PRECISE-AD Clinical Trial

Trial Summary

Official Title

A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients With Early Alzheimer's Disease

Status

Recruiting

Condition

Alzheimer's Disease, Early Alzheimer's Disease

Actual Start Date

December 2024

Additional Information

Clinicaltrials.gov ID: NCT06750432

About The Trial

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

This study is a Phase 1b, randomized, double-blind, placebo-controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (5 mg/kg, 10mg/kg, and 20 mg/kg are planned). Patients will be randomly assigned 3:1, PMN310: placebo.

Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.

Locations

The following cities have PRECISE-AD clinical trial sites. Please check back often as locations will be updated.

  • Irvine Center for Clinical Research
    Irvine, California, United States, 92614
  • Healthy Brain Research
    Long Beach, California, United States, 90804
  • JEM Research Institute
    Atlantis, Florida, United States, 33462
  • Quantum Laboratories
    Deerfield Beach, Florida, United States, 33442
  • Brain Matters Research
    Delray Beach, Florida, United States, 33445
  • Finlay Medical Research
    Miami, Florida, United States, 33126
  • Gonzalez MD and Aswad MD Health Services, Optimus U Corp
    Miami, Florida, United States, 33135
  • Renstar Medical Research
    Ocala, Florida, United States, 34470
  • Charter Research
    Orlando, Florida, United States, 32803
  • Alzheimer's Research and Treatment Center
    Stuart, Florida, United States, 34997
  • Charter Research
    The Villages, Florida, United States, 32162
  • Alzheimer's Research and Treatment Center
    Wellington, Florida, United States, 33414
  • Conquest Research, LLC
    Winter Park, Florida, United States, 32789
  • Columbus Memory Center, LLC
    Columbus, Georgia, United States, 31909
  • CenExel iResearch, LLC
    Decatur, Georgia, United States, 30030
  • Headlands Eastern MA LLC
    Plymouth, Massachusetts, United States, 02360
  • Advanced Memory Research Institute of NJ
    Toms River, New Jersey, United States, 08755
  • Alzheimer's Disease Research Center
    Albany, New York, United States, 12208
  • Flourish Research
    Matthews, North Carolina, United States, 28105
  • Neuro Behavioral Clinical Research, Inc.
    North Canton, Ohio, United States, 44720
  • Keystone Clinical Studies, LLC
    Plymouth Meeting, Pennsylvania, United States, 19462
  • Kerwin Medical Center
    Dallas, Texas, United States, 75231

Frequently Asked Questions

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.

The estimated enrollment for this trial is approximately 128 patients.

Please click here to learn more about PMN310.

Expanded access, sometimes referred to as compassionate use, is a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational product for treatment outside of clinical trials when no comparable or satisfactory alternative therapy options are available. ProMIS is not offering expanded access to PMN310, a humanized monoclonal antibody, at this time.

We understand that patients and healthcare providers may be interested in accessing investigational therapies, but we believe that participation in our ongoing clinical trials is currently the most appropriate way to evaluate the safety and efficacy of this product. This means that the investigational product is not available for use outside of clinical trials. We will re-evaluate this policy in the future as more information from our clinical trials is available. 

If you have questions about this policy, please contact us via email at info@promisneurosciences.com.  We anticipate acknowledging receipt of any messages sent to this email address within 10 business days of receipt. Please note that posting of this policy or contacting us will not result in access to the investigational product outside of a clinical trial.

This policy is provided in accordance with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 360bbb–0) as part of our commitment to transparency and regulatory compliance and is subject to change.

The safety and efficacy of this investigational product have not been determined. There is no guarantee that the investigational use listed will be filed with and/or approved for marketing by a regulatory agency.