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Gene Therapy

Gene Therapy for Alzheimer's Disease (LEADLTFU Trial)

Phase 1

Recruiting

Research Sponsored by Lexeo Therapeutics

Eligibility Criteria Checklist

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

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 260 weeks

Awards & highlights

LEADLTFU Trial Summary

This trial is testing a gene therapy for Alzheimer's disease in people who have two copies of the APOE4 gene. The long-term safety of the therapy will be studied, as well as its ability to change the APOE4 protein in the brain to the APOE2-APOE4 protein.

Who is the study for?

This trial is for individuals with Alzheimer's who have the APOE4 gene variant and previously received LX1001 gene therapy. They must not have any medical conditions that could increase risk during the study, and they agree to keep their personal medical data off social media until all related studies are complete.Check my eligibility

What is being tested?

The study is monitoring long-term safety of LX1001 gene therapy in treating Alzheimer's. It also looks at changes in brain markers like amyloid levels, tau proteins, and MRI scans to see if there's improvement in cognitive functions over time.See study design

What are the potential side effects?

While specific side effects aren't listed here, participants will be monitored for any long-term safety concerns arising from the previous LX1001 gene therapy treatment.

LEADLTFU Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 260 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~260 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 260 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of serious adverse events

Incidence of treatment emergent adverse events

LEADLTFU Trial Design

1Treatment groups

Experimental Treatment

Group I: Previously administered LX1001Experimental Treatment1 Intervention

This is a long-term follow-up study to evaluate the safety following LX1001, a gene therapy, for participants who are APOE4 homozygotes with clinical diagnoses varying from MCI or dementia due to AD who have previously received LX1001. Study LX1001-01 was designed to assess the safety of LX1001 at 3 ascending doses (1.4 × 1010, 4.4 × 1010, 1.4 × 1011 gene copy [gc]/mL CSF) as per droplet digital polymerase chain reaction methodology, with each group consisting of approximately n=5 individuals for a total of approximately 15 participants for the entire study. In this study, participants who have received LX1001 in the parent protocol (LX1001-01) will be followed for up to 260 weeks post gene therapy administration

Do I qualify?Apply below to find out

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Who is running the clinical trial?

Lexeo TherapeuticsLead Sponsor

3 Previous Clinical Trials

34 Total Patients Enrolled

Lexeo Clinical TrialsStudy DirectorLexeo Therapeutics

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

LX1001 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT05400330 — Phase 1

Alzheimer's Disease Research Study Groups: Previously administered LX1001

Alzheimer's Disease Clinical Trial 2023: LX1001 Highlights & Side Effects. Trial Name: NCT05400330 — Phase 1

LX1001 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05400330 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is enrollment available for this clinical exploration?

"According to the clinicaltrials.gov listing, this medical trial is not currently open for enrollment; it was initially posted on November 1st 2022 and last updated on October 13th 2022. Nonetheless, there are 546 other trials seeking participants at present."

Answered by AI