Alzheimer's Disease (AD) / Recombinant Human Serum Albumin · Phase EARLY_PHASE1 Trial

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

ClinicalTrials.gov · August 19, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a completed early-phase exploratory clinical trial of recombinant human serum albumin in mild to moderate Alzheimer's disease, registered but with no results posted in this registry record. The study was open-label and evaluated primarily for adverse events over 29–41 weeks.

What was studied

Early Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose. Alzheimer's Disease (AD); age from 50 Years; to 85 Years. Intervention: 20g dose group; 30g dose group; 40g dose group. n = 30. 5 sites: China.

Key findings

Safety

Primary outcome is adverse events only; no efficacy endpoints are listed. Enrollment is small (n=30) and appropriate only for safety assessment in early phases.

Who this may help

This registry record does not report efficacy or safety outcomes, only study design and enrollment. Clinicians should await peer-reviewed publication of results to assess whether recombinant human serum albumin warrants further development.

Plain-language summary

Early-phase exploratory study with safety as primary outcome; no efficacy results reported in this registry record.

Study design

As stated by the source record.

MethodsPrimary outcome measure: Adverse Events (assessed at About 29 weeks or 41 weeks（It depends on whether the participant enters the ext…)

DesignEarly Phase 1, Interventional, Randomized, Parallel, Open label, Treatment purpose

PopulationAlzheimer's Disease (AD); age from 50 Years; to 85 Years

Sample size30

Intervention20g dose group; 30g dose group; 40g dose group

Setting5 sites: China

Reported figures

Quoted from the source exactly as published.

Planned enrollment30

PhaseEARLY_PHASE1

Primary outcome measureAdverse Events

Planned follow-up duration29 weeks or 41 weeks (depending on extension period)

Clinical bottom line

Caveats

No results are reported in this registry record; outcomes must be obtained from published literature or future updates.
Open-label design without control arm limits ability to attribute any observed effects to the intervention.
Primary outcome is adverse events only; no efficacy endpoints are listed.
Enrollment is small (n=30) and appropriate only for safety assessment in early phases.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

limited

Open-label, parallel-group exploratory design without control arm.

Directness

moderate

Directly tests intervention in target population but measures only safety.

Consistency

insufficient

Single study; no comparative or prior efficacy data reported.

Risk of bias

limited

Open-label design without blinding introduces bias risk.

Sample adequacy

limited

30 participants total; appropriate for exploratory phase but underpowered for efficacy.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT06489015). This is a study registration, not published results. Lead sponsor: Protgen Ltd. Recruitment status: COMPLETED. Phase: EARLY_PHASE1. Study type: INTERVENTIONAL. Enrollment: 30 participants (ACTUAL). Conditions: Alzheimer's Disease (AD). Interventions: DRUG: Recombinant Human Serum Albumin. Primary outcome measures: Adverse Events , About 29 weeks or 41 weeks（It depends on whether the participant enters the extention treatment period）. Brief summary: This clinical trial is an open-label, parallel-group, exploratory study of recombinant human serum albumin in patients with mild to moderate Alzheimer's Disease (AD).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

ProtgenNCT06489015Alzheimer's Disease (AD)Recombinant Human Serum Albumin