Hoag Hospital in Orange County, California, is initiating a clinical trial for a promising new investigational treatment for Alzheimer’s disease (AD). ACU193 targets amyloid-beta oligomers and is a different approach to treating Alzheimer’s disease than currently approved medications. ACU193 is designed to locate and bind to amyloid-beta oligomers – proteins that build up in the brain. These proteins are thought to be involved in Alzheimer’s disease symptoms and progression.
Hoag is seeking individuals who have memory problems to consider participating in the trial to assist in evaluating this medication as a potential treatment option. Serving the study as Principal Investigator is Gustavo Alva, M.D., DFAPA, a psychiatrist expert in cognition at Hoag.
Hoag’s Pickup Family Neurosciences Institute is initiating a clinical trial for a promising new investigational treatment for Alzheimer’s disease (AD). Hoag offers a range of care and research services supporting a California county with nearly 3.5 million people.
The Investigational Product
ACU193 is a monoclonal antibody (mAb) discovered and developed based on its selectivity for soluble AβOs, which Acumen believes are the most toxic and pathogenic form of Aβ relative to Aβ monomers and amyloid plaques. Soluble AβOs have been observed to be potent neurotoxins that bind to neurons, inhibit synaptic function, and induce neurodegeneration. By selectively targeting toxic soluble AβOs, ACU193 aims to directly address what a growing body of evidence indicates is a primary underlying cause of the neurodegenerative process in AD.
The investigational product targets the amyloid-beta oligomers and is a different approach to treating Alzheimer’s disease than currently approved medications. ACU193 is designed to locate and bind to amyloid-beta oligomers – proteins that build up in the brain. These proteins are thought to be involved in Alzheimer’s disease symptoms and progression.
The Study
The Phase I study will determine the safety and tolerability of a single intravenous (IV) dose and multiple IV doses of ACU193. Hoag is seeking individuals who have memory problems to consider participating in the trial to assist in evaluating this medication for the treatment of Alzheimer’s disease. There is no cost to participate. Acumen Pharmaceuticals Inc., a clinical-stage biopharmaceutical company focused on the development of novel targeted therapeutics for Alzheimer’s disease, is sponsoring the clinical trial.
This study is the first time ACU193 will be given to people. As all drugs and medical procedures carry a risk of side effects, it is possible that participants may experience some discomfort or other reactions from the use of ACU193. The study staff will explain these potential risks before potential participants decide whether to participate in the study. The safety of participants will be closely monitored throughout the study.
PI Point of View
Dr. Alva, M.D., DFAPA, a psychiatrist expert in cognition at Hoag and the principal investigator, went on the record, “ We’re excited to open this trial at Hoag to study ACU193 for the treatment of Alzheimer’s disease,” said Gustavo Alva, of the study. “More than 6 million Americans are living with Alzheimer’s disease. New, safe, and effective treatments are needed more than ever. Participating in clinical trials is one-way members of our community can help make a difference. If you or a loved one is experiencing memory problems, contact us to find out more about the study.”
Interested in Participating?
Key eligibility criteria for the study includes:
- Age 55 to 90 years old
- Have memory problems that might be a sign of mild cognitive impairment (usually mild memory loss) or mild dementia. The underlying cause of these memory problems may or may not be due to Alzheimer’s disease. Tests given within the study will help to determine this.
- Have a caregiver or study partner; someone who knows the participant very well, who is willing to assist with participation in the study and can attend the study visits with the participant. The staff at the study center will explain the complete list of requirements.
Study participants will receive a full diagnostic work-up, including an amyloid PET scan and MRI that can provide a more accurate diagnosis and help guide future treatment options. After finishing this study, participants may consider participating in future studies of ACU193 in which all participants could receive ACU193 at some point in the study.
Call to Action: For more information about the study, please call 949-764-6797 or email clinicalresearch@hoag.org.
By: TrialSite News
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