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ACTIVE NOT RECRUITING
NCT06489015
EARLY_PHASE1

Recombinant Human Serum Albumin in the Treatment of AD (Alzheimer Disease) Exploratory Clinical Trials

Sponsor: Protgen Ltd

View on ClinicalTrials.gov

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 Alzheimer's Disease (AD). It aims to enroll 30 subjects who meet the 2011 National Institute on Aging and Alzheimer's Association (NIA-AA) criteria for "Probable AD Dementia." Participants will be randomized in a 1:1:1 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.

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 Alzheimer's Disease

Key Details

Gender

All

Age Range

50 Years - 85 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2024-06-28

Completion Date

2026-12

Last Updated

2026-03-11

Healthy Volunteers

No

Interventions

DRUG

Recombinant Human Serum Albumin

Each group receives the investigational drug (recombinant human serum albumin), with the distinction being the variation in dosing.

Locations (5)

Luoyang Third People's Hospital

Luoyang, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Wuhan Union Hospital of China

Wuhan, Hubei, China

Clinical Medical College & Affiliated Hospital Of Jiujiang University

Jiujiang, Jiangxi, China

Shanghai Mental Health Center

Shanghai, Shanghai Municipality, China