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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 active | Experimental | Low dose VY7523 |
|
| Cohort 1 placebo | Placebo Comparator | VY7523 matching placebo for Cohort 1 active dose |
|
| Cohort 2 active | Experimental | mid dose VY7523 |
|
| Cohort 2 placebo | Placebo Comparator | VY7523 matching placebo for Cohort 2 active dose |
|
| Cohort 3 active | Experimental | high dose VY7523 |
|
| Cohort 3 placebo | Placebo Comparator | VY7523 matching placebo for Cohort 3 active dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VY7523 | Drug | VY7523 is a recombinant humanized immunoglobulin gamma 4 (IgG4) monoclonal antibody targeting human pathological tau |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Cohorts 1 and 2: up to 6 months Cohort 3: up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| To characterize the pharmacokinetics (PK) of VY7523 in serum | • Serum VY7523 concentrations | 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 |
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Inclusion Criteria:
Clinical diagnosis of early AD, defined as:
Evidence of pathology consistent with AD diagnosis:
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:
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.
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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Voyager Therapuetics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VYGR Site 840018 | Los Angeles | California | 90033 | United States | ||
| VYGR Site 840016 |
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| Placebo Comparator | Drug | Matching placebo to VY7523 |
|
Changes from baseline in the standardized uptake value ratio (SUVR) using tau-positron emission tomography (PET)
| 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 | 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 | Cohort 1 & 2: Month 6 Cohort 3: Month 12 |
| Orange |
| California |
| 92866 |
| United States |
| VYGR Site 840022 | San Francisco | California | 94158 | United States |
| VYGR Site 840008 | Stamford | Connecticut | 06905 | United States |
| VYGR Site 840005 | Delray Beach | Florida | 33445 | United States |
| VYGR Site 840021 | Fort Myers | Florida | 33912 | United States |
| VYGR Site 840010 | Lady Lake | Florida | 32159 | United States |
| VYGR Site 840015 | Miami | Florida | 33126 | United States |
| VYGR Site 840014 | Miami | Florida | 33135 | United States |
| VYGR Site 840024 | Miami | Florida | 33137 | United States |
| VYGR Site 840006 | Orlando | Florida | 32803 | United States |
| VYGR Site 840003 | Stuart | Florida | 34997 | United States |
| VYGR Site 840004 | The Villages | Florida | 32162 | United States |
| VYGR Site 840002 | Wellington | Florida | 33414 | United States |
| VYGR Site 840020 | Winter Park | Florida | 32789 | United States |
| VYGR Site 840007 | Decatur | Georgia | 30030 | United States |
| VYGR Site 840012 | Toms River | New Jersey | 08755 | United States |
| VYGR Site 840009 | Matthews | North Carolina | 28105 | United States |
| VYGR Site 840011 | Plymouth Meeting | Pennsylvania | 19462 | United States |
| VYGR Site 124002 | Ottawa | Ontario | K1Z1G3 | Canada |
| VYGR Site 124001 | Toronto | Ontario | M3B2S7 | Canada |
| VYGR Site 124003 | Montreal | Quebec | H3G1H9 | Canada |
| VYGR Site 124004 | Montreal | Quebec | H4A3T2 | Canada |