2022-503148-41-00CompletedPhase 2
Randomised, double-blind, placebo-controlled study to assess safety and efficacy of PRI-002 in patients with MCI or mild dementia due to Alzheimer’s disease (AD)
Source: EU CTIS (euclinicaltrials.eu) · Last updated 18 Jun 2026
Brief summary (registry, in English)
Safety To evaluate the safety and tolerability of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on incidence of drug-related adverse events (AEs). Efficacy To evaluate the efficacy of multiple doses of PRI-002 in subjects with MCI or mild dementia due to AD, based on the Clinical Dementia Rating-Sum of Boxes (CDR-SB).
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 339 (actual)
- First submitted
- 3 Jul 2023
- Start date
- 1 Dec 2023
- Lead sponsor
- Prinnovation GmbH
- Diseases
- Alzheimer disease
- EU CT number
- 2022-503148-41-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 339
- 45 sites in 7 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Other illness
- History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia
Who the study is looking for
- Signed and dated written informed consent obtained from the subject and study companion in accordance with applicable regulations
- Male or female, aged 55 to 80 years, inclusive
- For female subjects: not being of child-bearing potential
- Body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
- Diagnosed with MCI due to AD or mild dementia due to AD, according to the National Institute on Aging and Alzheimer’s Association (NIA‐AA) criteria
- MMSE score of 22 to 30, inclusive
- Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI) score ≤85
- CDR global score of 0.5 or 1 with a memory score ≥0.5
- Confirmation of AD diagnosis, by CSF biomarker profile reflecting AD, according to NIA-AA, or existing positive amyloid positron emission tomography (PET) evidence
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (45)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Neuro Health Centrum s.r.o. | Brno-Líšeň | Czechia | Completed |
| A-Shine s.r.o. | Plzen 3 | Czechia | Completed |
| INEP medical s.r.o. | Prague | Czechia | Completed |
| FORBELI s.r.o. | Prague | Czechia | Completed |
| Clintrial s.r.o. | Prague 10 | Czechia | Completed |
| Neuropsychiatrie s.r.o. | Prague 6 | Czechia | Completed |
| NeuropsychiatrieHK s.r.o. | Prazske Predmesti | Czechia | Completed |
| Universitaetsklinikum Aachen AöR | Aachen | Germany | Completed |
| Charite Universitaetsmedizin Berlin KöR | Berlin | Germany | Completed |
| Universitaetsklinikum Duesseldorf AöR | Duesseldorf | Germany | Completed |
| Universitaetsklinikum Magdeburg AöR | Magdeburg | Germany | Completed |
| Dynamikos GmbH Institut fuer Studien zur Psychischen Gesundheit | Mannheim | Germany | Completed |
| Universitaetsklinikum Muenster AöR | Muenster | Germany | Completed |
| Klinikum rechts der Isar der TU Muenchen AöR | Munich | Germany | Completed |
| Rostock University Medical Center | Rostock | Germany | Completed |
| Universitaetsklinikum Ulm AoR | Ulm | Germany | Completed |
| Fundació ACE, Institut Català de Neurociències Aplicades | Barcelona | Spain | Completed |
| Oroitu S.L. | Getxo | Spain | Completed |
| University Clinical Hospital Virgen De La Arrixaca | Murcia | Spain | Completed |
| Hospital Universitario Virgen De La Macarena | Sevilla | Spain | Completed |
| Hospital Universitario Dr. Peset Aleixandre | Valencia | Spain | Completed |
| Clinica Montecanal S.L. | Zaragoza | Spain | Completed |
| Centre hospitalier Universitaire de Bordeaux | Bordeaux | France | Withdrawn |
| Centre Hospitalier Universitaire de Nice | Nice | France | Withdrawn |
| Centre Hospitalier Universitaire de Toulouse | Toulouse | France | Withdrawn |
| Hospices Civils De Lyon | Villeurbanne | France | Withdrawn |
| Azienda Unita Sanitaria Locale Di Bologna | Bologna | Italy | Completed |
| Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia | Brescia | Italy | Completed |
| Universita' Degli Studi G. D'annunzio Di Chieti | Chieti | Italy | Completed |
| Ospedale San Raffaele S.r.l. | Milan | Italy | Completed |
| Istituti Clinici Scientifici Maugeri S.p.A. Societa' Benefit In Forma Abbreviata Istituti Clinici Scientifici Maugeri S.p.A. Sb O Anche Ics Maugeri S.p.A. Sb O Maugeri S.p.A. Sb | Milan | Italy | Completed |
| IRCCS Foundation Istituto Neurologico Carlo Besta | Milan | Italy | Completed |
| Azienda Ospedaliero - Universitaria di Modena | Modena | Italy | Completed |
| Hospital Santa Maria Della Misericordia | Perugia | Italy | Completed |
| Azienda Ospealiero Universitaria Policlinico Umberto I | Rome | Italy | Completed |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS | Rome | Italy | Completed |
| Brain Research Center Amsterdam B.V. | Amsterdam | Netherlands | Completed |
| Brain Research Center Den Bosch B.V. | 's-Hertogenbosch | Netherlands | Completed |
| Brain Research Center Zwolle B.V. | Zwolle | Netherlands | Completed |
| Revit Sp. z o.o. | Bialystok | Poland | Completed |
| Krakowska Akademia Neurologii Sp. z o.o. | Cracow | Poland | Completed |
| Neurocor Banaszkiewicz Tomaszewski Lekarze sp.p. | Cracow | Poland | Completed |
| EUROMEDIS Sp z o o | Szczecin | Poland | Completed |
| Centrum Medyczne NeuroProtect | Warsaw | Poland | Completed |
| IBISMED Wielospecjalistyczne Centrum Medyczne | Zabrze | Poland | Completed |
This page is information, not medical advice. Discuss any trial with your doctor.