Artemis Institute for Clinical Research
San Diego, California, United States, 92123
Research Across America
Santa Ana, California, United States, 92705
Neurological Research Institute
Santa Monica, California, United States, 90404
Redwood Research Medical Group
Santa Rosa, California, United States, 95403
United States, Colorado
Alpine Clinical Research Center
Boulder, Colorado, United States, 80304
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
The Mile High Research Center
Denver, Colorado, United States, 80218
United States, Connecticut
Chase Medical Research of Greater New Haven
Hamden, Connecticut, United States, 06517
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton, Florida, United States, 33486
Meridian Research
Brooksville, Florida, United States, 34601
Brain Matters Research
Delray Beach, Florida, United States, 33445
Neuropsychiatric Research Center of Southwest Florida
Fort Meyers, Florida, United States, 33912
MD Clinical
Hallandale Beach, Florida, United States, 33009
Alzheimer's Research and Treatment Center
Lake Worth, Florida, United States, 33449
Miami Jewish Health Systems
Miami, Florida, United States, 33137
Compass Research, LLC
Orlando, Florida, United States, 32806
Suncoast Neuroscience Associates
Petersburg, Florida, United States, 33713
The Roskamp Institute
Sarasota, Florida, United States, 34243
Meridien Research
St. Petersburg, Florida, United States, 33709
Axiom Clinical Research of Florida
Tampa, Florida, United States, 33609
Stedman Clinical Trials
Tampa, Florida, United States, 33613
Premiere Research Institute
West Palm Beach, Florida, United States, 33407
United States, Georgia
NeuroTrials Research, Inc
Atlanta, Georgia, United States, 30342
United States, Indiana
IU Health Partners Adult Neurology Clinic
Indianapolis, Indiana, United States, 46202
United States, Louisiana
Lake Charles Clinical Trials
Lake Charles, Louisiana, United States, 70629
United States, Maryland
Pharmasite Research, Inc.
Baltimore, Maryland, United States, 21208
United States, Massachusetts
Alzheimers Disease Center, Quincy Medical Center
Somerville, Massachusetts, United States, 02169
Springfield Neurology Associates
Springfield, Massachusetts, United States, 01104
United States, Michigan
Borgess Research Institute
Kalamazoo, Michigan, United States, 49048
United States, Missouri
Saint Louis University Medical School /Department of Neurology & Psychiatry
St. Louis, Missouri, United States, 63104
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Comprehensive Clinical Research
Berlin, New Jersey, United States, 08009
Alzheimer's Research Corporation
Manchester, New Jersey, United States, 08759
NeuroCognitive Institute
Mt. Arlington, New Jersey, United States, 07856
The Cognitive Research Center of New Jersey
Springfield, New Jersey, United States, 07081
Memory Enhancement Center of NJ
Toms River, New Jersey, United States, 08755
Neurology Specialists of Monmouth County
West Long Branch, New Jersey, United States, 07764
United States, New Mexico
Albuquerque Neuroscience, Inc.
Albuquerque, New Mexico, United States, 87109
United States, New York
Integrative Clinical Trials, LLC
Brooklyn, New York, United States, 11229
SPRI Clinical Trials, LLC
Brooklyn, New York, United States, 11235
The Litwin-Zucker Research Center
Manhasset, New York, United States, 11030
Parker Jewish Institute For Health Care & Rehabilitation
New Hyde Park, New York, United States, 11040
NYU Langone Medical Center Comprehensive Center on Brain Aging
New York, New York, United States, 10016
Eastside Comprehensive Medical Center, LLC
New York, New York, United States, 10021
Nathan S. Kline Institute Geriatric Psychiatry Program
Orangeburg, New York, United States, 10962
United States, North Carolina
Ani Neurology, PLLC dba Alzheimer's Memory Ctr
Charlotte, North Carolina, United States, 28211
New Hope Clinical Research
Charlotte, North Carolina, United States, 28204
United States, Ohio
Neuro-Behavioral Clinical Research, Inc.
Canton, Ohio, United States, 44718
Valley Medical Research
Centerville, Ohio, United States, 45459
CTI Clinical Research Center
Cincinnati, Ohio, United States, 45227
Insight Clinical Trials LLC
Shaker Heights, Ohio, United States, 44122
United States, Oklahoma
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
United States, Oregon
Summit Research Network (Oregon) Inc.
Portland, Oregon, United States, 97210
United States, Pennsylvania
Drexel Neurological Associates
Philadelphia, Pennsylvania, United States, 19107
Abington Neurological Associates
Willow Grove, Pennsylvania, United States, 19090
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29406
United States, Tennessee
Neurology Clinic, P.C.
Cordova, Tennessee, United States, 38018
Clinical Research Solutions
Franklin, Tennessee, United States, 37064
Clinical Neuroscience Solutions, Inc
Memphis, Tennessee, United States, 38119
United States, Texas
Senior Adults Specialty Research, Inc
Austin, Texas, United States, 78757
Texas Neurology
Dallas, Texas, United States, 75214
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Utah
Wasatch Clinical Research
Salt Lake City, Utah, United States, 84107
United States, Virginia
National Clinical Research - Richmond, Inc.
Richmond, Virginia, United States, 23294
United States, Washington
VA Puget Sound-Alzhemier's Disease Research Center
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Samuel T Henderson, PhD Accera, Inc.
  More Information

Additional Information:
Responsible Party: Accera, Inc.
ClinicalTrials.gov Identifier: NCT01741194     History of Changes
Other Study ID Numbers: AC-12-010 
Study First Received: November 30, 2012
Last Updated: April 5, 2016
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on May 04, 2016