Alzheimer s DiseasePhase 1NCT07764146
An Open Label Dose Escalation Study of VY1706 in Participants With Early Alzheimer's Disease
A Phase 1 study testing VY1706 Low dose, VY1706 Mid dose and VY1706 High Dose in people with Alzheimer s Disease, run by Voyager Therapeutics at 2 sites in United States.
Trial summary
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Alzheimer s Disease
- What is being tested?
- VY1706 Low dose, VY1706 Mid dose and VY1706 High Dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2026to 28 Apr 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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..
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
K2 Medical Research, LLC
Maitland, Florida, 32751
Recruitment Coordinator, 407-676-5252
- Recruiting
AdventHealth Orlando
Orlando, Florida, 32803
Recruitment Coordinator, 407-609-9040, anita.fletcher.md@adventhealth.com
Anita Fletcher, MD
About this study
Official title: An Open Label Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of VY1706 in Participants With Early Alzheimer's Disease
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study
- Conditions
- Alzheimer s Disease
- Being tested
- VY1706 Low dose, VY1706 Mid dose, VY1706 High Dose, Anti-AAV9 Total Antibody (TAb) Assay
- Keywords
- MCI due to AD, Mild AD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VY1706 Low doseDrug
Low dose
VY1706 Mid doseDrug
Mid Dose
VY1706 High DoseDrug
High dose
Anti-AAV9 Total Antibody (TAb) AssayDevice
Anti-AAV9 Total Antibody (TAb) Assay
| Study group | Role | What they receive |
|---|---|---|
| Low dose IV Infusion | Experimental | Not described Receives: Drug: VY1706 Low dose; Device: Anti-AAV9 Total Antibody (TAb) Assay |
| Mid dose IV Infusion | Experimental | Not described Receives: Drug: VY1706 Mid dose; Device: Anti-AAV9 Total Antibody (TAb) Assay |
| High dose IV Infusion | Experimental | Not described Receives: Drug: VY1706 High Dose; Device: Anti-AAV9 Total Antibody (TAb) Assay |
What is being measured
The primary outcome is the main question the study is designed to answer.
To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurological exams and other safety measures
Incidence of treatment emergent adverse events, clinically significant changes from baseline in vital signs, physical and neurological exams, Columbia Suicide-Severity Rating Scale, Electrocardiogram, Clinical lab parameters and transthoracic echocardiogram
Measured: 52 weeks
Secondary outcomes (2)
To evaluate the effect of VY1706 on CSF biomarkers of Tau
Change in baseline in CSF biomarkers of Tau
Measured: 52 weeks
To evaluate the effect of VY1706 on Tau pathology
Change from baseline in the SUVR on Tau pathology
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2026
- Study start3 Sep 2026
- Primary completion28 Apr 2029 (estimated)
- Study completion28 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer s DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voyager Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07764146
- Sponsor's protocol ID
- VY1706-101
- Status last verified
- Oct 2026
- First submitted
- 4 Aug 2026
- Last updated
- 29 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label Dose Escalation Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of VY1706 in Participants With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT07764146
- Acronym / sponsor ID
- VY1706-101
- Conditions
- Alzheimer s Disease
- Keywords
- MCI due to AD, Mild AD
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Voyager TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- 3 Sep 2026 (actual)
- Primary completion
- 28 Apr 2029 (estimated)
- Study completion
- 28 Apr 2029 (estimated)
- First posted
- 13 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
VY1706 first in human study in early Alzheimer's Disease is a multicenter dose escalation study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose IV Infusion | Experimental | Drug: VY1706 Low dose, Device: Anti-AAV9 Total Antibody (TAb) Assay |
| Mid dose IV Infusion | Experimental | Drug: VY1706 Mid dose, Device: Anti-AAV9 Total Antibody (TAb) Assay |
| High dose IV Infusion | Experimental | Drug: VY1706 High Dose, Device: Anti-AAV9 Total Antibody (TAb) Assay |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VY1706 Low doseLow dose | Drug | Low dose IV Infusion |
| VY1706 Mid doseMid Dose | Drug | Mid dose IV Infusion |
| VY1706 High DoseHigh dose | Drug | High dose IV Infusion |
| Anti-AAV9 Total Antibody (TAb) AssayAnti-AAV9 Total Antibody (TAb) Assay | Device | High dose IV Infusion, Low dose IV Infusion, Mid dose IV Infusion |
Primary outcome
To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurological exams and other safety measures
Time frame: 52 weeks
Incidence of treatment emergent adverse events, clinically significant changes from baseline in vital signs, physical and neurological exams, Columbia Suicide-Severity Rating Scale, Electrocardiogram, Clinical lab parameters and transthoracic echocardiogram
2 secondary outcomes
To evaluate the effect of VY1706 on CSF biomarkers of Tau
Time frame: 52 weeks
To evaluate the effect of VY1706 on Tau pathology
Time frame: 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Alzheimer s Disease
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment
Active, not recruitingPhase 2
Effect of Equol Supplementation on Arterial Stiffness and Cognition in Healthy Volunteers
Arterial Stiffness, White Matter Lesions
Not yet recruitingObservational study
Chinese University-Alzheimer's Disease With Vascular and Other Co-pathology: Towards Actionable Neuro-Cognitive-Omic Evaluations (CU-ADVANCE)
Alzheimer s Disease, Mild Cognitive Impairment (MCI)
RecruitingObservational study
Development, Validation and Normative Data of the Italian Battery for the Recognition of Famous Faces (FAME)
Stroke, Alzheimer s Disease
RecruitingObservational study
Speech and Language Interventions for Italian People With PPA
Primary Progressive Aphasia(PPA)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VY1706 Low dose, VY1706 Mid dose and VY1706 High Dose in people with Alzheimer s Disease, run by Voyager Therapeutics at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Voyager (857-259-5340, clinicaltrials@vygr.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To characterize the safety and tolerability in participants with AD by Incidence of treatment emergent adverse events, changes from baseline in vital signs, physical and neurological exams and other safety measures (time frame: 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.