Skip to content
TrialMatch
Sign up
Recruiting Phase 1

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

Create a profile to match View the full record on ClinicalTrials.gov

About this study

VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study

Condition
Alzheimer s Disease
Tested
VY1706 Low dose, VY1706 Mid dose, VY1706 High Dose, Anti-AAV9 Total Antibody (TAb) Assay
Sponsor
Voyager Therapeutics

Who can join

Age
30 to 80 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 30 years
  • Maximum age: 80 years
  • Study condition: Alzheimer s Disease
  • 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 12

  • 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..

Where

1 site, 1 recruiting

K2 Medical Research, LLC

Maitland, Florida, United States

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.