Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06427668
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-05-13
Brief Title:
Study of SPG302 in Adult Participants With Mild-to-Moderate Alzheimers Disease AD
Sponsor:
Spinogenix
Organization:
Spinogenix
Study Overview
Official Title:
A Phase 2 Randomized Placebo-controlled Double-Blind Multicenter Study to Assess the Safety Tolerability and Pharmacodynamics PD in Adult Participants With Mild-to Moderate Alzheimers Disease AD Administered SPG302
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase 2 study will evaluate the safety tolerability clinical efficacy pharmacokinetics and pharmacodynamics of SPG302 in adult participants with mild-to-moderate AD
Detailed Description:
This is a phase 2 multicenter study to assess the safety tolerability CNS effects pharmacokinetics pharmacodynamics and clinical efficacy of SPG302 in adult participants with mild-to-moderate AD The study will consist of 2 parts
Part A Placebo-controlled randomized safety and preliminary efficacy cohort with daily dosing for 28 day cycles
Part B a randomized expansion cohort of daily dosing for 28 day cycles
Part A Placebo-controlled randomized safety and preliminary efficacy cohort with daily dosing for 28 day cycles
Part B a randomized expansion cohort of daily dosing for 28 day cycles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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