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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2015 by Accera, Inc.
Information provided by (Responsible Party):
Accera, Inc. Identifier:
First received: November 30, 2012
Last updated: November 23, 2015
Last verified: November 2015
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

Estimated Enrollment: 480
Study Start Date: March 2013
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 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


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

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 identifier: NCT01741194

Contact: Janet Vogel 303.999-3703
Contact: Sabrina Greer 303.999.3743

  Hide Study Locations
United States, Arizona
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact: Anne Marie Milliken    602-839-6944   
Principal Investigator: Allison Perrin, MD         
HOPE Research Institute Active, not recruiting
Phoenix, Arizona, United States, 85018
United States, Arkansas
Principals Research Group Completed
Hot Springs, Arkansas, United States, 71901
Clinical Trials, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Stacy Rushing    501-227-6179   
Principal Investigator: Victor Biton, MD         
United States, California
CITrials, Inc. Recruiting
Bellflower, California, United States, 90706
Contact: Maria Rowell    562-748-4999   
Principal Investigator: Elizabeth Zarate-Rowell, MD         
Southern Research LLC Recruiting
Beverly Hills, California, United States, 90210
Contact: Amy Shousha    310-858-7448   
Principal Investigator: John Murphy, MD         
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
Contact: Bobby Shih    714-277-4472   
Principal Investigator: Gustavo Alva, MD         
Diligent Clinical Trials Completed
Downey, California, United States, 90241
UCSD Comprehensive Alzheimer's Program Completed
La Jolla, California, United States, 92037
Senior Clinical Trials, Inc. Completed
Laguna Hills, California, United States, 92653
Collaborative Neuroscience Network Recruiting
Long Beach, California, United States, 90806
Contact: Jennifer Chen    866-787-4257   
Principal Investigator: Omid Omidvar, MD         
Renew Behavioral Health Recruiting
Long Beach, California, United States, 90807
Contact: Joanne Gomez    562-637-3143   
Principal Investigator: Laja Ibraheem, MD         
Pacific Research Network Recruiting
San Diego, California, United States, 92103
Contact: Bud Gavdos    619-294-4302   
Principal Investigator: Stephen Thein, PhD         
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92123
Contact: Mariana Atilano    858-278-3647   
Principal Investigator: Ildiko Kovacs, MD         
Research Across America Recruiting
Santa Ana, California, United States, 92705
Contact: Lorrie Bisesi, PhD    714-542-3008   
Principal Investigator: John Duffy, MD         
Neurological Research Institute Completed
Santa Monica, California, United States, 90404
Redwood Research Medical Group Completed
Santa Rosa, California, United States, 95403
United States, Colorado
Alpine Clinical Research Center Completed
Boulder, Colorado, United States, 80304
IMMUNOe Research Centers Recruiting
Centennial, Colorado, United States, 80112
Contact: Leah Getchell    303-773-9000 ext 1244   
Principal Investigator: Cynthea Blake, MD         
The Mile High Research Center Recruiting
Denver, Colorado, United States, 80218
Contact: Beverly Solis    303-839-9900   
Contact: Amy Greaves    303-839-9900   
Principal Investigator: Jack A Klapper, MD         
United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact: Diane Rabideau    203-419-4420   
Principal Investigator: Joseph Soufer, MD         
United States, Florida
Parkinson's Disease and Movement Disorders Center of Boca Raton Recruiting
Boca Raton, Florida, United States, 33486
Contact    561-392-1818 ext 6      
Contact: Ashley Savona    561-392-1818   
Principal Investigator: Stuart Isaacson, MD         
Meridian Research Recruiting
Brooksville, Florida, United States, 34601
Contact: Cindy Renz    352-597-8839   
Principal Investigator: Kelli Maw, MD, MPH         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact: Cynthia Bouchard, MSW    561-374-8461   
Principal Investigator: Mark Brody, MD         
Neuropsychiatric Research Center of Southwest Florida Completed
Fort Meyers, Florida, United States, 33912
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact: William Torres    954-455-5757   
Principal Investigator: Beth Safirstein, MD         
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Contact    561-209-2400      
Principal Investigator: David Watson, MD         
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Contact: Jose Macias    305-514-8503   
Principal Investigator: Marc Agronin, MD         
Compass Research, LLC Recruiting
Orlando, Florida, United States, 32806
Contact: Tim Schubert    407-426-9299   
Principal Investigator: Eva-Marie Heurich, DO         
Suncoast Neuroscience Associates Recruiting
Petersburg, Florida, United States, 33713
Contact: Natasha Wick    727-202-2629   
Principal Investigator: Steven Cohen, MD, PhD         
The Roskamp Institute Recruiting
Sarasota, Florida, United States, 34243
Contact: Yahdinah Alvarez    941-256-8018   
Principal Investigator: Andrew Keegan, MD         
Meridien Research Recruiting
St. Petersburg, Florida, United States, 33709
Contact: Jane Shafer    727-347-8839   
Principal Investigator: Gigi Lefebvre, MD         
Axiom Clinical Research of Florida Completed
Tampa, Florida, United States, 33609
Stedman Clinical Trials Recruiting
Tampa, Florida, United States, 33613
Contact: Ellen Raisbeck    813-971-8311   
Principal Investigator: Mary Stedman, MD         
Premiere Research Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact: Leslie Daniels    561-845-0500   
Principal Investigator: Carl Sadowsky, MD         
United States, Georgia
NeuroTrials Research, Inc Completed
Atlanta, Georgia, United States, 30342
United States, Indiana
IU Health Partners Adult Neurology Clinic Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Scott Herring    317-963-7402   
Principal Investigator: Martin Farlow, MD         
United States, Louisiana
Lake Charles Clinical Trials Recruiting
Lake Charles, Louisiana, United States, 70629
Contact: Mary Long    337-564-6405   
Principal Investigator: Kashinath Yadalam, MD         
United States, Maryland
Pharmasite Research, Inc. Recruiting
Baltimore, Maryland, United States, 21208
Contact: Hema Venkatesh    410-602-1440   
Principal Investigator: Robert Lehman, MD         
United States, Massachusetts
Alzheimers Disease Center, Quincy Medical Center Active, not recruiting
Somerville, Massachusetts, United States, 02169
Springfield Neurology Associates Recruiting
Springfield, Massachusetts, United States, 01104
Contact: Carin Nelson    413-781-5045   
Principal Investigator: Michael Rossen, MD, PhD         
United States, Michigan
Borgess Research Institute Completed
Kalamazoo, Michigan, United States, 49048
United States, Missouri
Saint Louis University Medical School /Department of Neurology & Psychiatry Recruiting
St. Louis, Missouri, United States, 63104
Contact: Christina Morefield    314-977-4820   
Principal Investigator: W. Maurice Redden, MD         
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Active, not recruiting
Las Vegas, Nevada, United States, 89106
United States, New Jersey
Comprehensive Clinical Research Recruiting
Berlin, New Jersey, United States, 08009
Contact: Lisa Wagenseller    856-753-7335 ext 319   
Principal Investigator: David Hassman, DO         
Alzheimer's Research Corporation Recruiting
Manchester, New Jersey, United States, 08759
Contact: Juanita Smith    732-657-6100   
Principal Investigator: Joseph Shua-Haim, MD         
NeuroCognitive Institute Recruiting
Mt. Arlington, New Jersey, United States, 07856
Contact: Alicia Rodriguez    973-610-0100   
Principal Investigator: Gerald Tramontano, PhD         
The Cognitive Research Center of New Jersey Recruiting
Springfield, New Jersey, United States, 07081
Contact: Ashley Clayton    908-850-4622   
Principal Investigator: Michelle Papka, MD         
Memory Enhancement Center of NJ Recruiting
Toms River, New Jersey, United States, 08755
Contact: Lal Ramani    732-341-9500   
Principal Investigator: Sanjiv Sharma, MD         
Neurology Specialists of Monmouth County Recruiting
West Long Branch, New Jersey, United States, 07764
Contact: Jonathan Tutnauer    732-935-1850   
Principal Investigator: Noah Gilson, MD         
United States, New Mexico
Albuquerque Neuroscience, Inc. Recruiting
Albuquerque, New Mexico, United States, 87109
Contact: Jose Munoz    505-848-3773   
Principal Investigator: Glenn Dempsey, MD         
United States, New York
Integrative Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11229
Contact: Lyudmila Grishina    718-444-7774   
Principal Investigator: Inna Yuryev-Golger, MD         
SPRI Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11235
Contact: Svitlana Shylman    718-616-2400   
Principal Investigator: Nick Vatakis, MD         
The Litwin-Zucker Research Center Not yet recruiting
Manhasset, New York, United States, 11030
Contact: Erica Christen, MS,RN    516-562-3492   
Contact: Michelle Gong    516-562-3492   
Principal Investigator: Marc L Gordon, MD         
Parker Jewish Institute For Health Care & Rehabilitation Active, not recruiting
New Hyde Park, New York, United States, 11040
Eastside Comprehensive Medical Center, LLC Recruiting
New York, New York, United States, 10021
Contact: Sonia Pizarro    212-288-0138   
Principal Investigator: Ram Shrivastava, MD         
NYU Langone Medical Center Comprehensive Center on Brain Aging Completed
New York, New York, United States, 10016
Nathan S. Kline Institute Geriatric Psychiatry Program Recruiting
Orangeburg, New York, United States, 10962
Contact: Chelsea Reichert    845-398-5579   
Principal Investigator: Nunzio Pomara, MD         
United States, North Carolina
New Hope Clinical Research Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Andrea McDaniel-Harper    704-817-7732   
Principal Investigator: Eric Semeko, MD         
Ani Neurology, PLLC dba Alzheimer's Memory Ctr Recruiting
Charlotte, North Carolina, United States, 28211
Contact: Kristin Edwards    704-364-4000 ext 225    KEDWARDS@AMCNEUROLOGY.COM   
Principal Investigator: Mohammad Bolouri, MD         
United States, Ohio
Neuro-Behavioral Clinical Research, Inc. Recruiting
Canton, Ohio, United States, 44718
Contact: Lisa Boyce    330-493-1118   
Principal Investigator: Shishuka Malhotra, MD         
Valley Medical Research Recruiting
Centerville, Ohio, United States, 45459
Contact: Cyndi Whittington    937-208-8298   
Principal Investigator: Meenakshi Patel, MD         
CTI Clinical Research Center Active, not recruiting
Cincinnati, Ohio, United States, 45227
Insight Clinical Trials LLC Recruiting
Shaker Heights, Ohio, United States, 44122
Contact: Elisa Poggi    216-832-6606   
Sub-Investigator: Deborah Gould, MD         
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact: Natasha Anderson    405-235-8188   
Principal Investigator: Louise Thurman, MD, MPh         
United States, Oregon
Summit Research Network (Oregon) Inc. Active, not recruiting
Portland, Oregon, United States, 97210
United States, Pennsylvania
Drexel Neurological Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact: Carolyn Edwards    215-762-7090   
Principal Investigator: Carol Lippa, MD         
Abington Neurological Associates Recruiting
Willow Grove, Pennsylvania, United States, 19090
Contact: Daniel Han    215-957-9250   
Principal Investigator: David Weisman, MD         
United States, South Carolina
Medical University of South Carolina Completed
Charleston, South Carolina, United States, 29406
United States, Tennessee
Neurology Clinic, P.C. Completed
Cordova, Tennessee, United States, 38018
Clinical Research Solutions Recruiting
Franklin, Tennessee, United States, 37064
Contact: William Adamson    615-577-4017   
Principal Investigator: Alex Slandzicki, MD         
Clinical Neuroscience Solutions, Inc Recruiting
Memphis, Tennessee, United States, 38119
Contact: Robyn Presley    901-843-1045   
Principal Investigator: Lora McGill, MD         
United States, Texas
Senior Adults Specialty Research, Inc Recruiting
Austin, Texas, United States, 78757
Contact: Heather Bourek    512-407-8628   
Principal Investigator: Jaron Winston, MD         
Texas Neurology Completed
Dallas, Texas, United States, 75214
Baylor College of Medicine Active, not recruiting
Houston, Texas, United States, 77030
United States, Utah
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact: Karen George    801-288-0607   
Principal Investigator: James Wood, MD         
United States, Virginia
National Clinical Research - Richmond, Inc. Completed
Richmond, Virginia, United States, 23294
United States, Washington
Northwest Clinical Research Center Withdrawn
Bellevue, Washington, United States, 98007
VA Puget Sound-Alzhemier's Disease Research Center Active, not recruiting
Seattle, Washington, United States, 98108
Sponsors and Collaborators
Accera, Inc.
Study Director: Samuel T Henderson, PhD Accera, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Accera, Inc. Identifier: NCT01741194     History of Changes
Other Study ID Numbers: AC-12-010
Study First Received: November 30, 2012
Last Updated: November 23, 2015
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
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies processed this record on November 25, 2015