VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Partic… (NCT06874621) | Clinical Trial Compass
Active — Not RecruitingPhase 1/2
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
United States, Canada52 participantsStarted 2025-03-03
Plain-language summary
This study is to be conducted in participants with early Alzheimer's Disease to test VY7523, a new drug being researched for treatment of Alzheimer's Disease. This study will look at how safe the drug is and how it works in the brain. It was first tested in normal, healthy participants who volunteered to participate. The study will look at three different dose levels, starting with the lowest dose first and moving to higher doses and more participants after safety has been reviewed by doctors and researchers. Some patients will receive drug while others will receive placebo. This will help to better compare how the drug works between participants receiving drug and placebo. The study will last up to 6 months for the lower dose groups and 12 months for the highest dose group.
Who can participate
Age range
50 Years – 90 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Clinical diagnosis of early AD, defined as:
. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD.
. Mini Mental State Examination (MMSE) score between 18 and 30, inclusive, at Screening (Cohort 1 and 2) and score between 22 and 30, inclusive, at Screening (Cohort 3).
. Report a history of subjective memory decline with gradual onset and slow progression over at least the last 6 months before Screening; must be corroborated by an informant/caregiver.
. CDR Memory Box score ≥0.5 CDR global score of 0.5 for MCI due to AD or 0.5 or 1 for mild AD.
. Evidence of pathology consistent with AD diagnosis:
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1/2 trial primarily focused on testing the safety and tolerability of VY7523 rather than proving it works, what does that mean for what we'd actually learn from me participating — and how does that compare to the benefit I might get from standard treatments available right now?
2The trial is listed as 'active, not recruiting,' which means they're no longer accepting new participants — does that mean this specific study is completely off the table for me, or is there a waitlist or a follow-up phase that might open up?
3Since this is a 'multiple ascending dose' study, participants are likely receiving increasing amounts of the drug over time — how would my doctor monitor me for side effects during that process, and what kinds of safety concerns have come up with similar experimental Alzheimer's treatments?
4Because this trial is randomized and placebo-controlled, there's a real chance I could be assigned to the placebo group and not receive the experimental drug at all — how should I weigh that possibility against pursuing other options, especially given that my diagnosis is described as 'early' Alzheimer's?
5Are there other active clinical trials studying treatments for early Alzheimer's disease that might be recruiting right now, and how does VY7523 compare to what else is being tested in terms of what's already known about safety?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Characterization of the safety and tolerability of VY7523 in participants with early AD
Timeframe: Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months
. For Cohort 1 and Cohort 2 only, by documented historical amyloid PET showing imaging agent uptake into the brain conducted within 24 months before screening OR elevated plasma pTau217/np-Tau217 ratio within the Screening Period.
. For Cohort 3 only, evidence of pathology consistent with AD diagnosis by both:
Exclusion criteria
. Any medical or neurological/neurodegenerative or psychiatric condition (other than AD) that, in the opinion of the Investigator, may be contributing cause to cognitive impairment or could confound interpretation of drug effect, affect study assessments, or affect participant's ability to participate and complete the study or lead to safety concerns.
. History of transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
. History of seizures within 10 years prior to screening or history of epileptic syndrome (except for history of febrile seizures in childhood)
. Lifetime history of a major psychiatric disorder including schizophrenia or bipolar disorder. History of major depressive disorder that has resulted in 2 or more hospitalizations in a lifetime.
. Presence of a clinically significant uncontrolled medical disorder involving one or more of these major organ systems: cardiovascular (including but not limited to a QTcF of \>470 ms for women and \>450 ms for men and uncontrolled hypertension), respiratory, renal, gastrointestinal, immunologic, hematologic including bleeding disorder, hepatic, or endocrine.
. Contraindications to lumbar puncture, including but not limited to coagulation or bleeding disorders, unsafe suspension of anticoagulant, infections at the injection site, spinal deformities or previous spinal surgeries that may affect safe LP performance, or conditions associated with increased intracranial pressure.
. Contraindications to MRI scanning, including but not limited to cardiac pacemaker/defibrillator, ferromagnetic metal implants (devices other than those approved as safe for use in MRI scanners).
. History of a malignant disease (cancer) except for resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, in situ prostate cancer with a normal posttreatment prostate-specific antigen within the last five years or other cancers in remission for at least 5 years