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Study on the Effects of AR1001 (Mirodenafil Dihydrochloride) for Patients with Early Alzheimer's Disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's Disease, a condition that affects memory and thinking skills. The trial will evaluate a treatment called AR1001, which is a film-coated tablet containing the active substance mirodenafil dihydrochloride. The study will compare the effects of AR1001 with a placebo tablet to understand its effectiveness and safety in people with early stages of Alzheimer's Disease.

The purpose of the study is to assess how well AR1001 works over a period of 52 weeks. Participants will be randomly assigned to receive either the AR1001 tablet or a placebo tablet. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not influenced by expectations about the treatment.

Throughout the study, participants will take the tablets orally and will be monitored regularly to track changes in their condition. The main focus will be on changes in their cognitive abilities, daily living activities, and mood over the course of the year. The study aims to provide valuable information about the potential benefits of AR1001 for individuals with early Alzheimer's Disease.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes evaluating cognitive function and memory decline, as well as confirming a positive biomarker for brain amyloid pathology.

    Participants must have a Mini-Mental Status Examination (MMSE) score of 20 or higher and a Clinical Dementia Rating (CDR) global rating of 0.5 or 1.

  2. Step 2

    Randomization

    Participants are randomly assigned to receive either the study medication, AR1001, or a placebo. This process is double-blind, meaning neither the participants nor the researchers know who receives the actual medication.

  3. Step 3

    Medication administration

    Participants take the assigned medication orally in the form of a film-coated tablet. The medication is administered daily for a duration of 52 weeks.

  4. Step 4

    Regular monitoring

    Throughout the 52-week period, participants undergo regular monitoring to assess the efficacy and safety of the treatment. This includes evaluations using the Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB) and other cognitive and functional assessments.

    Changes in the Alzheimer’s Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog 13), the Amsterdam-Instrumental Activities of Daily Living Questionnaire-Short Version (A-IADL-Q-SV), and the Geriatric Depression Scale-15 (GDS-15) are also monitored.

  5. Step 5

    Final assessment

    At the end of the 52-week period, a final assessment is conducted to evaluate changes in cognitive and functional abilities compared to the baseline measurements.

Who can join the trial?

10 criteria

  • Participants must be men or women aged between 55 and 85 years old at the time they sign the consent form.
  • Participants need to have a study partner, like a family member or friend, who sees them at least 5 days a week and can provide information about their memory, behavior, and safety. This person must be able to attend clinic visits and be available for the entire study.
  • Participants should have mild memory problems or mild dementia related to Alzheimer's, as defined by specific stages from a recognized association.
  • Participants must have experienced memory decline starting within the last 5 years, confirmed by their study partner.
  • Participants need to have a score of 20 or higher on a test called the **MMSE**, which checks mental abilities.
  • Participants should have a **CDR** global rating of 0.5 or 1, which measures the severity of dementia.
  • Participants must have a score of 85 or lower on a specific memory test called the **RBANS**.
  • If there is a past **MRI** scan available, it should show no other reasons for dementia.
  • Participants must have a positive test result for **brain amyloid**, a protein linked to Alzheimer's, confirmed by specific tests.
  • Participants and their caregivers must be able to sign a consent form to join the study, and participants should be able to understand and agree to participate.

Who cannot join the trial?

10 criteria

  • Participants with any other serious medical condition that could interfere with the study.
  • Individuals who have had a recent major surgery or are planning to have surgery during the study period.
  • People who are currently participating in another clinical trial.
  • Individuals with a history of drug or alcohol abuse.
  • Participants who are unable to comply with the study procedures.
  • Women who are pregnant or breastfeeding.
  • Individuals with a known allergy to the study medication or its ingredients.
  • People with severe liver or kidney disease.
  • Participants with uncontrolled high blood pressure.
  • Individuals with a history of certain mental health disorders.
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Investigated drugs

AR1001 is a medication being studied for its potential to help people with early Alzheimer's disease. The trial aims to see how effective and safe AR1001 is over a period of 52 weeks. Participants in the study will receive AR1001 to determine if it can improve symptoms or slow the progression of Alzheimer's disease.

What is already known about the treatment

AR1001 – AR1001 is administered orally in the form of tablets. It is currently being studied in clinical trials for its potential use in treating early Alzheimer's disease. The main therapeutic indication for AR1001 is Alzheimer's disease, specifically in its early stages. At the molecular level, AR1001 is believed to work by enhancing neuronal function and reducing neuroinflammation, which may help slow the progression of Alzheimer's disease. It is classified pharmacologically as a neuroprotective agent.

Investigated diseases

Alzheimer's Disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease advances, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. Eventually, it can impair the ability to carry out daily activities and recognize familiar people. The progression of Alzheimer's disease varies among individuals, but it generally leads to significant impairment in cognitive and functional abilities.
Trial detailsLast updated 4 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508306-15-00Protocol codeAR1001-ADP3-US01Estimated enrolment1 477 patientsSponsorAribio Co. Ltd.

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