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Tests treatment safety and results for Lewy Body Dementia
Official title Safety and Efficacy of AR1005 in Patients with Lewy Body Disease
ClinicalTrials.gov ID: NCT06537076
What this study is testing
What is AR1005?
AR1005 is an investigational medicine, being studied as a potential treatment for lewy body dementia.
Also referred to as Scheduled for future release.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 60 and older
You may be able to join if
- 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...
You likely can't join if
- In hematologic and brain magnetic resonance imaging tests conducted within 6 months, other causes of cognitive decline such as neurosyphilis...
- people 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...
- 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 ⑦ If an electroencephalogram...
See the full eligibility criteria
- 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...
- 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 ii. 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 a. 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...
- 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 a. 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 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...
- people 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 ⑦ If an electroencephalogram cannot be performed ⑧ Patients who are already taking acetylcholinesterase...
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 60 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.