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

3 1

What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Hopital Beaujon Clichy France
Hospital Del Mar Barcelona Spain
Amphia Hospital Breda The Netherlands
A-Shine s.r.o. Plzen Czechia
Sanos A/S Gandrup Denmark
Universitätsklinikum des Saarlandes – Homburg/Saar, Klinik für Urologie und Kinderurologie Homburg Germany
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Brain Research Center Zwolle B.V. Zwolle The Netherlands
NZOZ Wroclawskie Centrum Alzheimerowskie Wroclaw Poland
Hwfxhlra Vhyn dyulbjoz Barcelona Spain
Vvrjoy djj Rtcsq Uzvhjrrcfg Hvnbqigf Sevilla Spain
Oswbri Uzbmsqsade Hydhreux Odense Denmark
Akhj Gdymwo Oefoxmso Mkdnymoruuxrm Nbygyqew Milan Italy
Ammullbjfp Pwukztlw Hrvrqhoz Dp Mqoxoiayk Marseille France
Crllouv Uvarwarxirxqqjvlwqvz Bwsqbq Kcs Berlin Germany
Utylchqwczexhjjrk Pgbpkeovbbn Dypfq Mfmqtu Ancona Italy
Axmgiaa Opuexqznaqd Uzsmhaaqpiigs Cllsbtuvpyas Dmlba Sxixdv E Dkrsn Sltmgco Dl Tqknlx Turin Italy
Unqztpjbevqzmfdzxkxgn Mcbdnkxj Alf Munster Germany
Cpjtgx Humfanhcvsg Uqofhmxqcqtny Dg Rpqxee Rennes France
Uvipliuujj Depah Ssxvp Dt Rgjz Lg Soupvcob Rome Italy
Uqgitqmpkdbqvasdshliu Awltnb Ajo Aachen Germany
Cqkxnf Hyoopzbicez Lwzk San Pierre Benite France
Hnxuxoau Utwxcsufsslla 1x Dk Oxxrihl Madrid Spain
Fgbwnagwxh Ixaia Sqp Grrrtgg Ddt Tmpewsa Monza Italy
Hbgmxuty Upiihzpqciuyba Sipwtntmrl &uwohnf Hwartxn dd Hfbogxfvnfc STRASBOURG, Alsace France
Ajitawq Ocxwtcuegbf Ubefxbcronbma Ppnfxo Pisa Italy
Kkxjst Mm Sbx z oqta Bialystok Poland
Ewz Nrbluyzqwwtb Szj z oreg Warsaw Poland
Pcl Fyqeecuthh Dd Cybae E Rzlvicyvi Cgdk G Phgvrf Tricase Italy
Bftwi Rynksfmz Cowtgf Dpi Bujai Byba S-Hertogenbosch The Netherlands
Nleuhkloupdbzpgi ssppsz Prague Czechia
Ohkxbda Btalumpm Nhihjsn Dcuizgoimbo Cdpgku Oiufnlcyjrf Ipt Kwdgrvo Hwcueiw Ktvdzaqhs Gjayhnnojxiq Owirbms Aibyxbrobimeif Ssw z oqrh Scinawa Poland
Pnikcrdzv Cbaqxjx Pquxfotnplbpwfi Bialystok Poland
Ujhrumnnnlisipvurvpkm Uyc Guenzburg Germany
Fxmwxlgbab Grrt Offenbach Am Main Germany
Nkwgrgmgsy Sme z oxar smfon Katowice Poland
Fbnfbzt sqkduq Prague Czechia
Fiitnemf Nhsqvcike U So Avwl V Bcsw Brno-Stred Czechia
Vwuauk Clquugr sksnpo Rychnov Nad Kneznou Czechia
Oelsedqj Fxoltzwpqjnilikb Ienuu Tliaxwkk Gowxgsy Iuosr Rome Italy
Pkktchyic Llbnggqm Vbztjk Dbiyjdqojqy Omvjhgjqniv Dz Sbh Goidcpgh Dg Dfl Fygdhpisddshyfap Brescia Italy
Ufqjuvjiwe Hfazdxcll Pgycp Sunyvlolupo Cgtsaue Fere Paris France
Pzsemtygkbg Gmbqgvhz Svpi Donostia / San Sebastian Spain
Iixe mlyzyel sboqau Prague Czechia
Bzwcj Rhzcxbkc Chlvrk Ainxzkjkb Bemc Amsterdam The Netherlands
Nnvhsng svtdja Chocen Czechia
Buaqmhmozpsjdxceh sqsitm Kladno Czechia
Dnhizwctq Gmnd Ipfsdmnn fgsr Shreiou zux Pjkhumaxift Glhcssdxle Mannheim Germany
Zommwma fluf kcmnhulem Fovacgdgt Dxb Iq Sjxtmib Gwob Bad Homburg Germany

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Czechia Czechia
Not recruiting
26.04.2024
Denmark Denmark
Not recruiting
26.04.2024
France France
Not recruiting
26.04.2024
Germany Germany
Not recruiting
26.04.2024
Italy Italy
Not recruiting
26.04.2024
Poland Poland
Not recruiting
26.04.2024
Spain Spain
Not recruiting
26.04.2024
The Netherlands The Netherlands
Not recruiting
26.04.2024

Trial locations

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.

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 ID:
2023-508306-15-00
Protocol code:
AR1001-ADP3-US01
NCT ID:
NCT05531526
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • Using [18F]DED PET imaging to study brain changes in patients with Alzheimer’s disease, CADASIL, and other forms of dementia.

    Recruiting

    2 1 1
    Investigated Drugs:
    Spain
  • Study of flortaucipir and florbetapir in patients with memory disorders including Alzheimer’s disease and dementia

    Recruiting

    4 1 1 1
    Investigated Diseases:
    France