Study to assess safety and efficacy of PRI-002 in patients with Mild Cognitive Impairment (MCI) to mild dementia due to Alzheimer's disease
Information about the drug that will be tested in the study
Administration
3 oral capsules in the morning and evening
Is the drug already on the market for another medical condition?
No
Will all participants receive the same drug?
Participants will be selected by chance to receive one of the following options:
- Oral capsules of PRI-002 (low dose)
- Oral capsules of PRI-002 (high dose)
- Oral capsules of placebo (also called a dummy treatment which is an inactive substance identical in appearance to the drug being tested with no active therapeutic effect)
Neither the participant nor his/her doctor will know if the person is receiving the investigational drug or the placebo.
Information about participating in the trial
What are the researchers trying to find out?
The purpose of the study is to evaluate the efficacy and safety of PRI-002 in people with MCI or mild dementia due to Alzheimer's disease.
How long will the treatment last?
- Around 1 year
What your involvement will entail?
- During the study, participants will be asked to complete some laboratory tests (e.g. blood tests) to evaluate the emergent adverse effects (unfavourable signs, symptoms or diseases temporally associated with the use of the drug tested in the study)
- Complete tests that will assess their cognition, function, memory and activities of daily living (i.e. CDR-SB, ADCS-ADL)
- Undergo lumbar puncture (CSF).
Further information on the procedures, tests and number of visits can be obtained from the study team.
Who can participate in this study?
Who can participate in the study?
To take part in the study, participants must:
- Be 50 and 80 years old
- Have a diagnosis of MCI due to AD or mild dementia due to AD, according to the National Institute on Aging and Alzheimer's Association (NIAAA) Research Framework criteria 11
- Have evidence of abnormal accumulation of amyloid in the brain (determined either through CSF examination (lumbar puncture) or with the use of an amyloid PET scan)
- Have a score between 22 and 30 points in the MMSE test (a test about your general thinking skills)
- Have a score of 0.5 or 1 in the Clinical Dementia Rating Global Score (CDR) and CDR Memory Box score of 0.5 or greater
- Have a score ≤85 in the Repeatable battery for the assessment of neuropsychological status - delayed memory index (RBANS-DMI)
- Not being of child-bearing potential, for female participants (be sterilised or postmenopausal)
- Have a body mass index (BMI) between 18.5 and 30.0 kg/m2, inclusive
- Have a study partner who has a sufficient contact with the participant (minimum of 6 hours/week on average), is willing to participate in study procedures throughout the study duration and report on cognitive and functional abilities.
Who cannot participate in the study?
People cannot take part in the study if they have or have experienced:
- Moderate or severe dementia due to Alzheimer’s disease according to National Institute on Aging - Alzheimer's Association (NIA-AA)
- History or evidence of any other central nervous system disorders that could be interpreted as a cause of cognitive impairment or dementia
- History of known or suspected seizures, loss of consciousness, significant head trauma, stroke or transient ischaemic attack within 2 years before screening
- Clinically significant lesions on brain scans
- A disease or condition that may interfere with the safety, tolerability and/or study assessments (e.g., major depression, schizophrenia, vascular disease, stroke, trauma, kidney disease, impaired hepatic function)
- Known to be human immunodeficiency virus (HIV), hepatitis C or chronic hepatitis B positive
- Use of licensed symptomatic Alzheimer’s disease medication for less than 90 days or at a non-stable dose over the past 90 days at Baseline (e.g. acetylcholinesterase inhibitors, memantine, ginkgo)
- Use of anti-Aβ monoclonal antibody therapy at baseline
- Prior or current participation in a clinical trial testing active immunisation against Aβ or tau.
The above list is not exhaustive. It includes the most common conditions and diseases that might exclude people from the study.
Information for your doctor
Clinicaltrials.gov identifier
NCT06182085
EUCT Number
2022-503148-41-00
Study contact information
Link to full text
https://clinicaltrials.gov/study/NCT06182085
https://euclinicaltrials.eu/ctis-public/view/2022-503148-41-00
The information contained in this document is based on information available on public registries (e.g. clinicaltrials.gov website) on September 2024.
This document has been reviewed by a member of the European Dementia Working Group of People with Dementia.
