INTERCEPT-AD Trial
A Phase 1 clinical trial for individuals with early Alzheimer’s disease.
Enrollment for INTERCEPT-AD is now closed.
Acumen and ACU193
At Acumen, we are focused on developing novel targeted therapies for Alzheimer’s disease. We are currently testing ACU193, an investigational drug designed to bind to and remove toxic protein aggregates called amyloid-beta oligomers (AβOs) that build up in the brains of people with Alzheimer’s disease.
Trial Details
Acumen has initiated a first-in-human, Phase 1 clinical trial of ACU193 in early Alzheimer’s patients. This study, named INTERCEPT-AD, is a single ascending dose (SAD) and multiple ascending dose (MAD), placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous ACU193 when administered to participants diagnosed with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease (AD). The study also includes clinical assessments of memory and ability to perform daily activities.
For questions about Acumen’s ACU193 clinical trial, please email us at clinicaltrials@acumenpharm.com or call 463-235-7482
Informed Consent
It is important that clinical trial participants understand the journey they are embarking on. That is why clinical researchers will go through a process with them called informed consent. Informed consent ensures that potential trial participants are provided sufficient information about the clinical trial so they can understand the potential benefits, risks and possible alternatives to clinical trial participation. Informed consent is an important part of conducting ethical research and is there to protect participants. Your trial site coordinator will go through the informed consent process with you.
Why is the study called “INTERCEPT-AD”?
Acumen chose the name “INTERCEPT-AD” to reflect that ACU-193 is the first immunotherapy drug candidate to enter the clinic that targets – and intercepts – toxic amyloid-beta oligomers (AβOs), which a growing body of scientific evidence indicates are the most toxic form of amyloid and a primary underlying cause of the neurodegeneration in AD.
Who Can Participate?
You may qualify for the INTERCEPT-AD study if:
- If you have mild cognitive impairment due to AD or mild dementia due to AD
- You are aged 55-90 and weight at least 90 lbs and no more than 250 lbs
- If you are female, you are post-menopausal or have been surgically sterilized
- If you are male with a female partner of child-bearing potential, you must use contraception
To find the nearest trial site, you can visit the trial descriptor on clinicaltrials.gov. An investigator or trial site manager can help determine if you’re eligible for the study, explain how the study works, what is required of you, and what the risks and possible benefits may be.
Overview of ACU193 Science
ACU193 is designed to address an underlying cause of Alzheimer’s disease by binding to a toxic form of protein aggregates called amyloid-β-oligomers, or AβOs. Evidence indicates that AβOs are a primary trigger and persistent driver of Alzheimer’s associated pathology and neurodegeneration. The accumulation of AβOs is associated with deterioration and loss of the connections between nerves, as well as inflammation. There is evidence that this leads to memory impairment, cognitive decline and progressive neurodegeneration that are seen in Alzheimer’s disease.
By binding to AβOs, ACU193 prevents them from binding to specialized parts of nerves called dendritic spines. By binding to AβOs, ACU193 may help to preserve nerve function and protect cells from neurodegeneration.
Why Volunteer?
If you are living with AD, you know how this disease can impact your life and the lives of your loved ones, from managing day-to-day living, to understanding your long-term outlook. You and your family understand the need for new treatment options better than anyone.
Clinical trials are an important part of bringing new medicines to patients. A clinical trial is a research study designed to evaluate whether an investigational medicine is effective at addressing a particular disease, as well as the effect that potential treatment has on the patient. Data from clinical trials allow for regulators to determine if a drug is ready to be made available to patients broadly.
Patients are important partners in the journey toward developing new medicines, and their participation in clinical trials is invaluable.
People who choose to participate in a clinical trial may do so for a number of reasons:
- They may gain access to specialized diagnostic tests, investigational medicines, and excellent trial-related medical care at no additional cost to them.
- They hope to contribute to a better understanding of the disease and how AD affects the brain.
- They altruistically hope their contribution to advancing science and medicine will help future patients have better treatment options.
Frequently Asked Questions
How do I enroll in the study?
First you need to see if there are any study sites near you. You can do this by going to the INTERCEPT-AD page on ClinicalTrials.gov, a database of privately and publicly funded clinical studies conducted around the world. This resource is provided by the U.S. National Library of Medicine. Here is a link: INTERCEPT-AD at ClinicalTrials.gov. Our sites are listed at the bottom of the page, along with their contact information.
If there are no sites near you, you can search ClinicalTrials.gov for other studies near you. Your current health care provider may also know of clinical trials in your area.
What is expected of me and my loved ones? How often will I need to visit the trial site?
When you contact the study site, they will provide specific information regarding your eligibility for the study. Before deciding to participate in INTERCEPT-AD, you will be asked to review an informational document called an informed consent form. This form will provide key facts about the study, including the number of visits to the trial site, study procedures (such as MRI and assessments of your cognitive abilities) so that you can decide if participating is right for you and your loved ones.
Can I continue to see my current doctors?
If you are eligible for a clinical study and you decide to participate, you can and should continue to see your other doctors. The study doctor will manage activities related to the trial, and your current doctors will continue to care for you as they did previously.
Can I continue to take my medicines while participating in the trial?
Your medicines will be discussed during the informed consent process and the study staff will let you know which medicines are permitted and not permitted in INTERCEPT-AD.
Will I be reimbursed for my time or travel?
Reimbursement while in a clinical study is determined by how much time you have invested and inconveniences you may have experienced while participating in the clinical study. Typical expenses that are covered include travel to the site, meals during study visits and parking. In addition, the costs of all medical care and study procedures that are associated with the study are covered.
Will I be able to continue taking the investigational medicine after the trial is over?
INTERCEPT-AD is the first clinical study of ACU193. Because it is considered an investigational drug, it is not available to the public and is only available to clinical study participants. Additional clinical studies of ACU193 may be taking place after INTERCEPT-AD is complete and you can let your study doctor know if you are interested in being evaluated for eligibility for these studies at that time.
Can I learn about the results of the trial?
Your study doctor will not know whether you were receiving ACU193 or placebo until after the study has been completed. At that time, your study doctor can tell you whether you received ACU193 or placebo. Once the data from the study have been analyzed, results will be added to the INTERCEPT-AD page on ClinicalTrials.gov (INTERCEPT-AD at ClinicalTrials.gov). It is likely the results will also be published in a scientific journal.
