Lewy Body DementiaPhase 2AR1005NCT06537076
Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
A Phase 2 study testing AR1005 and Rivastigmine 3 mg in people with Lewy Body Dementia, run by Yonsei University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Lewy Body Dementia
- What is being tested?
- AR1005 and Rivastigmine 3 mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jan 2024to Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Medical history, neurological examination, hematologic examination, Seoul neuropsychological examination 2nd edition, brain magnetic resonance imaging suspected of cognitive impairment due to dementia with Lewy bodies as the cause of cognitive decline
- Lewy body dementia
Show all 37Show fewer
- In accordance with the guidelines for the 4th report of the Dementia with Lewy Bodies Consortium (DLBC) published in 2017, if it falls under Probable Dementia with Lewy Bodies
- Required Requirements
- Dementia, defined as cognitive decline that progresses sufficiently to impair normal social and professional functions or daily life
- Defects in attention, enforcement, and space-time capabilities are noticeable in the inspection
- Core clinical features
- variation in cognitive function
- vision
- Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness
- REM sleep behavior disorder
- Indicative biomarker
- Decreased intake of dopamine carrier PET-phase nuclear
- [I-123]-MIBG myocardial scintigraphy intake decreased
- REM sleep behavior disorder according to polymorphic test
- In the case of two or more key aspects, or one or more key clinical features and one or more indicative biomarkers are satisfied
- Bulb Lewy body dementia (Prodromal DLB)
- <!-- -->
- If it falls under the Probable MCI-LB with a mild cognitive impairment according to the criteria for diagnosing precursor Lewy body dementia announced in 2020
- Required Requirements
- cognitive decline observed when judged by the patient, guardian, or clinician b. Objective cognitive decline (although it is not related to any cognitive domain, it should be mainly related to the deterioration of execution function and space-time ability)
- Core clinical features
- variation in cognitive function
- vision (nap, dazed, same document, angry)
- Parkinson's syndrome: One or more manifestations of sinusitis, stable progress, or stiffness
- REM sleep behavior disorder
- Indicative biomarker
- Decreased intake of dopamine carrier PET-phase nuclear b. [I-123]-MIBG myocardial scintigraphy intake decreased c. REM sleep behavior disorder according to polymorphic test
- The leading mild cognitive impairment due to dementia with Lewy bodies has two or more key features or satisfies one or more key clinical features and one or more indicative biomarkers
- ⑥ Patients with caregivers who are in regular contact with the subject (Note: caregivers may support the subject during the clinical trial [compliance supervision and reporting of the subject's status], defined as those who spend at least 8 hours per week with the subject)
- ⑦ Patients who can walk or move with walking aids (i.e., walkers, canes, or wheelchairs)
- ⑧ Patients with sufficient vision, hearing, language skills, motor skills, and comprehension to follow the examination procedure as judged by the tester (Aids such as glasses and hearing aids are allowed)
- ⑨ an examination Patients who have voluntarily decided to participate in this clinical trial and obtained the consent of the subject in writing from both the subject and the subject's legal representative (where written consent is not available, the tester shall keep a record of the matters that the subject has verbally agreed to participate in the trial)
Who cannot join
- 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)
- voluntary Employees directly involved in this clinical study or their immediate family members who find it difficult to participate
- If there is a history of psychiatric disorders: major effective disorder, schizophrenia, schizo-effective disorder
Show all 11Show fewer
- ⑦ If an electroencephalogram cannot be performed
- ⑧ Patients who are already taking acetylcholinesterase inhibitor (donepezil and rivastigmine) or taking it in patch form (but can change to rivastigmine PO to participate in the study)
- ⑨ Patients with moderate to severe liver disorder (Child-Pugh grade B) and dialysis due to decreased renal functiona patient with end-stage renal impairment receiving
- ⑩ Patients discontinued administration due to aseptic meningitis associated with AR1005-KRP2-01
- ⑪ Patients with genetic problems such as galactose intolerance, lactose-degrading enzyme deficiency, or glucose-galactose absorption disorders
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Severance Hospital
Seoul, 03722
Jung Lim Lee
About this study
Official title: A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
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.
Read the detailed description
60 patients will be randomized into either active or placebo groups (1:1). Both groups will concurrently receive standard treatment with rivastigmine for 20 weeks.
- Conditions
- Lewy Body Dementia
- Being tested
- AR1005, Placebo, Rivastigmine 3 mg
- Keywords
- Lewy body dementia, DLB
- Medical subject headings
- Lewy Body Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AR1005Drug
Also called Scheduled for future release
AR1005 inhibits sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate.
PlaceboDrug
Matching placebo for AR1005 to be administered BID for 20 weeks
Rivastigmine 3 mgDrug
3mg Rivastigmine will be administered BID for both active and placebo groups
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | AR1005 50 mg BID will be administered with rivastigmine 3 mg BID for 20 weeks. Receives: Drug: AR1005; Drug: Rivastigmine 3 mg |
| Placebo | Placebo comparator | Placebo BID will be administered with rivastigmine 3 mg BID for 20 weeks. Receives: Drug: Placebo; Drug: Rivastigmine 3 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 20 Weeks
Secondary outcomes (1)
Change in K-MMSE over 20 weeks
Change in Korean-Mini Mental State Examination (K-MMSE) over 20 weeks
Measured: 20 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jan 2024
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lewy Body DementiaStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd., AriBio Co., Ltd.
- Responsible party
- Principal investigator, Byoung Seok Ye, Yonsei University
- Investigators
- Byoung Seok Ye, MD, PhD, Principal investigator, Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06537076
- Sponsor's protocol ID
- AR1005-KRP2-01
- Acronym
- AR1005
- Status last verified
- Sep 2024
- First submitted
- 31 Jul 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Phase IIa Clinical Trial to Study the Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
- ClinicalTrials.gov ID
- NCT06537076
- Acronym / sponsor ID
- AR1005 / AR1005-KRP2-01
- Conditions
- Lewy Body Dementia
- Keywords
- Lewy body dementia, DLB
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Collaborators
- Samjin Pharmaceutical Co., Ltd., AriBio Co., Ltd.
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 5 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
60 patients will be randomized into either active or placebo groups (1:1). Both groups will concurrently receive standard treatment with rivastigmine for 20 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Drug: AR1005, Drug: Rivastigmine 3 mgAR1005 50 mg BID will be administered with rivastigmine 3 mg BID for 20 weeks. |
| Placebo | Placebo comparator | Drug: Placebo, Drug: Rivastigmine 3 mgPlacebo BID will be administered with rivastigmine 3 mg BID for 20 weeks. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (37 listed)
- men and women over the age of 60
- <!-- -->
- ⑥ Patients with caregivers who are in regular contact with the subject (Note: caregivers may support the subject during the clinical trial [compliance supervision and reporting of the subject's status], defined as those who spend at least 8 hours per week with the subject)
- ⑦ Patients who can walk or move with walking aids (i.e., walkers, canes, or wheelchairs)
- ⑧ Patients with sufficient vision, hearing, language skills, motor skills, and comprehension to follow the examination procedure as judged by the tester (Aids such as glasses and hearing aids are allowed)
Key exclusion criteria (11 listed)
- 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
- ⑦ If an electroencephalogram cannot be performed
- ⑧ Patients who are already taking acetylcholinesterase inhibitor (donepezil and rivastigmine) or taking it in patch form (but can change to rivastigmine PO to participate in the study)
- ⑨ Patients with moderate to severe liver disorder (Child-Pugh grade B) and dialysis due to decreased renal functiona patient with end-stage renal impairment receiving
- ⑩ Patients discontinued administration due to aseptic meningitis associated with AR1005-KRP2-01
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AR1005Also: Scheduled for future releaseAR1005 inhibits sodium currents by selective binding to the inactive sodium channel, suppressing the release of the excitatory amino acid, glutamate. | Drug | Experimental |
| PlaceboMatching placebo for AR1005 to be administered BID for 20 weeks | Drug | Placebo |
| Rivastigmine 3 mg3mg Rivastigmine will be administered BID for both active and placebo groups | Drug | Experimental, Placebo |
Primary outcome
Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20
Time frame: 20 Weeks
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.
1 secondary outcome
Change in K-MMSE over 20 weeks
Time frame: 20 Weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Individual participant dataSharing planned: Yes
Related trials for Lewy Body Dementia
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Recruiting
Transcranial Alternating Current Stimulation in Lewy Body Dementia
Lewy Body Dementia (LBD), Transcranial Alternating Current Stimulation
RecruitingPhase 2
A Study of Donanemab (LY3002813) in Participants With Early Cognitive Decline (TRAILBLAZER-ALZ 7)
Cognitive Dysfunction, Lewy Body Disease
RecruitingPhase 2
Phase 2, Efficacy and Safety Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
RecruitingPhase 3
Phase 3, Open Label Extension Study of ACP-204 in Lewy Body Dementia Psychosis
Lewy Body Dementia Psychosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byoung Seok Ye, MD, PhD principal investigator
Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AR1005 and Rivastigmine 3 mg in people with Lewy Body Dementia, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 37 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung Lim Lee (+82-2-2227-7716, jll2024@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Dementia Rating-Sum Of Boxes (CDR-SOB) at Week 20 (time frame: 20 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.