Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
ConditionLewy Body Dementia
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorYonsei University
About this trial
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.
Eligibility criteria
Qualifiers
men and women over the age of 60
Communication in Korean is possible and the purpose and process of the study are fully understood and agreed
Total score of 26 points or less in the simplified mental health assessment (K-MMSE)
Dementia Clinical Evaluation Scale (CDR) Total score of 0.5 or higher
Disqualifiers
In hematologic and brain magnetic resonance imaging tests conducted within 6 months, other causes of cognitive decline such as neurosyphilis, hypo/hyper-throidism, metabolic encephalopathy, brain tumor, acute cerebral hemorrhage, acute cerebral infraction, and Wernicke's encephalopathy are suspected
Subjects who are or are suspected of having an irritable allergy to AR1005-KRP2-01
If you are already on antistatic medication
A person who cannot perform a brain magnetic resonance image (but if there is a brain magnetic resonance image taken within one year, the brain magnetic resonance image can be omitted)
Trial design
Treatments tested in this trial
- AR1005
- Placebo
- Rivastigmine 3 mg
Treatment groups
60 Participants
are divided into 2 treatment groupsSponsors and collaborators
Yonsei University
Lead sponsor
Samjin Pharmaceutical Co., Ltd.
Collaborator
AriBio Co., Ltd.
Collaborator
Source ClinicalTrials.gov