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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

AR1005
Drug
AR1005 inhibits sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate.
Placebo
Drug
Matching placebo for AR1005 to be administered BID for 20 weeks
Rivastigmine 3 mg
Drug
3mg Rivastigmine will be administered BID for both active and placebo groups

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: ExperimentalExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20

The CDR-SOB score ranges from 0 to 18, with 0 indicating no dementia symptoms and 18 indicating severe dementia. Higher scores on the CDR-SOB reflect a worse outcome, as they indicate more severe dementia symptoms.

Time frame

20 Weeks

Secondary outcomes

Change in K-MMSE over 20 weeks

Change in Korean-Mini Mental State Examination (K-MMSE) over 20 weeks

Time frame

20 Weeks

Sponsors and contacts

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

Yonsei University

Lead sponsor

Samjin Pharmaceutical Co., Ltd.

Collaborator

AriBio Co., Ltd.