An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
An Open Label Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of VY1706 in Participants With Early Alzheimer's Disease
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 30 Years to 80 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
Not stated in the study description — ask the study team about visits and procedures.
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests VY1706 in people with early Alzheimer’s disease. It is the first study of VY1706 in humans and tests increasing doses at several study sites.
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 55–80 years old, or 30–80 with a documented inherited gene change that causes Alzheimer’s disease.
- You have mild memory and thinking problems due to Alzheimer’s, or mild Alzheimer’s disease. Your MMSE thinking test score is 18–30 and your CDR disease rating is 0.5–1.
- Tests show amyloid and tau protein changes that support an Alzheimer’s diagnosis.
- The study doctor finds you in good health apart from early Alzheimer’s.
- If you take approved medicine for Alzheimer’s symptoms, your dose has stayed the same for at least 8 weeks before screening and stays the same through Day 1.
- All other medicine doses have stayed the same for at least 4 weeks before screening and stay the same through Day 1.
- You have a reliable study partner.
Who can't join
- You have another condition that could affect thinking, study results, safety, or your ability to finish the study. This includes a serious uncontrolled illness or a history of major heart or blood vessel disease.
- Screening finds anti-AAV9 antibodies, which are immune proteins that react to a virus called AAV9.
- You had a stroke, mini-stroke, or unexplained loss of consciousness in the past year; seizures in the past 10 years; or an epilepsy disorder. Childhood seizures caused by fever are allowed.
- You cannot safely have a spinal tap, MRI or PET scan, or take corticosteroid medicines.
- You have a history of or a positive test for HIV or hepatitis C, or you currently have acute hepatitis B.
- You had drug or alcohol abuse in the past year, severe allergies, or a severe allergic reaction called anaphylaxis. Hay fever that is not active is allowed.
- You have used an approved Alzheimer’s treatment meant to change the course of the disease, rather than just treat symptoms.
- You have joined a trial of cell or gene therapy, treatments targeting amyloid or tau, certain antibody or immune-protein treatments, gene-message treatments, or other treatments meant to change Alzheimer’s disease. This does not apply if records show you received only a placebo, a treatment with no active study drug.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
Inclusion Criteria: * Male or female participants aged 55 to 80 years (inclusive) at Screening or aged 30 to 80 years (inclusive) if presence of a historically documented dominantly inherited mutation associated with monogenic AD. * Clinical diagnosis of mild cognitive impairment (MCI) due to AD or mild AD with MMSE 18-30 and CDR Global score of 0.5-1. * Evidence of amyloid and tau pathology consistent with AD diagnosis by both: * Apart from the clinical diagnosis of early AD, participant must be in good health as determined by the Investigator. * If the participant is receiving an approved symptomatic AD treatment, such as acetylcholinesterase or NMDA inhibitors, the participant must be on a stable dose for at least 8 weeks prior to Screening and until Day 1. * Stable doses of all other (non-AD-related) concomitant medications for at least 4 weeks prior to Screening and until Day 1. * Must have an identified reliable Study Partner. Exclusion Criteria: Any medical or neurological/neurodegenerative or psychiatric condition (other than AD) that may be a 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. * Seropositive for anti-AAV9 antibodies at Screening. * 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). * Presence of a clinically significant uncontrolled medical disorder that may compromise the participant's safety or their ability to complete all of the study assessments. * History of significant cardiovascular disease. * Contraindications to lumbar puncture, MRI imaging, PET imaging or corticosteroids. * History of, or positive test result for human immunodeficiency virus (HIV), hepatitis C or current acute hepatitis B. * History within 1 year prior to screening of drug or alcohol abuse. * History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable). * Previous or current use of an approved AD disease-modifying therapies * Previous or current participation in a clinical study involving any cell or gene therapies (including but not limited to AAV-based gene therapies) or active immunotherapies targeting Tau or amyloid, or any anti-amyloid or anti-Tau therapies or any therapeutic mAb, protein derived from a mAb, immunoglobulin therapy, antisense oligonucleotides, small interfering ribonucleic acid, or any other agent with purported disease-modifying effect in AD unless it can be documented that the participant only received placebo..
Study sites (1)
FL
- K2 Medical Research, LLC · Maitland, FL 32751Recruitment Coordinator · Study contact · 407-676-5252More trials in Maitland