PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)

NCT06750432 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: PMN310-102
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 22

Brief 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.

Conditions

Alzheimer Disease, Early Onset

Outcome Measures

Primary Outcomes (4)

• Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

  Number and severity of adverse events

  Up to Day 365

• Biomarker response to PMN310 following repeat intravenous infusions of PMN310

  Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310

  Up to Day 365

• Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310

  Percent of patients with symptomatic and/or non symptomatic amyloid-related imaging abnormalities

  Up to Day 365

• Biomarker response to PMN310 following repeat intravenous infusions of PMN310

  Mean change in amyloid PET in response to repeat intravenous infusions of PMN310

  Up to Day 365

Secondary Outcomes (18)

• Pk profile of PMN310 with repeat dosing

  Up to Day 365

• Assessment of the immunogenicity of PMN310 following repeat intravenous infusions

  Up to Day 365

• Assessment of biomarker response to PMN310

  Up to Day 365

• Assessment of cortical and hippocampal volume

  Up to Day 365

• Preliminary efficacy of repeat doses of PMN310 on CDR-SB

  Up to Day 365

Study Arms (3)

Cohort 1 PMN310 350 mg or placebo

EXPERIMENTAL

PMN310 350 mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 2 PMN310 700 mg or placebo

EXPERIMENTAL

PMN310 700 mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Cohort 3 PMN310 1400 mg or placebo

EXPERIMENTAL

PMN310 1400 mg or placebo administered as a 60-minute infusion.

Drug: PMN310; Drug: Placebo

Interventions

PMN310 DRUG

A humanized immunoglobulin G1 (IgG1) monoclonal antibody

Cohort 1 PMN310 350 mg or placebo; Cohort 2 PMN310 700 mg or placebo; Cohort 3 PMN310 1400 mg or placebo

Placebo DRUG

0.9% NaCl 100 mL

Cohort 1 PMN310 350 mg or placebo; Cohort 2 PMN310 700 mg or placebo; Cohort 3 PMN310 1400 mg or placebo

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 1.0 and memory box score ≥ 0.5 at Screening and Baseline
• Objective impairment in episodic memory as indicated by at least 1 standard deviation (SD) below age-adjusted mean in the Wechsler Memory Scale IV-Logical Memory (subscale) II
• MMSE score between ≥ 20 and 28 inclusive at Screening, and
• Either a positive amyloid PET scan within 6 months of Screening consistent with AD, or a positive amyloid PET during Screening.
• Body mass index between 18.5 and 35 kg/m2 inclusive.
• Patients of childbearing potential must meet the following criteria:
• Male and female patients with reproductive potential must be willing to use an approved double barrier contraceptive method (e.g., condom plus intrauterine device, condom plus hormonal contraception, or double barrier device) during and for 120 days after the last dose of study drug
• Females of childbearing potential must have a negative serum pregnancy test during Screening, a negative urine pregnancy test prior to each dose, and not currently be breastfeeding.
• Patients of non-childbearing potential must meet 1 of the following:
• Post-menopausal female (i.e., 12 consecutive months of spontaneous amenorrhea, age \> 51 years, and follicle-stimulating hormone \> 30 mIU/mL)
• Surgically sterile (i.e., bilateral oophorectomy or hysterectomy).

You may not qualify if:

• 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.
• 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:
• History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
• Indication of clinically significant impairment of renal or liver function, including hepatitis B surface antigen, or hepatitis C virus antibody at Screening
• Poorly managed hypertension (systolic \> 160 mmHg and/or diastolic \> 95 mmHg) or hypotension (systolic \< 90 mmHg and/or diastolic \< 60 mmHg). Two repeated assessments during Screening are allowed
• Known uncontrolled diabetes defined by hemoglobin A1c \> 7.5 or insulin dependent diabetes.
• Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose of study drug.
• Seizure in the 3 years prior to Screening.
• History of a clinically significant medical condition that would interfere with the patient's ability to comply with study instructions, would place the patient at increased risk, or might confound the interpretation of the study results.

Sponsors & Collaborators

• ProMis Neurosciences, Inc: lead

Study Sites (22)

Irvine Center for Clinical Research

Irvine, California, 92614, United States

Location

Healthy Brain Research

Long Beach, California, 90804, United States

Location

JEM Research Institute

Atlantis, Florida, 33462, United States

Location

Quantum Laboratories

Deerfield Beach, Florida, 33442, United States

Location

Brain Matters Research

Delray Beach, Florida, 33445, United States

Location

Finlay Medical Research

Miami, Florida, 33126, United States

Location

Gonzalez MD and Aswad MD Health Services, Optimus U Corp

Miami, Florida, 33135, United States

Location

Renstar Medical Research

Ocala, Florida, 34470, United States

Location

Charter Research

Orlando, Florida, 32803, United States

Location

Alzheimer's Research and Treatment Center

Stuart, Florida, 34997, United States

Location

Charter Research

The Villages, Florida, 32162, United States

Location

Alzheimer's Research and Treatment Center

Wellington, Florida, 33414, United States

Location

Conquest Research, LLC

Winter Park, Florida, 32789, United States

Location

Columbus Memory Center, LLC

Columbus, Georgia, 31909, United States

Location

CenExel iResearch, LLC

Decatur, Georgia, 30030, United States

Location

Headlands Eastern MA LLC

Plymouth, Massachusetts, 02360, United States

Location

Advanced Memory Research Institute of NJ

Toms River, New Jersey, 08755, United States

Location

Alzheimer's Disease Research Center

Albany, New York, 12208, United States

Location

Flourish Research

Matthews, North Carolina, 28105, United States

Location

Neuro Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Keystone Clinical Studies, LLC

Plymouth Meeting, Pennsylvania, 19462, United States

Location

Kerwin Medical Center

Dallas, Texas, 75231, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double bind
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: There will be 3 sequential escalating dose cohort groups. Dose groups are 350 mg, 700 mg, and 1400 mg administered as a single 60-minute infusion.

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: December 27, 2024
• Study Start: December 13, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 24, 2025

Record last verified: 2025-12

Locations

US (22)