Welcome to the Prothena ASCENT-2 clinical trial website!

The ASCENT-2 clinical trial is a Phase 1 study evaluating the safety of PRX012, a subcutaneously administered investigational drug intended for patients with Alzheimer’s disease.

About the ASCENT-2 Clinical Trial

The ASCENT-2 clinical trial is evaluating an investigational drug called PRX012.

Inclusion/Exclusion Criteria

The ASCENT-2 clinical trial is looking for participants from 55 to 85 years old with diagnosed mild Alzheimer’s disease (AD) or mild cognitive impairment due to AD.

Clinical Trial Locations

The ASCENT-2 clinical trial will take place at several clinical trial sites. Click here to view our map and find a participating site location near you or your patient.

Selected Key Eligibility Criteria

ASCENT-2 Clinical Trial

Key Inclusion Criteria

  • Adults 55 to 85 years of age
  • Diagnostic criteria of AD based on one of the following:
    • Probable AD with evidence of the AD pathophysiological process
    • Mild cognitive impairment due to AD
  • Gradual and progressive change in memory function for ≥6 months

This is not a complete list of eligibility criteria.
Please contact a clinical trial representative for more information.

About the ASCENT-2 Clinical Trial

ASCENT-2 Clinical Trial

Phase 1, placebo-controlled, multiple ascending dose clinical trial of PRX012 in adults aged 55 to 85 with probable AD or mild cognitive impairment due to AD.

Primary Objective

To evaluate the safety, tolerability, and immunogenicity of PRX012 after multiple subcutaneous doses.

Clinical Trial Design

Eligible participants are randomized to receive either placebo or PRX012 at predetermined dose strengths. Participants will be monitored for safety and tolerability throughout the clinical trial, including a follow-up visit after the final dose. Pharmacokinetics (PK) and pharmacodynamics (PD) will also be measured in all participants during the treatment period of the clinical trial.

About the Investigational Drug PRX012

PRX012 is a humanized IgG1 monoclonal antibody designed to target and clear aggregated toxic forms of amyloid beta, including soluble oligomers and protofibrils and insoluble plaque.

How is the study drug given?

The study drug is given subcutaneously as an injection into the fatty tissue of the arm, just under the skin.

What to Expect During the ASCENT-2 Clinical Trial

Clinical Trial Duration

ASCENT-2 Clinical Trial

Participants will take part in the ASCENT-2 clinical trial for approximately 1 year and have in-person visits for safety, PK and PD assessments.

How do I refer my patients?

Please direct your patient to the ASCENT-AD.com website and they can complete the form to apply.

Or you may contact the trial team at (877) 618-3004.

Common Questions

Will compensation be provided to participants?

Compensation will be provided for clinical trial participation, depending on the study site location. Clinical trial related travel reimbursements may be provided. No health insurance is needed.

What is the length of the ASCENT clinical trials?

ASCENT-2 Clinical Trial: Participants will be enrolled for approximately 1 year.

WHERE WE ARE

SITE LOCATIONS

Current site locations are listed below and more may be added at any time.

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