VY7523 for Alzheimer's Disease

Recruiting at 48 trial locations

Overseen By Voyager Therapeutics Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 1 & 2

Sponsor: Voyager Therapeutics

Compensation: Varies

Number of Visits: 9

Duration: 6 to 18 months

52 Participants Needed

Trial Summary

What is the purpose of this trial?

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 18 months for the highest dose group.

Research Team

Chief Medical Officer

Principal Investigator

Voyager Therapuetics, Inc.

Eligibility Criteria

This trial is for individuals with early Alzheimer's Disease. Participants should have a diagnosis of Alzheimer's and be in the initial stages of the disease. They must have previously tolerated similar studies well, if applicable.

Inclusion Criteria

Body mass index (BMI) ≥18 and ≤35 kg/m2 at Screening

Participant must be in good health based on medical history and screening assessments

Mini Mental State Examination (MMSE) score between 18 and 30 at Screening for Cohort 1 and 2, and between 22 and 30 for Cohort 3

Exclusion Criteria

Contraindications to lumbar puncture or MRI scanning

My immune system disease is not well-controlled or needs specific treatments.

I have had a stroke or unexplained fainting in the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive multiple ascending intravenous doses of VY7523 or placebo, with dose escalation based on safety reviews

6 to 18 months

Monthly visits for dose administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants in Cohort 3 are monitored for long-term effects and efficacy of the high dose

12 months

Visits at months 9, 12, 17, and 18

Treatment Details

Interventions

• VY7523

Trial Overview The study tests VY7523, a new potential treatment for Alzheimer's. It will compare different doses against a placebo to assess safety and brain function impact over 6 to 18 months, depending on the dose level.

Participant Groups

Group I: Cohort 3 active Experimental Treatment 1 Intervention

high dose VY7523

Group II: Cohort 2 active Experimental Treatment 1 Intervention

mid dose VY7523

Group III: Cohort 1 active Experimental Treatment 1 Intervention

Low dose VY7523

Group IV: Cohort 1 placebo Placebo Group 1 Intervention

VY7523 matching placebo for Cohort 1 active dose

Group V: Cohort 2 placebo Placebo Group 1 Intervention

VY7523 matching placebo for Cohort 2 active dose

Group VI: Cohort 3 placebo Placebo Group 1 Intervention

VY7523 matching placebo for Cohort 3 active dose

Who Is Running the Clinical Trial?

Voyager Therapeutics

Lead Sponsor

Trials

6

Recruited

110+