PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD) (NCT06750432) | Clinical Trial Compass
Active — Not RecruitingPhase 1
PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)
United States144 participantsStarted 2024-12-13
Plain-language summary
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.
Who can participate
Age range
50 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
. Patient and caregiver provide written informed consent.
. Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator.
. Meets all of the following clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD dementia at Screening:
. National Institute on Aging-Alzheimer's Association criteria for MCI due to AD or mild AD dementia (Stage 3 and 4)
. Global Clinical Dementia Rating (CDR) of 0.5 or 1.0 and memory box score ≥ 0.5 at Screening and Baseline
. MMSE score between ≥ 20 and 30 inclusive at Screening, and
. Either a positive amyloid PET scan within 12 months of Screening consistent with AD, or a positive amyloid PET during Screening.
. Body mass index between 18 and 36 kg/m2 inclusive.
Exclusion criteria
. Living in a continuous care or long-term care nursing facility. Patients in outpatient living at home or in an assisted living facility are eligible for the study.
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.
1Since this is a Phase 1 trial of PMN310, the main goal is to test safety rather than to prove it works — what does that mean for my personal risk compared to what I might gain by joining?
2The trial is no longer actively recruiting new patients, so is it still possible for me to be considered, or should we focus our energy on other options right now?
3PMN310 is given as a repeat intravenous infusion — how often would I need to come in for infusions, and is that kind of schedule realistic given my current health and day-to-day life?
4The trial is tracking biomarker responses, which might include brain imaging like amyloid PET scans — what tests or procedures would I need to go through, and are there any risks associated with those specifically?
5Given that this is early-stage research and standard treatments for early Alzheimer's already exist, do you think it makes more sense for me to try an approved therapy first before considering an experimental Phase 1 study like this one?
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
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Timeframe: Up to Day 337
2
Biomarker response to PMN310 following repeat intravenous infusions of PMN310
Timeframe: Up to Day 337
3
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
. Medical or neurological condition (other than AD; i.e., Parkinson's disease, Huntington's disease, frontal temporal dementia, dementia with Lewy bodies) judged to be contributing to the patient's cognitive impairment.
. Laboratory and electrocardiogram (ECG) abnormalities:
. QT (QTcF) interval \> 450 msec (males) or \> 470 msec (females) during Screening
. Alanine aminotransferase ≥ 2 × upper limit of normal (ULN); aspartate aminotransferase ≥ 2 × ULN; total bilirubin ≥1.5 × ULN during Screening
. Creatinine clearance \< 30mL/min during Screening.
. In the opinion of the Investigator, any clinically significant current or relevant history of physical or psychiatric illness (including suicidal risk, ideation, behavior, or suicide attempts), any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
. Clinically significant recurrent disease or unstable disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments, such as (but not limited to) the following: