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VY7523 for Alzheimer's Disease

Los Angeles, CA

Phase 1 & 2

Recruiting

Research Sponsored by Voyager Therapeutics

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Evidence of pathology consistent with AD diagnosis by documented historical amyloid PET or elevated plasma pTau217/np-Tau217 ratio

Treatment-naive participants for AD can be entered into the study

Must not have

Presence of clinically significant uncontrolled medical disorder involving major organ systems

Immunological disease not adequately controlled or requiring specific treatments

Timeline

Screening 3 weeks

Treatment Varies

Follow Up cohort 1 & 2: month 1, 3, 4, 5 & 6 cohort 3: month 1, 2, 6, 9, 12 & 18

Summary

"This trial is testing a new drug, VY7523, on people with early Alzheimer's Disease. The study will determine the safety and effectiveness of the drug in the brain. The drug will be

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Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Specific side effects are not listed but generally may include reactions at the injection site, headaches, nausea or other symptoms that will be closely monitored given it’s an early-stage trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My tests show signs consistent with Alzheimer's disease.

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I have not received any treatment for Alzheimer's disease.

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I am not currently taking any β amyloid therapies.

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I have been diagnosed with early-stage Alzheimer's disease.

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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a serious health condition that is not under control.

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

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

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I have had seizures or epilepsy within the last 10 years.

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I am currently using medication for Alzheimer's disease.

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I am at risk for heavy or uncontrolled bleeding.

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I have been hospitalized twice or more for a major psychiatric or depressive disorder.

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Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ cohort 1 & 2: month 1, 3, 4, 5 & 6 cohort 3: month 1, 2, 6, 9, 12 & 18

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~cohort 1 & 2: month 1, 3, 4, 5 & 6 cohort 3: month 1, 2, 6, 9, 12 & 18

This trial's timeline: 3 weeks for screening, Varies for treatment, and cohort 1 & 2: month 1, 3, 4, 5 & 6 cohort 3: month 1, 2, 6, 9, 12 & 18 for reporting.