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Testing a new drug for early Alzheimer's Disease

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

Phase1; Phase2 Interventional Voyager Therapeutics · NCT06874621

This study is testing a new drug for early Alzheimer's Disease to see if it can improve brain function and is safe for people with this condition.

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Enrollment52 (estimated)
Ages50 Years to 90 Years
SexAll
SponsorVoyager Therapeutics Industry-sponsored
Locations25 sites (Los Angeles, California and 24 other locations)
Trial IDNCT06874621 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the safety and efficacy of VY7523, a new drug aimed at treating early Alzheimer's Disease. Participants diagnosed with early Alzheimer's will be randomly assigned to receive either the drug or a placebo in a double-blind manner. The study will assess the drug's effects on brain function and safety across multiple ascending doses, with the trial lasting up to 18 months for some participants. The initial phase involves a careful review of safety before increasing the dosage and participant numbers.

Who should consider this trial

Good fit: Ideal candidates are individuals diagnosed with early Alzheimer's Disease, specifically those with mild cognitive impairment or mild Alzheimer's.

Not a fit: Patients with advanced Alzheimer's Disease or those not meeting the specific diagnostic criteria will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with early Alzheimer's Disease.

How similar studies have performed: Other studies have shown promise in similar approaches for treating Alzheimer's Disease, but this specific drug is novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Clinical diagnosis of early AD, defined as:

   1. Meet the NIA-AA core clinical criteria for MCI due to AD or mild AD.
   2. 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).
   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.
   4. 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.
2. Evidence of pathology consistent with AD diagnosis:

   1. 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.
   2. 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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   1. Documented historical amyloid PET showing imaging agent uptake into the brain conducted within 24 months before screening OR
   2. CSF beta amyloid and tau levels consistent with AD diagnosis within the Screening Period.
3. Body mass index (BMI) ≥18 and ≤35 kg/m2 at Screening.
4. Apart from the clinical diagnosis of early AD, participant must be in good health, based on medical history and screening assessments.
5. 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.

   1. Treatment-naive participants for AD can be entered into the study.
   2. 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.
   3. Participants currently on β amyloid therapies may not be enrolled.
6. 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:

   1. Accompany the participant to clinic visits.
   2. Provide information to study Investigator/staff about functioning, cognitive abilities and AEs.
   3. Support participants returning for per-protocol follow-up visits and procedures.

Exclusion Criteria:

1. 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.
2. History of transient ischemic attack or stroke or any unexplained loss of consciousness within 1 year prior to Screening.
3. History of seizures within 10 years prior to screening or history of epileptic syndrome (except for history of febrile seizures in childhood)
4. 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.
5. 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.
6. 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.
7. 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).
8. 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
9. 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.
10. History of severe allergies, or history of an anaphylactic reaction (nonactive hay fever is acceptable).
11. 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.
12. 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.
13. Current use of an approved AD disease modifying or anti-amyloid therapy (including but not limited to any mAb therapies).
14. 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.

Where this trial is running

Los Angeles, California and 24 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
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Conditions Alzheimer&#39s Disease
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.