To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Di… (NCT03413384) | Clinical Trial Compass
Active — Not RecruitingPhase 2
To Assess the Efficacy and Safety of Ceftriaxone in Patients With Mild to Moderate Parkinson's Disease Dementia
Taiwan100 participantsStarted 2019-02-15
Plain-language 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.
Who can participate
Age range50 Years – 85 Years
SexALL
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Inclusion criteria
✓. Patients are male or female, age 50-85 years, inclusive.
✓. Diagnosis of idiopathic Parkinson's disease (PD) based on the UK Parkinson's Disease Society Brain Bank Criteria and with a modified Hoehn and Yahr Stage of I to IV.
✓. Patients have been receiving stable dose of medications equivalent up to 1800 mg/day of levodopa for Parkinson's disease at least 2 weeks prior to screening and patients are considered as being optimally treated at screening and no known further adjustments of current medication needed to improve the subject's status of PD during the study period by the judgment of the Investigator based on the subject's history, previous treatments, and the clinical presentation.
✓. Diagnosis of PDD based on Movement Disorder Society (MDS) Task Force criteria as the following items:
✓. A diagnosis of PD based on UK Parkinson's Disease Society Brain Bank Criteria
✓. PD development prior to the onset of dementia based on patient/caregiver history or records
✓. Cognitive deficiency severe enough to impair daily life based on patient/caregiver interview or questionnaire
✓. Impairment of at least 2 of the following domains: attention, executive function, visuo-constructive ability, memory Besides, patients' Mini-Mental State Examination (MMSE) should be in the range of 18-25 (inclusive) or CDR scale in the range of 0.5-2. Note that MMSE range 16-25 for illiterate. Illiterate is defined as no education history.
Exclusion criteria
✕. Any indication of forms of Parkinsonism other than idiopathic PD.
What they're measuring
1
Compare the treatment difference in mean net change in ADAS-Cog score with time course
✕. Mental/physical/social condition which could preclude performing efficacy or safety assessments.
✕. Medical history of brain or other clinically significant neurological/psychiatric disorders or injuries other than PD or PDD that would hinder or interfere the study safety or efficacy evaluation in the opinion of the Investigator.
✕. The patients have received neurosurgical intervention related to PD (e.g. deep brain stimulation (DBS), thalamotomy etc.) or are scheduled to do so during the trial period.
✕. The patients have history of allergic response to levodopa, ceftriaxone, cephalosporin class of drugs or ursodiol or lidocaine.
✕. Malignant neoplastic disease, either currently active or in remission for less than 1 year.