Ignite Creation Date:
2024-07-17 @ 10:41 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06489015
Status:
RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-06-26
Brief Title:
Recombinant Human Serum Albumin in the Treatment of AD Alzheimer Disease Exploratory Clinical Trials
Sponsor:
Protgen Ltd
Organization:
Protgen Ltd
Study Overview
Official Title:
An Open-label Parallel-group Exploratory Clinical Trial to Evaluate the Safety and Preliminary Efficacy of Recombinant Human Serum Albumin Injection in the Treatment of Mild to Moderate Alzheimers Disease
Status:
RECRUITING
Status Verified Date:
2024-07
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 clinical trial is an open-label parallel-group exploratory study of recombinant human serum albumin rHSA hereafter referred to as the investigational drug in patients with mild to moderate Alzheimers Disease AD It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimers Association NIA-AA criteria for Probable AD Dementia Participants will be randomized in a 111 ratio to receive the investigational drug at doses of 20g 30g or 40g for assessments of safety and preliminary efficacy Stratification factors will be based on the severity classification mild moderate as indicated by the total score on the Clinical Dementia Rating Scale - Global Score CDR-GS during the screening period
Detailed Description:
None
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