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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)
EU CTIS ID: 2022-503148-41-00
What this study is testing
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).
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
You likely can't join if
- History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia
See the full eligibility criteria
- 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
- History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.