Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06519357
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
A Single-center Self-controlled Prospective Case Series Pilot Study to Assess the Effect of Lamivudine 3TC on Neurocognitive Impairment Biomarkers and Type-I IFN Interferon-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment MCI
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Single-center Self-controlled Prospective Case Series Pilot Study to Assess the Effect of Lamivudine 3TC on Neurocognitive Impairment Biomarkers and Type-I IFN Interferon-Stimulated Genes in the Plasma of Patients With Mild Cognitive Impairment MCI
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
To assess the ability of lamivudine to lower the levels of neurocognitive impairment biomarkers in the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period
To assess the incidence nature and severity of Treatment Emergent Adverse Events TEAE
To assess the incidence nature and severity of Treatment Emergent Adverse Events TEAE
Detailed Description:
To assess the ability of lamivudine to lower the levels of type-I IFN-stimulated genes in the plasma and cryopreserved PBMCs of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period
Exploratory objectives
To assess the ability of lamivudine to modify retrotransposons expression in cryopreserved PBMCs the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period
Exploratory objectives
To assess the ability of lamivudine to modify retrotransposons expression in cryopreserved PBMCs the plasma of patients with MCI and positive AD biomarkers in a 24 weeks-treatment period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None