Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzhe… (NCT06182085) | Clinical Trial Compass
Active — Not RecruitingPhase 2
Study to Assess Safety and Efficacy of PRI-002 in Patients With MCI to Mild Dementia Due to Alzheimer's Disease (AD)
Czechia304 participantsStarted 2023-12-01
Plain-language summary
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 range55 Years – 80 Years
SexALL
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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.
✓. 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
✕
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).
. 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).