Alzheimer's Disease (AD)Phase 1/2NCT06874621
VY7523-102: Randomized, Placebo-Controlled, Double-Blind, Multiple Ascending Dose Study in Participants With Early Alzheimer's Disease
A Phase 1/2 study testing VY7523 in people with Alzheimer's Disease (AD), run by Voyager Therapeutics at 23 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Alzheimer's Disease (AD)
- What is being tested?
- VY7523
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 23 sitesin 2 countries
- Study dates
- 3 Mar 2025to May 2027
- Phase
- Phase 1/2
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 50 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- 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:
- Evidence of Tau PET imaging agent uptake into the brain by central read AND
- Evidence of positive brain amyloid pathology as indicated by one of the following:
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- Documented historical amyloid PET showing imaging agent uptake into the brain conducted within 24 months before screening OR
- CSF beta amyloid and tau levels consistent with AD diagnosis within the Screening Period.
- Body mass index (BMI) ≥18 and ≤35 kg/m2 at Screening.
- Apart from the clinical diagnosis of early AD, participant must be in good health, based on medical history and screening assessments.
- If participant is receiving an approved symptomatic AD treatment such as but not limited to acetylcholinesterase inhibitor (AChEIs), memantine, rivastigmine, galantamine and tacrine for AD, participant must be on a stable dose for at least 8 weeks prior to Screening.
- Treatment-naive participants for AD can be entered into the study.
- Unless otherwise stated, participants must have been on stable doses of all other (non-AD-related) permitted concomitant medications for at least 4 weeks prior to Screening.
- Participants currently on β amyloid therapies may not be enrolled.
- Must have an identified reliable informant/caregiver (defined as a person able to support the participant for the duration of the study e.g., spouse, sibling, close friend, who spends at least 10 hours per week with the participant) who assented to:
- Accompany the participant to clinic visits.
- Provide information to study Investigator/staff about functioning, cognitive abilities and AEs.
- Support participants returning for per-protocol follow-up visits and procedures.
Who cannot join
- 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.
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- 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
- Any immunological disease which is not adequately controlled, or which requires treatment with immunoglobulins, systemic mAbs (or derivatives of mAbs), systemic immunosuppressants, or plasmapheresis during the study.
- History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).
- Participation in a clinical drug trial or device within 30 days (or 5 half-lives, whichever is longer and 3 months for a biologic) of screening, unless the study blind has been broken and the participant was known to be on placebo.
- Last administration of B-secretase and gamma-secretase inhibitors in a study within 3 months or 5 half-lives (whichever is longer) prior to screening, unless it can be documented that the participant only received placebo.
- Current use of an approved AD disease modifying or anti-amyloid therapy (including but not limited to any mAb therapies).
- Presence of risk for increased or uncontrolled bleeding and/or risk of bleeding that is not managed optimally and could place a participant at an increased risk for intraoperative or postoperative bleeding.
Trial locations and contacts
23 sites in 2 countries.
23 sites in 2 countries
United States19 sites
VYGR Site 840007
Decatur, Georgia, 30030
VYGR Site 840005
Delray Beach, Florida, 33445
VYGR Site 840021
Fort Myers, Florida, 33912
VYGR Site 840010
Lady Lake, Florida, 32159
VYGR Site 840018
Los Angeles, California, 90033
VYGR Site 840009
Matthews, North Carolina, 28105
VYGR Site 840015
Miami, Florida, 33126
VYGR Site 840014
Miami, Florida, 33135
VYGR Site 840024
Miami, Florida, 33137
VYGR Site 840016
Orange, California, 92866
VYGR Site 840006
Orlando, Florida, 32803
VYGR Site 840011
Plymouth Meeting, Pennsylvania, 19462
VYGR Site 840022
San Francisco, California, 94158
VYGR Site 840008
Stamford, Connecticut, 06905
VYGR Site 840003
Stuart, Florida, 34997
VYGR Site 840004
The Villages, Florida, 32162
VYGR Site 840012
Toms River, New Jersey, 08755
VYGR Site 840002
Wellington, Florida, 33414
VYGR Site 840020
Winter Park, Florida, 32789
Canada4 sites
VYGR Site 124003
Montreal, Quebec, H3G1H9
VYGR Site 124004
Montreal, Quebec, H4A3T2
VYGR Site 124002
Ottawa, Ontario, K1Z1G3
VYGR Site 124001
Toronto, Ontario, M3B2S7
About this study
Official title: VY7523-102: A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Ascending Intravenous Doses of VY7523 in Participants With Early Alzheimer's Disease
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.
- Conditions
- Alzheimer's Disease (AD)
- Being tested
- VY7523, Placebo Comparator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VY7523Drug
VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau
Placebo ComparatorDrug
Matching placebo to VY7523
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 active | Experimental | Low dose VY7523 Receives: Drug: VY7523 |
| Cohort 1 placebo | Placebo comparator | VY7523 matching placebo for Cohort 1 active dose Receives: Drug: Placebo Comparator |
| Cohort 2 active | Experimental | mid dose VY7523 Receives: Drug: VY7523 |
| Cohort 2 placebo | Placebo comparator | VY7523 matching placebo for Cohort 2 active dose Receives: Drug: Placebo Comparator |
| Cohort 3 active | Experimental | high dose VY7523 Receives: Drug: VY7523 |
| Cohort 3 placebo | Placebo comparator | VY7523 matching placebo for Cohort 3 active dose Receives: Drug: Placebo Comparator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Characterization of the safety and tolerability of VY7523 in participants with early AD
Incidence of treatment-emergent adverse events (TEAEs) and clinically significant changes from baseline
Measured: Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months
Secondary outcomes (4)
To characterize the pharmacokinetics (PK) of VY7523 in serum
- Serum VY7523 concentrations
Measured: Cohort 1 & 2: Month 1 - 6 Cohort 3: Month 1-7, 9, 12
To evaluate the ability of VY7523 to prevent the spread of pathologic tau; Cohort 3 only
Changes from baseline in the standardized uptake value ratio (SUVR) using tau-positron emission tomography (PET)
Measured: Month 6, 12
To evaluate the immunogenicity of multiple, escalating intravenous (IV) doses of VY7523
Incidence and level of treatment emergent anti-drug antibodies to VY7523
Measured: Cohort 1 & 2: Month 1, 3, 4, 5 & 6 Cohort 3: Month 1, 2, 6, 9, 12
To characterize the pharmacokinetics (PK) of VY7523 in cerebrospinal fluid (CSF) concentrations following multiple IV doses
VY7523 CSF concentrations
Measured: Cohort 1 & 2: Month 6 Cohort 3: Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2025
- Study start3 Mar 2025
- Primary completion13 Oct 2026
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's Disease (AD)Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 52 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Voyager Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Chief Medical Officer, Study director, Voyager Therapuetics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06874621
- Sponsor's protocol ID
- VY7523-102
- Status last verified
- Oct 2026
- First submitted
- 4 Mar 2025
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No