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: 
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
    • 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 9 months 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 inflammatory bowel disease, irritable bowel syndrome, diverticular disease, chronic gastritis, gastrointestinal bleeding, or severe gastroesophageal reflex disease requiring ongoing prescription medication
    • 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.

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4962205, -111.9641728

Site
Phoenix
Arizona
85018
Recruiting
Name:
Phone: 602-288-4673

Geolocation is 33.4636012, -112.0535987

Site
Phoenix
Arizona
85006
Recruiting
Name:
Phone: 602-839-6967

Geolocation is 34.5037004, -93.0551795

Site
Hot Springs
Arkansas
71901
Recruiting
Name:
Phone: 501-321-0547

Geolocation is 34.7486563, -92.3542193

Site
Little Rock
Arkansas
72205
Recruiting
Name:
Phone: 501-227-6179

Geolocation is 34.0736204, -118.4003563

Site
Beverly Hills
California
90210
Recruiting
Name:
Phone: 310-858-7448

Geolocation is 33.6834142, -117.9073244

Site
Costa Mesa
California
92626
Recruiting
Name:
Phone: 714-277-4472

Geolocation is 33.9372725, -118.1298234

Site
Downey
California
90241
Recruiting
Name:
Phone: 562-622-0700

Geolocation is 32.8328112, -117.2712717

Site
La Jolla
California
92037
Recruiting
Name:
Phone: 858-246-1378

Geolocation is 33.599722, -117.699444

Site
Laguna Hills
California
92653
Recruiting
Name:
Phone: 949-588-0909

Geolocation is 33.8065036, -118.1912538

Site
Long Beach
California
90806
Recruiting
Name:
Phone: 866-787-4257

Geolocation is 32.8102534, -117.1323579

Site
San Diego
California
92123
Recruiting
Name:
Phone: 858-278-3647

Geolocation is 32.749789, -117.1676501

Site
San Diego
California
92103
Recruiting
Name:
Phone: 619-294-4302

Geolocation is 33.7455731, -117.8678338

Site
Santa Ana
California
92705
Recruiting
Name:
Phone: 714-542-3008

Geolocation is 34.02875, -118.4717975

Site
Santa Monica
California
90404
Active, not recruiting
Name:
Phone:

Geolocation is 38.4739555, -122.7520139

Site
Santa Rosa
California
95403
Recruiting
Name:
Phone: 707-521-3814

Geolocation is 40.0454736, -105.2838511

Site
Boulder
Colorado
80304
Recruiting
Name:
Phone: 303-443-7229

Geolocation is 41.5528933, -73.0759446

Site
Waterbury
Connecticut
06708
Recruiting
Name:
Phone: 203-419-4420

Geolocation is 28.5552719, -82.3878709

Site
Brooksville
Florida
34601
Recruiting
Name:
Phone: 352-597-8839

Geolocation is 26.4647478, -80.109357

Site
Delray Beach
Florida
33445
Recruiting
Name:
Phone: 561-374-8461

Geolocation is 26.5273497, -81.8333656

Site
Fort Meyers
Florida
33912
Active, not recruiting
Name:
Phone:

Geolocation is 25.9812024, -80.148379

Site
Hallandale Beach
Florida
33009
Recruiting
Name:
Phone: 954-455-5757

Geolocation is 26.5907805, -80.2432839

Site
Lake Worth
Florida
33449
Recruiting
Name:
Phone: 561-209-2400

Geolocation is 25.8207159, -80.1819268

Site
Miami
Florida
33137
Recruiting
Name:
Phone: 305-514-8503

Geolocation is 28.5085825, -81.3564411

Site
Orlando
Florida
32806
Recruiting
Name:
Phone: 407-426-9299

Geolocation is 27.4081935, -82.5294065

Site
Sarasota
Florida
34243
Recruiting
Name:
Phone: 941-256-8018

Geolocation is 27.9407591, -82.5104655

Site
Tampa
Florida
33609
Recruiting
Name:
Phone: 813-353-9613

Geolocation is 28.0869646, -82.4698603

Site
Tampa
Florida
33613
Recruiting
Name:
Phone: 813-971-8311

Geolocation is 26.7619563, -80.1037721

Site
West Palm Beach
Florida
33407
Recruiting
Name:
Phone: 561-845-0500

Geolocation is 33.8856615, -84.3699767

Site
Atlanta
Georgia
30342
Recruiting
Name:
Phone: 404-851-9934

Geolocation is 39.7794767, -86.1700894

Site
Indianapolis
Indiana
46202
Recruiting
Name:
Phone: 317-963-7402

Geolocation is 30.2310081, -93.2190898

Site
Lake Charles
Louisiana
70629
Recruiting
Name:
Phone: 337-564-6405

Geolocation is 39.3744588, -76.745195

Site
Baltimore
Maryland
21208
Recruiting
Name:
Phone: 410-602-1440

Geolocation is 42.3930959, -71.0884036

Site
Somerville
Massachusetts
02145
Recruiting
Name:
Phone: 617-639-5006

Geolocation is 42.1341459, -72.5707614

Site
Springfield
Massachusetts
01104
Recruiting
Name:
Phone: 413-781-5045

Geolocation is 42.2917069, -85.5872286

Site
Kalamazoo
Michigan
49048
Recruiting
Name:
Phone: 269-226-4803

Geolocation is 38.6160491, -90.2291565

Site
St. Louis
Missouri
63104
Recruiting
Name:
Phone: 341-977-4811

Geolocation is 36.1922841, -115.1592718

Site
Las Vegas
Nevada
89106
Recruiting
Name:
Phone: 702-483-6030

Geolocation is 39.7912261, -74.9290536

Site
Berlin
New Jersey
08009
Recruiting
Name:
Phone: 856-753-7335

Geolocation is 39.9549152, -74.3822058

Site
Manchester
New Jersey
08759
Recruiting
Name:
Phone: 732-657-6100

Geolocation is 40.7146376, -74.3646122

Site
Summit
New Jersey
07901
Recruiting
Name:
Phone: 908-522-5713

Geolocation is 40.0207099, -74.2061931

Site
Toms River
New Jersey
08755
Recruiting
Name:
Phone: 732-341-9500

Geolocation is 40.5860069, -73.9418603

Site
Brooklyn
New York
11235
Recruiting
Name:
Phone: 718-616-2400

Geolocation is 40.5988077, -73.9447994

Site
Brooklyn
New York
11229
Recruiting
Name:
Phone: 718-444-7774

Geolocation is 40.7351018, -73.6879082

Site
New Hyde Park
New York
11040
Recruiting
Name:
Phone: 718-289-2103

Geolocation is 40.7700703, -73.9580246

Site
New York
New York
10021
Recruiting
Name:
Phone: 212-288-0138

Geolocation is 40.74727, -73.9800645

Site
New York
New York
10016
Recruiting
Name:
Phone: 212-263-0770

Geolocation is 41.0464858, -73.9495818

Site
Orangeburg
New York
10962
Recruiting
Name:
Phone: 845-398-5579

Geolocation is 35.1660032, -80.7934798

Site
Charlotte
North Carolina
28211
Recruiting
Name:
Phone: 704-364-4000

Geolocation is 40.8540649, -81.460856

Site
Canton
Ohio
44718
Recruiting
Name:
Phone: 330-493-1118

Geolocation is 39.6400784, -84.1751648

Site
Centerville
Ohio
45459
Recruiting
Name:
Phone: 937-208-8282

Geolocation is 39.1495912, -84.3909991

Site
Cincinnati
Ohio
45227
Recruiting
Name:
Phone: 513-272-9739

Geolocation is 35.4900741, -97.5193093

Site
Oklahoma City
Oklahoma
73103
Recruiting
Name:
Phone: 405-235-8188

Geolocation is 45.5478224, -122.7288206

Site
Portland
Oregon
97210
Recruiting
Name:
Phone: 503-279-8252

Geolocation is 40.1313817, -75.1370254

Site
Abington
Pennsylvania
19001
Recruiting
Name:
Phone: 215-957-9250

Geolocation is 39.9559288, -75.1574567

Site
Philadelphia
Pennsylvania
19107
Recruiting
Name:
Phone: 215-762-7090

Geolocation is 32.9221152, -80.0367259

Site
Charleston
South Carolina
29406
Active, not recruiting
Name:
Phone:

Geolocation is 35.1376546, -89.7661527

Site
Cordova
Tennessee
38018
Recruiting
Name:
Phone: 901-866-9252

Geolocation is 35.9250637, -86.8688899

Site
Franklin
Tennessee
37064
Recruiting
Name:
Phone: 615-577-4017

Geolocation is 35.0772572, -89.84582

Site
Memphis
Tennessee
38119
Recruiting
Name:
Phone: 901-843-1045

Geolocation is 30.3568213, -97.730807

Site
Austin
Texas
78757
Recruiting
Name:
Phone: 512-407-8628

Geolocation is 32.824251, -96.7440467

Site
Dallas
Texas
75214
Active, not recruiting
Name:
Phone:

Geolocation is 29.7050857, -95.4018087

Site
Houston
Texas
77030
Recruiting
Name:
Phone: 713-798-4734

Geolocation is 40.6620696, -111.8866683

Site
Salt Lake City
Utah
84107
Recruiting
Name:
Phone: 702-483-6030

Geolocation is 37.6284406, -77.5447454

Site
Richmond
Virginia
23294
Active, not recruiting
Name:
Phone:

Geolocation is 47.5405059, -122.3045438

Site
Seattle
Washington
98108
Recruiting
Name:
Phone: 206-277-3965
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: 
January 2015
Disease Stage: 
Early
Middle
Enrollment: 
480