Health TrialsbyHealthPanel

The Effect of CB-Exo-A600 in Mild to Moderate Alzheimer's Disease

ConditionMild to Moderate Alzheimer's Disease
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorXuanwu Hospital, Beijing

About this trial

This study is divided into two phases: a dose-escalation phase and an expansion cohort phase. The dose-escalation phase is a single-center study, while the expansion cohort phase is a multicenter, prospective, randomized, double-blind, placebo-controlled study.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 years, male or female.

Clinical diagnosis of AD (mild to moderate stage, corresponding to clinical stage 4-5 at screening according to the 2024 National Institute on Aging/Alzheimer's Association [NIA/AA] criteria).

Patients with cerebrospinal fluid biomarker data supporting an AD diagnosis within the past 3 years, or a positive amyloid Positron Emission Tomography (PET) scan result within the past 3 years, or a plasma p-tau217 test result indicating brain amyloid positivity.

Magnetic Resonance Imaging (MRI) or Computed Tomography (CT) scan performed within 6 months prior to screening shows findings consistent with the clinical diagnosis of mild to moderate AD and no other clinically significant comorbid pathologies, particularly cerebrovascular disease. If an MRI or CT scan is not available within the 6 months prior to screening, an MRI must be completed and results confirmed before the subject initiates treatment.

Disqualifiers

Patients with a known allergic reaction to the investigational drug or similar drugs.

Patients with a known allergic constitution.

Previous receipt of umbilical cord mesenchymal stem cell therapy.

Laboratory findings (any of the following): absolute neutrophil count < 1.0 × 10⁹/L, platelet count < 100 × 10⁹/L, serum creatinine > upper limit of normal range, serum total bilirubin, alanine aminotransferase, or aspartate aminotransferase > 2 × upper limit of normal range.

Trial design

Design model

Sequential

Treatments tested in this trial

  • Exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop

    Drug

    Specification: 2.0 mL/vial. Particle concentration: (Low) 0.75 × 10¹⁰ Particles/mL, (Medium) 1.50 × 10¹⁰ Particles/mL, (High) 3.00 × 10¹⁰ Particles/mL.

  • A placebo of exosomes derived from umbilical cord mesenchymal stem cell for intranasal drop

    Drug

    Specification: 2.0 mL/vial.

Treatment groups

33 Participants
are divided into 2 treatment groups
Group A: Exosomes groupExperimental treatment 1 intervention
Group B: Exosomes placebo groupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of serious adverse events

The proportion of patients who experienced severe adverse events.

Time frame
24 weeks (±1 week)

Secondary outcomes

1

Alzheimer's Disease Assessment Scale-cog

Change from baseline in the Alzheimer's Disease Assessment Scale - Cognitive subscale (ADAS-cog) score

Time frame
24 weeks (±1 week）
2

Incidence of adverse events

The proportion of patients who experienced adverse events.

Time frame
24 weeks (±1 week)
3

Incidence of severe adverse events

The proportion of patients who experienced severe adverse events.

Time frame
12 weeks (±1 week)
4

Incidence of adverse events

The proportion of patients who experienced adverse events.

Time frame
12 weeks (±1 week)

Other outcomes

1

AD biomarkers

Change from baseline in blood-based AD biomarkers (Aβ42/40, P-Tau181, P-Tau217, NFL, GFAP, etc.)

Time frame
12 weeks (±1 week)
2

AD biomarkers

Change from baseline in blood-based AD biomarkers (Aβ42/40, P-Tau181, P-Tau217, NFL, GFAP, etc.)

Time frame
24 weeks (±1 week)
3

Proteomics and RNA sequencing molecular profiles

Change from baseline in peripheral blood proteomic and RNA sequencing molecular profiles

Time frame
12 weeks (±1 week)
4

Proteomic and RNA sequencing molecular profiles

Change from baseline in peripheral blood proteomic and RNA sequencing molecular profiles

Time frame
24 weeks (±1 week)

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Xuanwu Hospital, Beijing

Lead sponsor

Carrier Biomed (Suzhou) Co., Ltd

Collaborator

Institute of Process Engineering, Chinese Academy of Sciences

Collaborator

Source ClinicalTrials.gov
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