Alzheimer's disease (AD) is the most common form of dementia. In the brains of people with AD, certain small substances stick together. This leads to changes in thinking and behaviour. The company PRInnovation is developing a new treatment for Alzheimer's disease, called PRI-002. It is thought that PRI-002 can cut the sticked substances back into small pieces. That would reduce the effects of Alzheimer's disease. In the current study the investigators examine whether PRI-002 is safe and effective in participants with mild cognitive impairment (MCI) or mild dementia due to AD.
Who can participate
Age range
55 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion 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. This is defined as either permanently sterilised (via hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or postmenopausal (defined as no menses for 12 months without an alternative medical cause).
. 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 NIA-AA criteria.
. MMSE score of 22 to 30, inclusive.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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).
Timeframe: Baseline to week 48.
2
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).
. 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.
Exclusion criteria
. Unable to give informed consent in accordance with applicable regulations.
. Diagnosed with moderate or severe dementia due to AD according to NIA-AA.
. History or evidence of any other central nervous system (CNS) disorder(s) that could be interpreted as a cause of cognitive impairment or dementia.
. History of known or suspected seizures, loss of consciousness, or significant head trauma within 2 years before Screening.
. History of known or suspected stroke or transient ischaemic attack (TIA) within 2 years before Screening.
. Evidence of other clinically significant lesions on brain MRI (Fazekas score 3).
. History or presence of clinically evident cerebrovascular disease (diagnosis of possible, probable, or definite vascular dementia).
. Other significant pathological findings on brain MRI (for example more than 10 microhaemorrhages or a single macrohaemorrhage \>10 mm at the greatest diameter).