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 May 2014 by Accera, Inc.
Sponsor:
Information provided by (Responsible Party):
Accera, Inc.
ClinicalTrials.gov Identifier:
NCT01741194
First received: November 30, 2012
Last updated: July 11, 2014
Last verified: May 2014
  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


Estimated Enrollment: 480
Study Start Date: March 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (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

Contacts
Contact: Janet Vogel 303.999-3703 jvogel@accerapharma.com
Contact: Sabrina Greer 303.999.3743 sgreer@accerapharma.com

  Hide Study Locations
Locations
United States, Arizona
HOPE Research Institute Recruiting
Phoenix, Arizona, United States, 85018
Contact    602-288-4673      
Principal Investigator: Jeffrey Gitt, DO         
Banner Alzheimer's Institute Recruiting
Phoenix, Arizona, United States, 85006
Contact    602-839-6967      
Principal Investigator: Allison Perrin, MD         
United States, Arkansas
Principals Research Group Recruiting
Hot Springs, Arkansas, United States, 71901
Contact    501-321-0547      
Principal Investigator: Gordon Gibson, MD         
Clinical Trials, Inc. Recruiting
Little Rock, Arkansas, United States, 72205
Contact    501-227-6179      
Principal Investigator: Victor Biton, MD         
United States, California
Southern Research LLC Recruiting
Beverly Hills, California, United States, 90210
Contact    310-858-7448      
Principal Investigator: John Murphy, MD         
ATP Clinical Research, Inc. Recruiting
Costa Mesa, California, United States, 92626
Contact    714-277-4472      
Principal Investigator: Gustavo Alva, MD         
Diligent Clinical Trials Recruiting
Downey, California, United States, 90241
Contact    562-622-0700      
Principal Investigator: Elizabeth Zarate-Rowell, MD         
UCSD Comprehensive Alzheimer's Program Recruiting
La Jolla, California, United States, 92037
Contact    858-246-1378      
Principal Investigator: Michael Rafii, MD, PhD         
Senior Clinical Trials, Inc. Recruiting
Laguna Hills, California, United States, 92653
Contact    949-588-0909      
Principal Investigator: Robert Feldman, MD         
Collaborative Neuroscience Network Recruiting
Long Beach, California, United States, 90806
Contact    866-787-4257      
Principal Investigator: Omid Omidvar, MD         
Artemis Institute for Clinical Research Recruiting
San Diego, California, United States, 92123
Contact    858-278-3647      
Principal Investigator: Ildiko Kovacs, MD         
Pacific Research Network Recruiting
San Diego, California, United States, 92103
Contact    619-294-4302      
Principal Investigator: Stephen Thein, PhD         
Research Across America Recruiting
Santa Ana, California, United States, 92705
Contact    714-542-3008      
Principal Investigator: John Duffy, MD         
Neurological Research Institute Active, not recruiting
Santa Monica, California, United States, 90404
Redwood Research Medical Group Recruiting
Santa Rosa, California, United States, 95403
Contact    707-521-3814      
Principal Investigator: Allan Bernstein, MD         
United States, Colorado
Alpine Clinical Research Center Recruiting
Boulder, Colorado, United States, 80304
Contact    303-443-7229      
Principal Investigator: Paul Brownstone, MD         
United States, Connecticut
Chase Medical Research, LLC Recruiting
Waterbury, Connecticut, United States, 06708
Contact    203-419-4420      
Principal Investigator: Joseph Soufer, MD         
United States, Florida
Meridian Research Recruiting
Brooksville, Florida, United States, 34601
Contact    352-597-8839      
Principal Investigator: Kelli Maw, MD, MPH         
Brain Matters Research Recruiting
Delray Beach, Florida, United States, 33445
Contact    561-374-8461      
Principal Investigator: Mark Brody, MD         
Neuropsychiatric Research Center of Southwest Florida Active, not recruiting
Fort Meyers, Florida, United States, 33912
MD Clinical Recruiting
Hallandale Beach, Florida, United States, 33009
Contact    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    305-514-8503      
Principal Investigator: Marc Agronin, MD         
Compass Research, LLC Recruiting
Orlando, Florida, United States, 32806
Contact    407-426-9299      
Principal Investigator: Eva-Marie Heurich, DO         
The Roskamp Institute Recruiting
Sarasota, Florida, United States, 34243
Contact    941-256-8018      
Principal Investigator: Andrew Keegan, MD         
Axiom Clinical Research of Florida Recruiting
Tampa, Florida, United States, 33609
Contact    813-353-9613      
Principal Investigator: Susan Steen, MD         
Stedman Clinical Trials Recruiting
Tampa, Florida, United States, 33613
Contact    813-971-8311      
Principal Investigator: Mary Stedman, MD         
Premiere Research Institute Recruiting
West Palm Beach, Florida, United States, 33407
Contact    561-845-0500      
Principal Investigator: Carl Sadowsky, MD         
United States, Georgia
NeuroTrials Research, Inc Recruiting
Atlanta, Georgia, United States, 30342
Contact    404-851-9934      
Principal Investigator: Matthews Gwynn, MD         
United States, Indiana
IU Health Partners Adult Neurology Clinic Recruiting
Indianapolis, Indiana, United States, 46202
Contact    317-963-7402      
Principal Investigator: Martin Farlow, MD         
United States, Louisiana
Lake Charles Clinical Trials Recruiting
Lake Charles, Louisiana, United States, 70629
Contact    337-564-6405      
Principal Investigator: Kashinath Yadalam, MD         
United States, Maryland
Pharmasite Research, Inc. Recruiting
Baltimore, Maryland, United States, 21208
Contact    410-602-1440      
Principal Investigator: Robert Lehman, MD         
United States, Massachusetts
Alzheimers Disease Center, Quincy Medical Center Recruiting
Somerville, Massachusetts, United States, 02145
Contact    617-639-5006      
Principal Investigator: Anil Nair, MD         
Springfield Neurology Associates Recruiting
Springfield, Massachusetts, United States, 01104
Contact    413-781-5045      
Principal Investigator: Michael Rossen, MD, PhD         
United States, Michigan
Borgess Research Institute Recruiting
Kalamazoo, Michigan, United States, 49048
Contact    269-226-4803      
Principal Investigator: Phillip Green, MD         
United States, Missouri
Saint Louis University Medical School /Department of Neurology & Psychiatry Recruiting
St. Louis, Missouri, United States, 63104
Contact    341-977-4811      
Principal Investigator: George Grossberg, MD         
United States, Nevada
Cleveland Clinic Lou Ruvo Center for Brain Health Recruiting
Las Vegas, Nevada, United States, 89106
Contact    702-483-6030      
Principal Investigator: Charles Bernick, MD         
United States, New Jersey
Comprehensive Clinical Research Recruiting
Berlin, New Jersey, United States, 08009
Contact    856-753-7335 ext 319      
Principal Investigator: David Hassman, DO         
Alzheimer's Research Corporation Recruiting
Manchester, New Jersey, United States, 08759
Contact    732-657-6100      
Principal Investigator: Joseph Shua-Haim, MD         
The Cognitive Research Center of New Jersey Recruiting
Summit, New Jersey, United States, 07901
Contact    908-522-5713      
Principal Investigator: Michelle Papka, MD         
Memory Enhancement Center of NJ Recruiting
Toms River, New Jersey, United States, 08755
Contact    732-341-9500      
Principal Investigator: Sanjiv Sharma, MD         
United States, New York
SPRI Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11235
Contact    718-616-2400      
Principal Investigator: Nick Vatakis, MD         
Integrative Clinical Trials, LLC Recruiting
Brooklyn, New York, United States, 11229
Contact    718-444-7774      
Principal Investigator: Inna Yuryev-Golger, MD         
Parker Jewish Institute For Health Care & Rehabilitation Recruiting
New Hyde Park, New York, United States, 11040
Contact    718-289-2103      
Principal Investigator: Cornelius Foley, MD         
Eastside Comprehensive Medical Center, LLC Recruiting
New York, New York, United States, 10021
Contact    212-288-0138      
Principal Investigator: Ram Shrivastava, MD         
NYU Langone Medical Center Comprehensive Center on Brain Aging Recruiting
New York, New York, United States, 10016
Contact    212-263-0770      
Principal Investigator: James Galvin, MD, MPH         
Nathan S. Kline Institute Geriatric Psychiatry Program Recruiting
Orangeburg, New York, United States, 10962
Contact    845-398-5579      
Principal Investigator: Nunzio Pomara, MD         
United States, North Carolina
Ani Neurology, PLLC dba Alzheimer's Memory Ctr Recruiting
Charlotte, North Carolina, United States, 28211
Contact    704-364-4000 ext 225      
Principal Investigator: Mohammad Bolouri, MD         
United States, Ohio
Neuro-Behavioral Clinical Research, Inc. Recruiting
Canton, Ohio, United States, 44718
Contact    330-493-1118      
Principal Investigator: Shishuka Malhotra, MD         
Valley Medical Research Recruiting
Centerville, Ohio, United States, 45459
Contact    937-208-8282      
Principal Investigator: Meenakshi Patel, MD         
Community Research Recruiting
Cincinnati, Ohio, United States, 45227
Contact    513-272-9739      
Principal Investigator: Alfredo Rivera, MD         
United States, Oklahoma
IPS Research Company Recruiting
Oklahoma City, Oklahoma, United States, 73103
Contact    405-235-8188      
Principal Investigator: Louise Thurman, MD, MPh         
United States, Oregon
Summit Research Network (Oregon) Inc. Recruiting
Portland, Oregon, United States, 97210
Contact    503-279-8252      
Principal Investigator: Scott Losk, PhD         
United States, Pennsylvania
Abington Neurological Associates Recruiting
Abington, Pennsylvania, United States, 19001
Contact    215-957-9250      
Principal Investigator: David Weisman, MD         
Drexel Neurological Associates Recruiting
Philadelphia, Pennsylvania, United States, 19107
Contact    215-762-7090      
Principal Investigator: Carol Lippa, MD         
United States, South Carolina
Medical University of South Carolina Active, not recruiting
Charleston, South Carolina, United States, 29406
United States, Tennessee
Neurology Clinic, P.C. Recruiting
Cordova, Tennessee, United States, 38018
Contact    901-866-9252      
Principal Investigator: Thomas Arnold, MD         
Clinical Research Solutions Recruiting
Franklin, Tennessee, United States, 37064
Contact    615-577-4017      
Principal Investigator: Alex Slandzicki, MD         
Clinical Neuroscience Solutions, Inc Recruiting
Memphis, Tennessee, United States, 38119
Contact    901-843-1045      
Principal Investigator: Lora McGill, MD         
United States, Texas
Senior Adults Specialty Research, Inc Recruiting
Austin, Texas, United States, 78757
Contact    512-407-8628      
Principal Investigator: Jaron Winston, MD         
Texas Neurology Active, not recruiting
Dallas, Texas, United States, 75214
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact    713-798-4734 ext opt 2      
Principal Investigator: Rachelle Doody, MD, PhD         
United States, Utah
Wasatch Clinical Research Recruiting
Salt Lake City, Utah, United States, 84107
Contact    702-483-6030      
Principal Investigator: James Wood, MD         
United States, Virginia
National Clinical Research - Richmond, Inc. Active, not recruiting
Richmond, Virginia, United States, 23294
United States, Washington
VA Puget Sound-Alzhemier's Disease Research Center Recruiting
Seattle, Washington, United States, 98108
Contact    206-277-3965      
Principal Investigator: Elaine Peskind, MD         
Sponsors and Collaborators
Accera, Inc.
Investigators
Study Director: Samuel T Henderson, PhD Accera, Inc.
  More Information

Additional Information:
No publications provided

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: July 11, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014