VG-3927 for Healthy Adults

No longer recruiting at 2 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Vigil Neuroscience, Inc.

Disqualifiers: Concurrent disease or condition

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called VG-3927, an experimental therapy, to assess its safety and behavior in the body. It primarily targets healthy adults, but includes a segment for individuals with Alzheimer's disease. The trial compares different doses of VG-3927, with some participants receiving a placebo, a harmless pill resembling the actual treatment. Participants must be healthy according to a medical evaluation and willing to join the study. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial is for healthy adults, it's possible that taking certain medications might affect your eligibility. It's best to discuss your specific situation with the trial organizers.

Is there any evidence suggesting that VG-3927 is likely to be safe for humans?

Research has shown that VG-3927 was generally well-tolerated in early trials. The safety data indicates that VG-3927 is suitable for further studies, as it did not cause serious short-term side effects. Ongoing studies continue to monitor safety, but the initial results are promising. Overall, VG-3927 appears safe enough for continued testing in humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Alzheimer's, which often focus on managing symptoms, VG-3927 offers a novel approach by potentially targeting the underlying disease processes. Current options like cholinesterase inhibitors and memantine work by trying to improve neurotransmitter function, but VG-3927 might work differently, which has researchers excited about its potential to change the course of the disease. Moreover, VG-3927 is being tested in an open-label format, which means researchers can closely observe its immediate impacts on participants, offering a clearer understanding of its effects compared to existing treatments.

What evidence suggests that VG-3927 might be an effective treatment for Alzheimer's?

Research has shown that VG-3927 could be a promising treatment for Alzheimer's disease. Early studies indicate that the body processes VG-3927 predictably, allowing for the possibility of once-daily dosing. In this trial, some participants will receive VG-3927 in single and multiple ascending doses, while others will receive a placebo. Tests with healthy volunteers showed strong results for VG-3927, encouraging further research. These initial findings suggest VG-3927 might be a good option for treating Alzheimer's disease, but more studies are needed to confirm its effectiveness. ^{3 5 6 7 8}

Are You a Good Fit for This Trial?

This trial is for healthy adults who have agreed to participate and signed a consent form. They must be considered healthy by the study's doctor, based on medical evaluations done before the study starts.

Inclusion Criteria

Participant voluntarily agrees to participate in this study and signs an institutional review board approved informed consent

Participant is deemed healthy by the principal investigator, as determined by prestudy medical evaluation

Exclusion Criteria

Participant has any concurrent disease or condition that, in the opinion of the principal investigator, would make the participant unsuitable for participation in the clinical study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive ascending single and multiple doses of VG-3927 or placebo, and Alzheimer's patients receive a single open-label dose

4 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VG-3927

Trial Overview

The trial is testing VG-3927, a new drug, in its first use in humans. Participants will either receive VG-3927 or a placebo (a substance with no active drug) to evaluate safety, how well it's tolerated, and how it affects and moves through the body.

How Is the Trial Designed?

Group I: Single and Multiple Ascending Dose Experimental Treatment 1 Intervention

Ascending single doses and multiple doses for healthy volunteers.

Group II: Alzheimer's Disease Experimental Treatment 1 Intervention

Single Dose Open-label

Group III: Placebo Placebo Group 1 Intervention

Matching placebo

Who Is Running the Clinical Trial?

Vigil Neuroscience, Inc.

Lead Sponsor

Trials

3

Recruited

200+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06343636

NCT06343636 | A Phase 1 Study of VG-3927 in Healthy ...

A Phase 1, First-in-human, Randomized, Double-blind, Placebo-controlled, Single and Multiple Ascending Dose Study in Healthy Adults and Open-label Single Dose ...

2.

globenewswire.com

globenewswire.com/news-release/2024/07/24/2917876/0/en/Vigil-Neuroscience-Announces-Interim-Data-from-its-Ongoing-Phase-1-Clinical-Trial-Evaluating-VG-3927-in-Healthy-Volunteers-Supporting-Continued-Development-in-Alzheimer-s-Disease.html

Vigil Neuroscience Announces Interim Data from its Ongoing

VG-3927 demonstrated a predictable PK profile that is supportive of once-daily dosing. In the SAD and MAD cohorts, VG-3927 achieved a robust and ...

3.

clinicaltrialsarena.com

clinicaltrialsarena.com/news/fda-lifts-hold-vigil-trial/

FDA lifts partial hold on Vigil Neuroscience's Phase I VG ...

In July this year, Vigil Neuroscience shared interim findings from the single- and multiple-ascending dose study of VG-3927 in healthy subjects.

4.

quiverquant.com

quiverquant.com/news/Vigil+Neuroscience+Advances+VG-3927+into+Phase+2+Trial+as+a+Promising+Once-Daily+Oral+Therapy+for+Alzheimer%27s+Disease+Following+Positive+Phase+1+Results

Vigil Neuroscience Advances VG-3927 into Phase 2 Trial ...

Vigil Neuroscience, Inc. announced positive Phase 1 clinical trial results for VG-3927, a potential once-daily oral therapy for Alzheimer's disease (AD).

5.

static1.squarespace.com

static1.squarespace.com/static/5f77665fce2a6e2e65763cf0/t/6720e0606adaef266e650a41/1730207841250/CTAD+2024+poster.pdf

and Multiple-Ascending Dose Study of a Novel Orally ...

VG-3927 in healthy volunteers (HVs) and individuals with AD. STUDY DESIGN. • This phase 1, randomized, double-blind, placebo-controlled, SAD ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06343636

NCT06343636 | A Phase 1 Study of VG-3927 in Healthy ...

Safety continues to be evaluated, and short-term adverse events are studied. ... A Phase 1 Study of VG-3927 in Healthy Adults and Patients With Alzheimer's ...

7.

finance.yahoo.com

finance.yahoo.com/news/vigil-neuroscience-reports-positive-data-120000246.html

Vigil Neuroscience Reports Positive Data from its Phase 1 ...

Safety, tolerability, pharmacokinetic, and pharmacodynamic profile supports continued development of VG-3927 as potential once-daily oral therapy for Alzheimer ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11956194/

Immune modulation to treat Alzheimer's disease - PMC

Vigil neuroscience announces interim data from its ongoing phase 1 clinical trial evaluating VG-3927 in healthy volunteers supporting continued ...