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

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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
Etg Neuroscience Sp. z o.o. Warsaw Poland
Sanos A/S Gandrup Denmark
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Universitario 12 De Octubre Madrid Spain
Hospital Del Mar Barcelona Spain
Amphia Hospital Breda The Netherlands
FutureMeds GmbH Berlin Germany
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
Policlinica Gipuzkoa S.A. Donostia / San Sebastian Spain
Fondazione IRCCS San Gerardo Dei Tintori Monza Italy
INEP medical s.r.o. Prague Czechia
Brain Research Center Amsterdam B.V. Amsterdam The Netherlands
Brain Research Center Zwolle B.V. Zwolle The Netherlands
Neurohk s.r.o. Chocen Czechia
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit Mannheim Germany
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
Odense University Hospital Odense Denmark
Klimed MK Sp. z o.o. Bialystok Poland
Pia Fondazione Di Culto E Religione Card G Panico Tricase Italy
A-Shine s.r.o. Plzen Czechia
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Virgen del Rocío University Hospital Sevilla Spain
Ospedale San Raffaele S.r.l. Milan Italy
ASST Grande Ospedale Metropolitano Niguarda Milan Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Saarland University Hospital Homburg Germany
Universita’ Di Pisa Pisa Italy
Universita’ Politecnica Delle Marche Ancona Italy
Fakultni Nemocnice U Sv Anny V Brne Brno-Stred Czechia
Centre Hospitalier Universitaire De Nantes Nantes France
Vestra Clinics s.r.o. Rychnov Nad Kneznou Czechia
Centre Hospitalier Universitaire De Rennes Rennes France
Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola Rome Italy
Provincia Lombardo Veneta Dell’ordine Ospedaliero Di San Giovanni Di Dio Fatebenefratelli Brescia Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Neuropsychiatrie s.r.o. Prague Czechia
Forbeli s.r.o. Prague Czechia
NZOZ Wrocławskie Centrum Alzheimerowskie Wroclaw Poland
Ujwuqdpqfw Hmgnjcsps Pltld Siycztsawmo Cpvawkn Fdmi Paris France
Ottiixz Bviouzji Nuadeni Dzixzypzgjr Cnpyby Oujzxtqvbri Ieq Kxbexbc Hjmgzqt Kuoogechf Gsxnhmnophlq Opkwfaz Aorfborutysakd Seo z oztd Scinawa Poland
Ppapxkjdl Cmhqdmo Phlsiheblhsvbrb Bialystok Poland
Uiznobwdztlpexgvfjgvq Uqh Guenzburg Germany
Nwjatboldy Shv z ovuy sagyh Katowice Poland
Behfnyhafzjzpxdcp songnm Kladno Czechia
Amqfyyjork Pyjkqsga Hatpfjux Dv Mcscdduku Marseille France
Agsrsid Oxpiizockwa Ucbqjnbxqhlew Czqzrdyzuhdh Dxdpe Sssbgp E Dypko Sprldvc Di Tcrefi Turin Italy
Ukmqncuhnqzwexucucvhk Mvmmuibt Adu Munster Germany
Ucndaqicfn Dtptp Swwpb Dl Ruea Lw Sodujdkn Rome Italy
Hwnsxpeh Vtim dstxjhlu Barcelona Spain
Havumobs Udghgqqoqltimc Sxdfvvhiqt &sajvff Hpyjmqi dm Hzvshgqjrdp STRASBOURG, Alsace France

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.

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)

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