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To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia

NCT03413384 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-09-19

No results posted yet for this study

Summary

This is a randomized, double blinded, placebo-controlled Phase II study to investigate the efficacy and safety of ceftriaxone in patients with mild to moderate Parkinson's disease dementia (PDD).This study will enroll approximately 106 patients to have up to 84 evaluable subjects, and conduct in Chung Shan Medical University Hospital, National Taiwan University Hospital, Kaohsiung Chang Gung Memorial Hospital, China Medical University Hospital, Changhua Christian Hospital, and Taipei Veterans General Hospital.

Conditions

  • Parkinson's Disease Dementia

Interventions

DRUG

Ceftriaxone

1 g ceftriaxone per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle

OTHER

Placebo

Placebo per day for Day 1, 3, and 5 per cycle on a 2 weekly cycle

Sponsors & Collaborators

  • Virginia Contract Research Organization Co., Ltd.

    collaborator OTHER

  • BrainX Corporation

    lead INDUSTRY

Principal Investigators

  • Joshua Ho · China Medical University, China

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-15
Primary Completion
2025-07-28
Completion
2025-12-31
FDA Drug
Yes

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03413384 on ClinicalTrials.gov