Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06432166
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-29
First Post:
2024-05-14
Brief Title:
2-Hydroxybenzylamine 2-HOBA Study in Early Alzheimers Patients
Sponsor:
MTI Biotech Inc
Organization:
MTI Biotech Inc
Study Overview
Official Title:
2-Hydroxybenzylamine 2-HOBA Phase 1b2a Proof-of Concept Dose-Finding Biomarker Study in Early Alzheimers Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
2-HOBA
Brief Summary:
Investigators propose a phase 1b2a randomized double-blind placebo-controlled parallel group dose finding and biomarker study to evaluate the safety tolerability and biomarker activity of 2-HOBA in 48 MCIAD participants Participants will be randomized 1111 to receive 250 500 750 mg 2-HOBA acetate TID or placebo for 16 weeks Blood and cerebral spinal fluid CSF will be collected to measure markers of protein modification by dicarbonyls IsoLGs- MDA pTau-181 YKL-40 and NF-L
Detailed Description:
This is a phase 1b2a randomized double-blind placebo-controlled parallel group dose finding and biomarker study to evaluate the safety tolerability and biomarker activity of 2-HOBA in 48 MCIAD participants Participants will be randomized 1111 to receive 250 500 750 mg 2-HOBA acetate TID or placebo for 16 weeks Blood and CSF will be collected to measure markers of protein modification by dicarbonyls IsoLGs- MDA pTau-181 YKL-40 and NF-L Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the study allowing for up to 25 dropout for the 16-week study
The primary aims of this project are to 1 Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain Investigators hypothesize that 16 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship 2 Evaluate whether 2-HOBA is safe for extended use in patients with early AD Investigators hypothesize that 2-HOBA will be safe and well tolerated through 16 weeks of use Tolerability will be assessed by monitoring symptoms adverse events vital signs ECG and safety labs during the study
The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers brain inflammation disease severity and cognitive performance
The primary aims of this project are to 1 Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain Investigators hypothesize that 16 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship 2 Evaluate whether 2-HOBA is safe for extended use in patients with early AD Investigators hypothesize that 2-HOBA will be safe and well tolerated through 16 weeks of use Tolerability will be assessed by monitoring symptoms adverse events vital signs ECG and safety labs during the study
The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers brain inflammation disease severity and cognitive performance
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRB 231544 | OTHER | VUMC IRB | None |
| RC-201910-2019696 | OTHER_GRANT | None | None |