Alzheimer's Disease Education and Referral Center

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 Age	Max Age	Gender	Healthy 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	City	State	Zip Code	Status	Primary Contact
Geolocation is 33.4962205, -111.9641728	Phoenix	Arizona	85018	Recruiting	Name: Phone:
Geolocation is 34.7486563, -92.3542193	Little Rock	Arkansas	72205	Recruiting	Name: Phone:
Geolocation is 34.0736204, -118.4003563	Beverly Hills	California	90210	Recruiting	Name: Phone:
Geolocation is 33.6834142, -117.9073244	Costa Mesa	California	92626	Recruiting	Name: Phone:
Geolocation is 33.599722, -117.699444	Laguna Hills	California	92653	Recruiting	Name: Phone:
Geolocation is 33.8065036, -118.1912538	Long Beach	California	90806	Recruiting	Name: Phone:
Geolocation is 32.8102534, -117.1323579	San Diego	California	92123	Recruiting	Name: Phone:
Geolocation is 32.749789, -117.1676501	San Diego	California	92103	Recruiting	Name: Phone:
Geolocation is 33.7455731, -117.8678338	Santa Ana	California	92705	Recruiting	Name: Phone:
Geolocation is 34.02875, -118.4717975	Santa Monica	California	90404	Recruiting	Name: Phone:
Geolocation is 38.4739555, -122.7520139	Santa Rosa	California	95403	Recruiting	Name: Phone:
Geolocation is 40.0454736, -105.2838511	Boulder	Colorado	80304	Recruiting	Name: Phone:
Geolocation is 41.5528933, -73.0759446	Waterbury	Connecticut	06708	Recruiting	Name: Phone:
Geolocation is 28.5552719, -82.3878709	Brooksville	Florida	34601	Recruiting	Name: Phone:
Geolocation is 26.4647478, -80.109357	Delray Beach	Florida	33445	Recruiting	Name: Phone:
Geolocation is 26.5273497, -81.8333656	Fort Meyers	Florida	33912	Recruiting	Name: Phone:
Geolocation is 25.9812024, -80.148379	Hallandale Beach	Florida	33009	Recruiting	Name: Phone:
Geolocation is 26.5907805, -80.2432839	Lake Worth	Florida	33449	Recruiting	Name: Phone:
Geolocation is 25.8207159, -80.1819268	Miami	Florida	33137	Recruiting	Name: Phone:
Geolocation is 28.5085825, -81.3564411	Orlando	Florida	32806	Recruiting	Name: Phone:
Geolocation is 27.4081935, -82.5294065	Sarasota	Florida	34243	Recruiting	Name: Phone:
Geolocation is 27.9407591, -82.5104655	Tampa	Florida	33609	Recruiting	Name: Phone:
Geolocation is 26.7619563, -80.1037721	West Palm Beach	Florida	33407	Recruiting	Name: Phone:
Geolocation is 33.8856615, -84.3699767	Atlanta	Georgia	30342	Recruiting	Name: Phone:
Geolocation is 39.7794767, -86.1700894	Indianapolis	Indiana	46202	Recruiting	Name: Phone:
Geolocation is 30.2310081, -93.2190898	Lake Charles	Louisiana	70629	Recruiting	Name: Phone:
Geolocation is 42.3930959, -71.0884036	Somerville	Massachusetts	02145	Recruiting	Name: Phone:
Geolocation is 42.1341459, -72.5707614	Springfield	Massachusetts	01104	Recruiting	Name: Phone:
Geolocation is 42.2917069, -85.5872286	Kalamazoo	Michigan	49048	Recruiting	Name: Phone:
Geolocation is 36.1922841, -115.1592718	Las Vegas	Nevada	89106	Recruiting	Name: Phone:
Geolocation is 39.7912261, -74.9290536	Berlin	New Jersey	08009	Recruiting	Name: Phone:
Geolocation is 39.9549152, -74.3822058	Manchester	New Jersey	08759	Recruiting	Name: Phone:
Geolocation is 40.7146376, -74.3646122	Summit	New Jersey	07901	Recruiting	Name: Phone:
Geolocation is 40.0207099, -74.2061931	Toms River	New Jersey	08755	Recruiting	Name: Phone:
Geolocation is 40.5860069, -73.9418603	Brooklyn	New York	11235	Recruiting	Name: Phone:
Geolocation is 40.7351018, -73.6879082	New Hyde Park	New York	11040	Recruiting	Name: Phone:
Geolocation is 40.7700703, -73.9580246	New York	New York	10021	Recruiting	Name: Phone:
Geolocation is 41.0464858, -73.9495818	Orangeburg	New York	10962	Recruiting	Name: Phone:
Geolocation is 35.1660032, -80.7934798	Charlotte	North Carolina	28211	Recruiting	Name: Phone:
Geolocation is 40.8540649, -81.460856	Canton	Ohio	44718	Recruiting	Name: Phone:
Geolocation is 39.1495912, -84.3909991	Cincinnati	Ohio	45227	Recruiting	Name: Phone:
Geolocation is 35.4900741, -97.5193093	Oklahoma City	Oklahoma	73103	Recruiting	Name: Phone:
Geolocation is 45.5478224, -122.7288206	Portland	Oregon	97210	Recruiting	Name: Phone:
Geolocation is 32.9221152, -80.0367259	Charleston	South Carolina	29406	Recruiting	Name: Phone:
Geolocation is 35.1376546, -89.7661527	Cordova	Tennessee	38018	Recruiting	Name: Phone:
Geolocation is 35.0772572, -89.84582	Memphis	Tennessee	38119	Recruiting	Name: Phone:
Geolocation is 30.3507705, -97.7362384	Austin	Texas	78757	Recruiting	Name: Phone:
Geolocation is 32.824251, -96.7440467	Dallas	Texas	75214	Recruiting	Name: Phone:
Geolocation is 40.6620696, -111.8866683	Salt Lake City	Utah	84107	Recruiting	Name: Phone:
Geolocation is 37.6284406, -77.5447454	Richmond	Virginia	23294	Recruiting	Name: Phone:

Agency
Accera, Inc.

Facility Investigators:

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

Study Contact:

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

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

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AC-1204 for Mild to Moderate Alzheimer's Disease

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AC-1204 for Mild to Moderate Alzheimer's Disease

AC-1204 for Mild to Moderate Alzheimer's Disease