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Study on the Safety and Effectiveness of PRI-002 for Patients with Mild Cognitive Impairment or Mild Dementia Due to 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 study will test a new treatment called PRI-002, which is a synthetic peptide taken in capsule form. The purpose of the study is to evaluate the safety and effectiveness of PRI-002 in people with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. Participants will receive either the PRI-002 treatment or a placebo, which looks like the treatment but does not contain the active substance.

The study will last for about 48 weeks, during which participants will take the treatment or placebo regularly. Throughout the study, participants will have regular check-ups to monitor their health and any changes in their condition. The study aims to see if PRI-002 can help improve symptoms related to memory and daily functioning in those with Alzheimer’s disease.

Participants will be closely monitored for any side effects or adverse reactions to the treatment. The study will also measure changes in certain markers in the blood and cerebrospinal fluid, which may provide more information about how PRI-002 works in the body. This research is important for understanding new ways to treat Alzheimer’s disease and potentially improve the quality of life for those affected by this condition.

1 joining the study

Upon joining the study, the participant provides written informed consent. This consent is necessary to confirm understanding and agreement to participate in the trial.

Eligibility is confirmed based on criteria such as age, body mass index, and diagnosis of mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes cognitive tests and possibly biomarker analysis through cerebrospinal fluid or imaging techniques.

The participant’s medical history and current health status are reviewed to ensure safety during the trial.

3 medication administration

Participants receive either the study medication, PRI-002, or a placebo. The medication is administered in capsule form and taken orally.

The dosage and frequency are determined by the study protocol, and participants are monitored for any adverse effects.

4 ongoing monitoring

Throughout the trial, participants attend regular visits for monitoring. This includes checking for any side effects and assessing the medication’s impact on cognitive function.

Participants may undergo additional tests to measure changes in biomarkers related to Alzheimer’s disease.

5 final assessment

At the end of the trial period, a final assessment is conducted. This includes repeating cognitive tests and any necessary biomarker analysis.

The results are compared to the initial assessment to evaluate the safety and efficacy of the medication.

6 completion of the study

Upon completion of the study, participants receive information about the overall findings and any next steps, if applicable.

Participants’ health and well-being are ensured before concluding their involvement in the trial.

Who Can Join the Study?

  • The patient must provide a signed and dated written consent, along with a study companion, following the necessary regulations.
  • The patient can be male or female and must be between 55 and 80 years old.
  • If the patient is female, she must not be able to have children.
  • The patient’s Body Mass Index (BMI) should be between 18.5 and 30.0. BMI is a measure that uses height and weight to estimate body fat.
  • The patient must have been diagnosed with MCI (Mild Cognitive Impairment) or mild dementia due to Alzheimer’s disease, following specific criteria.
  • The patient should have a Mini-Mental State Examination (MMSE) score between 22 and 30. This is a test that checks mental functions like memory and attention.
  • The patient should have a Repeatable Battery for the Assessment of Neuropsychological Status – Delayed Memory Index (RBANS-DMI) score of 85 or less. This test measures memory and thinking skills.
  • The patient should have a Clinical Dementia Rating (CDR) global score of 0.5 or 1, with a memory score of at least 0.5. This score helps to assess the severity of dementia.
  • The diagnosis of Alzheimer’s disease must be confirmed by a specific CSF biomarker profile or a positive amyloid PET scan. These are tests that help to confirm the presence of Alzheimer’s disease.

Who Cannot Join the Study?

  • Patients who do not have a diagnosis of Alzheimer’s disease cannot participate. Alzheimer’s disease is a condition that affects memory and thinking skills.
  • Patients who are not experiencing MCI or mild dementia due to Alzheimer’s disease cannot participate. MCI stands for Mild Cognitive Impairment, which is a slight but noticeable decline in memory and thinking skills.
  • Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study organizers.
  • Patients who are not willing or able to follow the study procedures cannot participate.
  • Patients who have other medical conditions that might interfere with the study cannot participate. This is to ensure the safety and accuracy of the study results.
  • Patients who are taking medications that might interfere with the study cannot participate. This is to avoid any interactions that could affect the study outcomes.
  • Patients who have a history of allergic reactions to the study medication cannot participate. This is to prevent any potential allergic reactions during the study.
  • Patients who are pregnant or breastfeeding cannot participate. This is to ensure the safety of both the mother and the baby.
  • Patients who have participated in another clinical trial recently cannot participate. This is to avoid any interference with the current study results.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Rostock University Medical Center Rostock Germany
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Fondazione Policlinico Universitario Agostino Gemelli IRCCS Rome Italy

Other Sites

Site Name City Country Status
Ospedale San Raffaele S.r.l. Milan Italy
Centre Hospitalier Universitaire De Toulouse Toulouse France
Azienda Ospedaliero Universitaria Di Modena Modena Italy
Universitaetsklinikum Aachen AöR Aachen Germany
Hospital Santa Maria Della Misericordia Perugia Italy
Hospital Universitario Dr Peset Aleixandre Valencia Spain
Centre Hospitalier Universitaire De Nice Nice France
Clintrial s.r.o. Prague Czechia
Università degli studi Gabriele D’Annunzio Chieti-Pescara Centro di Studi e tecnologie avanzate Chieti Italy
Neuro Health Centrum s.r.o. Brno Czechia
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Fondazione Salvatore Maugeri Clinica Del Lavoro E Della Riabilitazione Pavia Italy
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universita Degli Studi Di Brescia Brescia Italy
Fundacio Ace Institut Catala De Neurociencies Aplicades Barcelona Spain
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
Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit Mannheim Germany
Euromedis Sp. z o.o. Szczecin Poland
Revit Sp. z o.o. Bialystok Poland
Krakowska Akademia Neurologii Sp. z o.o. Cracow Poland
NeuropsychiatrieHK s.r.o. Prazske Predmesti Czechia
Neuroprotect Sp. z o.o. Warsaw Poland
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Neuropsychiatrie s.r.o. Prague Czechia
Brain Research Center Den Bosch B.V. s-Hertogenbosch The Netherlands
Wielospecjalistyczne Centrum Medyczne IBISMED S.C Zabrze Poland
Hospices Civils de Lyon (HCL) – Hôpital des Charpennes Villeurbanne France
A-Shine s.r.o. Plzen Czechia
Forbeli s.r.o. Prague Czechia
Oroitu S.L. Algorta Spain
Afptlnp Ukrgb Szadsyzvy Leougq Dx Bupcagc Bologna Italy
Nihgvfzj Bmzefmqrmcczu Tddbqrgzhkm Lnqtjur sehqh Cracow Poland
Uoimunliqseyewuftxqqm Mhjwtmqp Aaz Munster Germany
Utvytmzjjt Dsmwm Septp Dj Rlzq Lw Spcjrzor Rome Italy
Uuujmnqokabpfzrjiblqc Dxlkvnfyngo Aav Duesseldorf 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
31.10.2023
France France
Not yet recruiting
31.10.2023
Germany Germany
Not recruiting
31.10.2023
Italy Italy
Not recruiting
31.10.2023
Poland Poland
Not recruiting
31.10.2023
Spain Spain
Not recruiting
31.10.2023
The Netherlands The Netherlands
Not recruiting
31.10.2023

Trial locations

PRI-002 is a medication being studied for its safety and effectiveness in patients with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease. The trial aims to determine how well patients tolerate the medication and to observe any side effects that may occur. Additionally, the study evaluates how effective PRI-002 is in improving symptoms of dementia, using a specific scale to measure changes in the patients’ condition.

Investigated diseases:

Alzheimer’s disease – Alzheimer’s disease is a progressive neurological disorder that leads to memory loss and cognitive decline. It primarily affects older adults and is characterized by the gradual deterioration of brain cells. As the disease progresses, individuals may experience confusion, difficulty with language, and impaired reasoning. In the later stages, it can lead to significant memory loss and the inability to perform daily tasks. The exact cause is not fully understood, but it involves the accumulation of proteins in the brain. Over time, Alzheimer’s disease can severely impact a person’s ability to function independently.

Trial ID:
2022-503148-41-00
Protocol code:
PRI-002-04
Trial Phase:
Therapeutic exploratory (Phase II)

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