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)
Key facts
- Where
- Bologna, Brescia, Chieti, Milan, Modena, Perugia és Rome, OlaszországSee the 10 sites
- Phase
- 2. fázis
Where in Olaszország
- Azienda Unita Sanitaria Locale Di BolognaBologna, OlaszországNo longer taking part
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di BresciaBrescia, OlaszországNo longer taking part
- Universita' Degli Studi G. D'annunzio Di ChietiChieti, OlaszországNo longer taking part
- IRCCS Foundation Istituto Neurologico Carlo BestaMilan, OlaszországNo longer taking part
- 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. SbMilan, OlaszországNo longer taking part
- Ospedale San Raffaele S.r.l.Milan, OlaszországNo longer taking part
- Azienda Ospedaliero - Universitaria di ModenaModena, OlaszországNo longer taking part
- Hospital Santa Maria Della MisericordiaPerugia, OlaszországNo longer taking part
- Azienda Ospealiero Universitaria Policlinico Umberto IRome, OlaszországNo longer taking part
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Prinnovation GmbH
- Trial code
- EU 2022-503148-41-00
- Record updated
- 2026. június 18.
- Original description
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).Read full original descriptionShow less
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).
Inclusion: 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.
Exclusion: History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia.