Actively Recruiting
Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
Led by Yonsei University · Updated on 2024-10-02
60
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
Sponsors
Y
Yonsei University
Lead Sponsor
S
Samjin Pharmaceutical Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a phase 2a, single-center, double-blind and randomized clinical trial that evaluates the safety and efficacy of AR1005 administration in 60 patients with cognitive impairment due to Lewy body disease. The study evaluates whether the administration of AR1005 in patients with cognitive impairment due to Lewy body disease has the effect of improving cognitive function, behavioral psychological symptoms, cognitive fluctuations, movement, brain waves and brain activity.
CONDITIONS
Official Title
Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and women over 60 years old
- Able to communicate in Korean and fully understand and agree to the study purpose and process
- Total score of 26 points or less on the Korean Mini-Mental State Examination (K-MMSE)
- Clinical Dementia Rating (CDR) total score of 0.5 or higher
- Medical history, neurological and hematologic exams, Seoul neuropsychological exam, and brain MRI indicating cognitive impairment due to Lewy body dementia
- Diagnosis meeting 2017 Dementia with Lewy Bodies Consortium (DLBC) guidelines for probable dementia with Lewy bodies or probable mild cognitive impairment with Lewy bodies
- Presence of dementia with noticeable defects in attention, executive function, and visuospatial abilities
- Presence of core clinical features such as cognitive fluctuation, visual hallucinations, Parkinson's syndrome, or REM sleep behavior disorder
- Presence of indicative biomarkers including decreased dopamine transporter uptake on PET, reduced [I-123]-MIBG myocardial scintigraphy uptake, or REM sleep behavior disorder confirmed by polysomnography
- Patients have a caregiver in regular contact spending at least 8 hours weekly
- Patients able to walk or move with aids
- Patients with sufficient vision, hearing, language, motor skills, and comprehension to follow study procedures (aids allowed)
- Voluntary participation with written consent from participant and legal representative
You will not qualify if you...
- Presence of other causes of cognitive decline such as neurosyphilis, thyroid disorders, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage or infarction, or Wernicke's encephalopathy based on tests within 6 months
- History or suspected allergy to AR1005-KRP2-01
- Current use of antistatic medications
- Inability to undergo brain MRI (unless MRI taken within one year is available)
- Employment or immediate family member involvement in the clinical study making participation difficult
- History of major psychiatric disorders including major depressive disorder, schizophrenia, or schizoaffective disorder
- Inability to perform an electroencephalogram
- Current use of acetylcholinesterase inhibitors other than rivastigmine or using rivastigmine patches (must switch to oral rivastigmine to participate)
- Moderate to severe liver disease (Child-Pugh grade B) or end-stage renal disease requiring dialysis
- Previous discontinuation due to aseptic meningitis related to AR1005-KRP2-01
- Genetic conditions such as galactose intolerance, lactase deficiency, or glucose-galactose malabsorption
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
Research Team
J
Jung Lim Lee
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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