Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06594172
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase II Clinical Trial of of Early Application of Memantine and Pioglitazone to Protect Cognitive Function After Radiotherapy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
This clinical trial aims to evaluate the efficacy of early intervention with Memantine and Pioglitazone in preventing Radiation-Induced Brain Injury RIBI in patients undergoing cranial radiotherapy
RIBI a significant complication of radiation therapy for primary and metastatic brain tumors as well as head and neck cancers often presents with delayed and irreversible neurological damage severely affecting patients quality of life
Our previous studies have indicated that Memantine an NMDAR antagonist and Pioglitazone a PPAR-γ agonist play crucial roles in modulating the neuroprotective immune microenvironment by targeting key mechanisms of neuron-astrocyte fatty acid metabolism coupling These findings suggest that early administration of these drugs could protect cognitive function and reduce neuroinflammation in patients post-radiation
This prospective phase II clinical trial will assess the combined efficacy of Memantine and Pioglitazone in improving cognitive outcomes and preventing RIBI without adversely impacting the anti-tumor efficacy of radiation therapy The study will also explore the synergistic effects of these two FDA-approved drugs in early-stage RIBI prevention providing a new therapeutic strategy for enhancing the quality of life in cancer patients receiving radiotherapy
RIBI a significant complication of radiation therapy for primary and metastatic brain tumors as well as head and neck cancers often presents with delayed and irreversible neurological damage severely affecting patients quality of life
Our previous studies have indicated that Memantine an NMDAR antagonist and Pioglitazone a PPAR-γ agonist play crucial roles in modulating the neuroprotective immune microenvironment by targeting key mechanisms of neuron-astrocyte fatty acid metabolism coupling These findings suggest that early administration of these drugs could protect cognitive function and reduce neuroinflammation in patients post-radiation
This prospective phase II clinical trial will assess the combined efficacy of Memantine and Pioglitazone in improving cognitive outcomes and preventing RIBI without adversely impacting the anti-tumor efficacy of radiation therapy The study will also explore the synergistic effects of these two FDA-approved drugs in early-stage RIBI prevention providing a new therapeutic strategy for enhancing the quality of life in cancer patients receiving radiotherapy
Detailed Description:
None
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