It is hoped that the study drug being investigated will help people with mild to moderate Alzheimer's disease. The research will test if the study drug improves memory, other mental skills, and overall quality of life in people with Alzheimer’s disease.
About this trial
The study drug (AC-1204) is administered by Liquid or Syrup.
This is a phase 3 trial. What does this mean? A phase 3 trial means that the study drug has been taken by other participants under the supervision of medical professionals.
people have already taken this drug in clinical trials
There will be480
participants in this trial, at 41 sites around the world
- be between 66 – 90 years old
- be experiencing moderate to severe memory loss, dementia or Alzheimer's disease
- have a caregiver who is able to attend all study visits
Participants must not:
- be allergic to milk or soy products
- have major psychiatric illness such as schizophrenia or bipolar affective disorder
This trial is 26 weeks long, requiring 5 visits and 0 overnight stays.
A placebo is being used for this trial.
The sponsor of this trial is Accera, Inc..
The results of this trial will be published.
Patients will not be able to continue taking the medication after the trial.
All study related medications, analysis, hospital visits, and procedures are free.
Reasonable travel expenses will be reimbursed.
Also, if you complete the trial you will receive a variable amount for your time and inconvenience.
This study will take place in 1 country
41 sites will be participating.
- Centennial, IMMUNOe Research Centers , 80112
- Denver, Mile High Research Center , 80218
- West Palm Beach, Premiere Research Institute, 33407
- St. Petersburg, Suncoast Neuroscience Associates, 33713
- Hallandale Beach, MD Clinical , 33009
- Delray Beach, Brain Matters Research, 33445
- Lake Worth, Alzheimer's Research and Treatment Center, 33449
- Sarasota, The Roskamp Institute, 34243
- Brooksville, Meridian Research, 34601
- Tampa, Stedman Clinical Trials, 33613
- Miami, Miami Jewish Health Systems, 33137
- Albuquerque , Albuquerque Neuroscience, Inc., 87109
- West Long Branch, Neurology Specialists of Monmouth County, 07764
- Mt. Arlington, NeuroCognitive Institute, 07856
- Berlin, Comprehensive Clinical Research, 08009
- Springfield, The Cognitive Research Center of New Jersey, 07081
- Manchester, Alzheimer’s Research Corporation, 08759
- Charlotte, New Hope Clinical Research, 28204
- Brooklyn, Integrative Clinical Trials, LLC, 11229
- Brooklyn, SPRI Clinical Trials, LLC, 11235
- New York, Eastside Comprehensive Medical Center, LLC, 10021
- Orangeburg, Nathan S. Kline InstituteGeriatric Psychiatry Program, 10962
- Franklin, Clinical Research Solutions, 37064
- Springfield, Springfield Neurology Associates, 01104
- Salt Lake City, Wasatch Clinical Research LLC, 84107
- Baltimore, Pharmasite Research, Inc., 21208
- Oklahoma City, IPS Research Company, 73103
- Austin, Senior Adults Specialty Research, Inc, 78757
- Lake Charles, Lake Charles Clinical Trials, 70629
- Abington, Abington Neurological Associates, 19001
- Philadelphia, Drexel Neurological Associates, 19107
- Boca Raton, Parkinson’s Disease and Movement Disorders Center of Boca Raton, 33486
- Little Rock, Clinical Trials, Inc. , 72205
- Centerville, Valley Medical Research, 45459
- St. Petersburg, Meridien Research, 33709
- Bellflower, CITrials, Inc., 90706
- Long Beach, Renew Behavioral Health, 90807
- Costa Mesa, ATP Clinical Research, Inc., 92626
- Long Beach, Collaborative Neuroscience Network, 90806
- Santa Ana, Research Across America, 92705
- Simi Valley, Southern California Research LLC, 93065
You are being asked to take part in this research study to test the safety and effectiveness of an investigational drug called AC-1204 for people with mild to moderate Alzheimer’s disease. Research studies have shown that the brains of people with Alzheimer’s disease often have difficulty using glucose. Glucose, a simple form of sugar, is the brain's primary source of energy. Your body also makes ketone bodies, another energy source that your brain can use in place of glucose. The purpose of this study is to see whether increasing ketone body levels with AC-1204, will improve test scores that measure memory and other mental skills in subjects with Alzheimer’s disease. An optional 26-week extension with 3 visits is available. During this extension, all participants will receive AC-1204.
Frequently asked questions
What are clinical trials?
Clinical trials are research studies to determine whether investigational drugs or treatments are safe and effective for humans. All new investigational medications and devices must undergo several clinical trials, often involving thousands of people.
Can I quit a trial?
You can quit a clinical trial at any time and you do not have to give a reason. There is no charge or penalty for quitting.
Why participate in a clinical trial?
You will have access to new investigational treatments that would be available to the general public only upon approval. You will also receive study-related medical care and attention from clinical trial staff at research facilities. Clinical trials offer hope for many people and an opportunity to help researchers find better treatments for others in the future.
What are the benefits and risks of clinical trials?
You may or may not receive direct clinical benefit from this study but your participation will provide important information to help researchers learn more about the condition and possibly develop better treatments for future patients.
Is my information safe?
The Study Information is used only for research purposes and will be kept confidential within the limits of the law of your country. If the results of this study are published or presented in a meeting, you will not be named and nobody will be able to tell that you were in the study from the publication or presentation.
Any other questions?
If you would like to speak to someone regarding this trial fill in this quick questionnaire. If you are eligible someone from the research team will contact you by phone and explain everything in more detail.
You are under no obligation to proceed even if you fill it in and can drop out at any point.