An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease

Korábbi kezelés

• 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).
• Contraindications to lumbar puncture, MRI imaging, PET imaging or corticosteroids.
• History within 1 year prior to screening of drug or alcohol abuse.
• 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..

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• 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.
• 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.
• History of, or positive test result for human immunodeficiency virus (HIV), hepatitis C or current acute hepatitis B.
• History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).

• 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.