Alzheimer's Disease Education and Referral Center

AC-1204 for Mild to Moderate Alzheimer's Disease

AC-1204 for Mild to Moderate Alzheimer's Disease

Overall Status: 
Active, not recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
66 Years
90 Years
Both
No
Inclusion Criteria: 
    • 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 
Exclusion Criteria: 
    • 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
Detailed Description: 

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.

Locations: 
Map Marker CityStateZip CodePrimary Contact

Geolocation is 33.5075555, -86.8093239

University of Alabama at Birmingham, Department of Neurology, Memory Disorders Division
Birmingham
Alabama
35294

Geolocation is 33.4636012, -112.0535987

Banner Alzheimer's Institute
Phoenix
Arizona
85006

Geolocation is 33.4962205, -111.9641728

HOPE Research Institute
Phoenix
Arizona
85018

Geolocation is 34.5037004, -93.0551795

Principals Research Group
Hot Springs
Arkansas
71901

Geolocation is 34.7486563, -92.3542193

Clinical Trials, Inc.
Little Rock
Arkansas
72205

Geolocation is 33.8816818, -118.1170117

CITrials, Inc.
Bellflower
California
90706

Geolocation is 34.0736204, -118.4003563

Southern Research LLC
Beverly Hills
California
90210

Geolocation is 33.6834142, -117.9073244

ATP Clinical Research, Inc.
Costa Mesa
California
92626

Geolocation is 33.9372725, -118.1298234

Diligent Clinical Trials
Downey
California
90241

Geolocation is 32.8328112, -117.2712717

UCSD Comprehensive Alzheimer's Program
La Jolla
California
92037

Geolocation is 33.590277, -117.6962824

Alliance Research Centers
Laguna Hills
California
92653

Geolocation is 33.590277, -117.6962824

Senior Clinical Trials, Inc.
Laguna Hills
California
92653

Geolocation is 33.8065036, -118.1912538

Collaborative Neuroscience Network
Long Beach
California
90806

Geolocation is 33.8332465, -118.1766294

Alliance for Research
Long Beach
California
90807

Geolocation is 33.8332465, -118.1766294

Renew Behavioral Health
Long Beach
California
90807

Geolocation is 32.749789, -117.1676501

Pacific Research Network
San Diego
California
92103

Geolocation is 32.8102534, -117.1323579

Artemis Institute for Clinical Research
San Diego
California
92123

Geolocation is 33.7455731, -117.8678338

Research Across America
Santa Ana
California
92705

Geolocation is 34.02875, -118.4717975

Neurological Research Institute
Santa Monica
California
90404

Geolocation is 38.4739555, -122.7520139

Redwood Research Medical Group
Santa Rosa
California
95403

Geolocation is 40.0454736, -105.2838511

Alpine Clinical Research Center
Boulder
Colorado
80304

Geolocation is 39.5835785, -104.8571368

IMMUNOe Research Centers
Centennial
Colorado
80112

Geolocation is 39.732746, -104.9710123

The Mile High Research Center
Denver
Colorado
80218

Geolocation is 41.3469288, -72.9047136

Chase Medical Research of Greater New Haven
Hamden
Connecticut
06517

Geolocation is 41.5528933, -73.0759446

Chase Medical Research, LLC
Waterbury
Connecticut
06708

Geolocation is 26.3424842, -80.1149414

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

Geolocation is 28.5552719, -82.3878709

Meridian Research
Brooksville
Florida
34601

Geolocation is 26.4647478, -80.109357

Brain Matters Research
Delray Beach
Florida
33445

Geolocation is 26.5273497, -81.8333656

Neuropsychiatric Research Center of Southwest Florida
Fort Meyers
Florida
33912

Geolocation is 25.9812024, -80.148379

MD Clinical
Hallandale Beach
Florida
33009

Geolocation is 26.5907805, -80.2432839

Alzheimer's Research and Treatment Center
Lake Worth
Florida
33449

Geolocation is 25.8207159, -80.1819268

Miami Jewish Health Systems
Miami
Florida
33137

Geolocation is 28.5085825, -81.3564411

Compass Research, LLC
Orlando
Florida
32806

Geolocation is 27.7896783, -82.6807458

Suncoast Neuroscience Associates
Petersburg
Florida
33713

Geolocation is 27.4081935, -82.5294065

The Roskamp Institute
Sarasota
Florida
34243

Geolocation is 27.8219579, -82.7401087

Meridien Research
St. Petersburg
Florida
33709

Geolocation is 27.9407591, -82.5104655

Axiom Clinical Research of Florida
Tampa
Florida
33609

Geolocation is 28.0869646, -82.4698603

Stedman Clinical Trials
Tampa
Florida
33613

Geolocation is 26.7619563, -80.1037721

Premiere Research Institute
West Palm Beach
Florida
33407

Geolocation is 33.8856615, -84.3699767

NeuroTrials Research, Inc
Atlanta
Georgia
30342

Geolocation is 39.7794767, -86.1700894

IU Health Partners Adult Neurology Clinic
Indianapolis
Indiana
46202

Geolocation is 30.2310081, -93.2190898

Lake Charles Clinical Trials
Lake Charles
Louisiana
70629

Geolocation is 39.3744588, -76.745195

Pharmasite Research, Inc.
Baltimore
Maryland
21208

Geolocation is 42.4293456, -71.1084766

Alzheimers Disease Center, Quincy Medical Center
Somerville
Massachusetts
02169

Geolocation is 42.1341459, -72.5707614

Springfield Neurology Associates
Springfield
Massachusetts
01104

Geolocation is 42.3238865, -85.5869352

Borgess Research Institute
Kalamazoo
Michigan
49048

Geolocation is 38.6160491, -90.2291565

Saint Louis University Medical School /Department of Neurology & Psychiatry
St. Louis
Missouri
63104

Geolocation is 36.1922841, -115.1592718

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

Geolocation is 39.7912261, -74.9290536

Comprehensive Clinical Research
Berlin
New Jersey
08009

Geolocation is 39.9549152, -74.3822058

Alzheimer's Research Corporation
Manchester
New Jersey
08759

Geolocation is 40.9259319, -74.6348828

NeuroCognitive Institute
Mt. Arlington
New Jersey
07856

Geolocation is 40.7016937, -74.3222146

The Cognitive Research Center of New Jersey
Springfield
New Jersey
07081

Geolocation is 40.0207099, -74.2061931

Memory Enhancement Center of NJ
Toms River
New Jersey
08755

Geolocation is 40.2903891, -74.0176381

Neurology Specialists of Monmouth County
West Long Branch
New Jersey
07764

Geolocation is 35.1590068, -106.5760857

Albuquerque Neuroscience, Inc.
Albuquerque
New Mexico
87109

Geolocation is 40.5988077, -73.9447994

Integrative Clinical Trials, LLC
Brooklyn
New York
11229

Geolocation is 40.5860069, -73.9418603

SPRI Clinical Trials, LLC
Brooklyn
New York
11235

Geolocation is 40.7978787, -73.6995749

The Litwin-Zucker Research Center
Manhasset
New York
11030

Geolocation is 40.7351018, -73.6879082

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

Geolocation is 40.74727, -73.9800645

NYU Langone Medical Center Comprehensive Center on Brain Aging
New York
New York
10016

Geolocation is 40.7700703, -73.9580246

Eastside Comprehensive Medical Center, LLC
New York
New York
10021

Geolocation is 41.0464858, -73.9495818

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

Geolocation is 35.2150714, -80.8294747

New Hope Clinical Research
Charlotte
North Carolina
28204

Geolocation is 35.1660032, -80.7934798

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

Geolocation is 40.8540649, -81.460856

Neuro-Behavioral Clinical Research, Inc.
Canton
Ohio
44718

Geolocation is 39.6400784, -84.1751648

Valley Medical Research
Centerville
Ohio
45459

Geolocation is 39.1495912, -84.3909991

CTI Clinical Research Center
Cincinnati
Ohio
45227

Geolocation is 41.4739419, -81.5370671

Insight Clinical Trials LLC
Shaker Heights
Ohio
44122

Geolocation is 35.4900741, -97.5193093

IPS Research Company
Oklahoma City
Oklahoma
73103

Geolocation is 45.5478224, -122.7288206

Summit Research Network (Oregon) Inc.
Portland
Oregon
97210

Geolocation is 39.9559288, -75.1574567

Drexel Neurological Associates
Philadelphia
Pennsylvania
19107

Geolocation is 40.1439985, -75.1157286

Abington Neurological Associates
Willow Grove
Pennsylvania
19090

Geolocation is 32.9221152, -80.0367259

Medical University of South Carolina
Charleston
South Carolina
29406

Geolocation is 35.1376546, -89.7661527

Neurology Clinic, P.C.
Cordova
Tennessee
38018

Geolocation is 35.9250637, -86.8688899

Clinical Research Solutions
Franklin
Tennessee
37064

Geolocation is 35.0772572, -89.84582

Clinical Neuroscience Solutions, Inc
Memphis
Tennessee
38119

Geolocation is 30.3568213, -97.730807

Senior Adults Specialty Research, Inc
Austin
Texas
78757

Geolocation is 32.824251, -96.7440467

Texas Neurology
Dallas
Texas
75214

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030

Geolocation is 40.6620696, -111.8866683

Wasatch Clinical Research
Salt Lake City
Utah
84107

Geolocation is 37.6284406, -77.5447454

National Clinical Research - Richmond, Inc.
Richmond
Virginia
23294

Geolocation is 47.5405059, -122.3045438

VA Puget Sound-Alzhemier's Disease Research Center
Seattle
Washington
98108
Lead Sponsor: 
Agency
Accera, Inc.
Collaborator Sponsor: 
Facility Investigators: 
NameRoleAffiliation
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
Study Contact: 
NamePhoneEmail
Janet Vogel
303-999-3703
Sabrina Greer
303-999.3743
Locations
 
 
ClinicalTrials.gov ID 
NCT01741194 (follow link to view full record on ct.gov in new window)
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
Study Start Date: 
March 2013
Study End Date: 
July 2016
Disease Stage: 
Early
Middle
Enrollment: 
480