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AC-1204 for Mild to Moderate Alzheimer's Disease

Completed

This study will evaluate the effects of the compound AC-1204 on cognition, activities of daily living, quality of life, pharmacokinetic measures, and safety in people with mild to moderate Alzheimer's disease.

Minimum Age Maximum Age Gender Healthy Volunteers
66 Years 90 Years Both No
March 2013
July 2016
480

  • Probable mild to moderate Alzheimer's dementia, with evidence from CT or MRI scan within the past 18 months and Wechsler Memory Scale-Logical Memory II score (CT or MRI scan may be conducted as part of the screening procedure)
  • Confirmed apolipoprotein E genotype prior to randomization
  • Stable medical condition, with the exception of dementia, for at least 3 consecutive months prior to screening
  • Permanent, English- or Spanish-speaking caregiver (not expected to change during the course of the study) who is willing to attend all visits, oversee the participant's compliance with study procedures, and report the participant's status
  • Community dwelling (includes assisted living facilities but excludes long-term care nursing facilities)
  • Ability to read and write in English or Spanish
  • Hearing, vision, and physical abilities adequate to perform the assessments
  • Ability to ingest oral medication; prior and current use of medication that corresponds with protocol requirements
  • Informed consent by participant or cognitively intact, legally acceptable representative 

  • Cause of dementia other than Alzheimer's disease, as determined by CT or MRI scan within the past 18 months
  • Prohibited medications: 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
  • Presence or history of advanced, severe, progressive or unstable disease of any type that could interfere with the study or put the participant at risk
  • History or clinical laboratory evidence of moderate congestive heart failure; clinically significant ECG abnormalities at screening; history of new cardiovascular events within 6 months before baseline
  • Systolic blood pressure (top number) of more than 165 mmHg; diastolic blood pressure (bottom number) of more than 95 mmHg; or drop of 20 mm Hg or more in systolic blood pressure upon standing upright from a seated position within 3 minutes at screening
  • History of or current psychiatric illness, including: major depression, active suicidal thoughts within 6 months of screening, suicide attempt in the past 2 years; history of alcohol or drug abuse within the past 6 months
  • Insulin-dependent diabetes
  • Clinically significant anemia; clinically significant renal disease or insufficiency; history of severe liver disease or results of liver-function tests more than 2.5 times the upper limit of normal
  • Fasting triglycerides are more than 2.5 times the upper limit of normal
  • Clinically significant vitamin B12 deficiency within the past year
  • History of significant gastrointestinal (GI) disease:
    • Inflammatory bowel disease, GI bleed, or peptic ulcer disease (any history)
    • Complicated reflux disease or severe GERD that is not well-controlled by medication (current history or within past 5 years)
    • Irritable bowel syndrome, diverticular disease, or chronic gastritis (diagnosis or acute event within past 5 years
  • Donation of at least 2 units of blood within the past 2 months
  • 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
  • Expected hospitalization and/or surgery during the course of the study

In this Phase II/III study, participants will be randomized to take either the study drug, AC-1204, or a placebo for 6 months to determine the effects on cognitive status. The drug is a powder that will be mixed with water, other liquid, or soft food. AC-1204 is an experimental compound that targets the metabolic deficiencies and imbalances associated with Alzheimer’s disease by providing ketone bodies as an alternative energy source for brain cells that have defective glucose metabolism. This approach has been shown to safely improve cognitive function and memory in people with Alzheimer's disease and in preclinical animal models of dementia.

There is also an optional extension study in which patients will receive AC-1204 for 6 months. For more information about these trials, visit www.ad-trial.com.

Name City State Zip Status Primary Contact
University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
Birmingham Alabama 35294 n/a

Banner Alzheimer's Institute
Phoenix Arizona 85006 n/a

HOPE Research Institute
Phoenix Arizona 85018 n/a

Principals Research Group
Hot Springs Arkansas 71901 n/a

Clinical Trials, Inc.
Little Rock Arkansas 72205 n/a

CITrials, Inc.
Bellflower California 90706 n/a

Southern Research LLC
Beverly Hills California 90210 n/a

ATP Clinical Research, Inc.
Costa Mesa California 92626 n/a

Diligent Clinical Trials
Downey California 90241 n/a

UCSD Comprehensive Alzheimer's Program
La Jolla California 92037 n/a

Alliance Research Centers
Laguna Hills California 92653 n/a

Senior Clinical Trials, Inc.
Laguna Hills California 92653 n/a

Collaborative Neuroscience Network
Long Beach California 90806 n/a

Alliance for Research
Long Beach California 90807 n/a

Renew Behavioral Health
Long Beach California 90807 n/a

Pacific Research Network
San Diego California 92103 n/a

Artemis Institute for Clinical Research
San Diego California 92123 n/a

Research Across America
Santa Ana California 92705 n/a

Redwood Research Medical Group
Santa Rosa California 95403 n/a

Alpine Clinical Research Center
Boulder Colorado 80304 n/a

IMMUNOe Research Centers
Centennial Colorado 80112 n/a

The Mile High Research Center
Denver Colorado 80218 n/a

Chase Medical Research of Greater New Haven
Hamden Connecticut 06517 n/a

Chase Medical Research, LLC
Waterbury Connecticut 06708 n/a

Parkinson's Disease and Movement Disorders Center of Boca Raton
Boca Raton Florida 33486 n/a

Meridian Research
Brooksville Florida 34601 n/a

Brain Matters Research
Delray Beach Florida 33445 n/a

Neuropsychiatric Research Center of Southwest Florida
Fort Myers Florida 33912 n/a

MD Clinical
Hallandale Beach Florida 33009 n/a

Alzheimer's Research and Treatment Center
Lake Worth Florida 33449 n/a

Miami Jewish Health Systems
Miami Florida 33137 n/a

Compass Research, LLC
Orlando Florida 32806 n/a

Meridien Research
Saint Petersburg Florida 33709 n/a

Suncoast Neuroscience Associates
Saint Petersburg Florida 33713 n/a

The Roskamp Institute
Sarasota Florida 34243 n/a

Axiom Clinical Research of Florida
Tampa Florida 33609 n/a

Stedman Clinical Trials
Tampa Florida 33613 n/a

Premiere Research Institute
West Palm Beach Florida 33407 n/a

NeuroTrials Research, Inc
Atlanta Georgia 30342 n/a

IU Health Partners Adult Neurology Clinic
Indianapolis Indiana 46202 n/a

Lake Charles Clinical Trials
Lake Charles Louisiana 70629 n/a

Pharmasite Research, Inc.
Baltimore Maryland 21208 n/a

Alzheimers Disease Center, Quincy Medical Center
Somerville Massachusetts 02169 n/a

Springfield Neurology Associates
Springfield Massachusetts 01104 n/a

Borgess Research Institute
Kalamazoo Michigan 49048 n/a

Saint Louis University Medical School /Department of Neurology & Psychiatry
Saint Louis Missouri 63104 n/a

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106 n/a

Comprehensive Clinical Research
Berlin New Jersey 08009 n/a

Alzheimer's Research Corporation
Manchester Township New Jersey 08759 n/a

NeuroCognitive Institute
Mount Arlington New Jersey 07856 n/a

The Cognitive Research Center of New Jersey
Springfield New Jersey 07081 n/a

Memory Enhancement Center of NJ
Toms River New Jersey 08755 n/a

Neurology Specialists of Monmouth County
West Long Branch New Jersey 07764 n/a

Albuquerque Neuroscience, Inc.
Albuquerque New Mexico 87109 n/a

Integrative Clinical Trials, LLC
Brooklyn New York 11229 n/a

SPRI Clinical Trials, LLC
Brooklyn New York 11235 n/a

The Litwin-Zucker Research Center
Manhasset New York 11030 n/a

Parker Jewish Institute For Health Care & Rehabilitation
New Hyde Park New York 11040 n/a

NYU Langone Medical Center Comprehensive Center on Brain Aging
New York New York 10016 n/a

Eastside Comprehensive Medical Center, LLC
New York New York 10021 n/a

Nathan S. Kline Institute Geriatric Psychiatry Program
Orangeburg New York 10962 n/a

New Hope Clinical Research
Charlotte North Carolina 28204 n/a

Ani Neurology, PLLC dba Alzheimer's Memory Ctr
Charlotte North Carolina 28211 n/a

Neuro-Behavioral Clinical Research, Inc.
Canton Ohio 44718 n/a

Valley Medical Research
Centerville Ohio 45459 n/a

CTI Clinical Research Center
Cincinnati Ohio 45227 n/a

Insight Clinical Trials LLC
Shaker Heights Ohio 44122 n/a

IPS Research Company
Oklahoma City Oklahoma 73103 n/a

Summit Research Network (Oregon) Inc.
Portland Oregon 97210 n/a

Drexel Neurological Associates
Philadelphia Pennsylvania 19107 n/a

Abington Neurological Associates
Willow Grove Pennsylvania 19090 n/a

Medical University of South Carolina
Charleston South Carolina 29406 n/a

Neurology Clinic, P.C.
Cordova Tennessee 38018 n/a

Clinical Research Solutions
Franklin Tennessee 37064 n/a

Clinical Neuroscience Solutions, Inc
Memphis Tennessee 38119 n/a

Senior Adults Specialty Research, Inc
Austin Texas 78757 n/a

Texas Neurology
Dallas Texas 75214 n/a

Baylor College of Medicine
Houston Texas 77030 n/a

Wasatch Clinical Research
Salt Lake City Utah 84107 n/a

National Clinical Research - Richmond, Inc.
Richmond Virginia 23294 n/a

VA Puget Sound-Alzhemier's Disease Research Center
Seattle Washington 98108 n/a

Accera, Inc.

Name Role Affiliation
Omid Omidvar, MD Principal Investigator Collaborative Neuroscience Network
Stephen Thein, PhD Principal Investigator Pacific Research Network
Susan Steen, MD Principal Investigator Axiom Clinical Research of Florida

Name Phone Email
Janet Vogel 303-999-3703 jvogel@accerapharma.com
Sabrina Greer 303-999.3743 sgreer@accerapharma.com

NCT01741194

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