Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease

August 14, 2019 updated by: Proclara Biosciences, Inc.

A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease

The purpose of the study is to evaluate the safety and tolerability of multiple doses of NPT088 in patients with mild to moderate probable Alzheimer's Disease. The study will also evaluate the pharmacokinetics, immunogenicity and exploratory pharmacodynamic characteristics of multiple doses of NPT088.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This study is a multicenter Phase 1, randomized, double-blind, placebo-controlled, multiple-dose, dose-escalation safety and tolerability study of NPT088 or placebo in patients with Probable AD with a MMSE score of 16-27. Enrolled patients will receive an intravenous infusion of NPT088 or placebo once a month for six months during this study. Four dose cohorts are planned with the first two cohorts enrolling 9 patients each (6 NPT088: 3 placebo) and the final two cohorts enrolling 24 patients each (16 NPT088: 8 placebo) for a total of 66 patients (44 NPT088: 22 placebo).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
83

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Costa Mesa, California, United States, 92626
        • ATP Clinical Research, Inc.
      • Fullerton, California, United States, 92835
        • Neurology Center of North Orange County
      • Long Beach, California, United States, 90806
        • Collaborative Neuroscience Network
      • Simi Valley, California, United States, 93065
        • Southern California Research
    • Connecticut
      • Fairfield, Connecticut, United States, 06824
        • Associated Neurologists of Southern Connecticut
    • Florida
      • Atlantis, Florida, United States, 33462
        • JEM Research Institute
      • Hialeah, Florida, United States, 33012
        • Indago Research and Health Center
      • Lake Worth, Florida, United States, 33449
        • Alzheimer's Research and Treatment Center
      • Miami, Florida, United States, 33137
        • Miami Jewish Health Systems
      • Orange City, Florida, United States, 32763
        • Medical Research Group of Central Florida
      • Orlando, Florida, United States, 32806
        • Compass Research
      • Port Orange, Florida, United States, 32137
        • Progressive Medical Research
      • Tampa, Florida, United States, 33609
        • Axiom Clinical Research
      • The Villages, Florida, United States, 32162
        • Compass-The Villages
    • Georgia
      • Columbus, Georgia, United States, 31909
        • Medical Research and Health Education Foundation
      • Decatur, Georgia, United States, 30033
        • NeuroStudies LLC
    • New Jersey
      • Princeton, New Jersey, United States, 08540
        • Princeton Medical Institute
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany
      • Brooklyn, New York, United States, 11229
        • Integrative Clinical Trials, Inc.
    • North Carolina
      • Charlotte, North Carolina, United States, 28270
        • Alzheimer's Memory Center
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18104
        • Lehigh Center for Clinical Research
      • Willow Grove, Pennsylvania, United States, 19090
        • Abington Neurological Associates, LTD
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Neurology Clinic, PC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

46 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria: For enrollment in the study, participants must

  • be between 50 and 85 years of age, inclusive
  • have a Mini Mental State Examination (MMSE) scores between 16-27 (inclusive)
  • have a Modified Hachinski Score of less than or equal to 4
  • have a diagnosis of Probable Alzheimer's Disease (AD) according to consensus criteria defined by the National Institute on Aging-Alzheimer's Association work group
  • have a Clinical Dementia Rating Scale (CDR) of 0.5 or 1.0, with the memory box score equal to or greater than 0.5
  • have a positive florbetapir positron emission tomography (PET) amyloid scan
  • consent to apolipoprotein E (ApoE) genotyping
  • be willing to undergo repeat Magnetic Resonance Imaging (MRI) and PET imaging
  • be on stable doses of allowed medications for at least 30 days prior to Screening. Concurrent treatment with cholinesterase inhibitors and/or memantine is allowed
  • be in good healthy apart from the clinical diagnosis of AD
  • have a dedicated Caregiver who provides care at least 4 hours a day for 4 days a week and will provide informed consent for their participation

Exclusion Criteria: For enrollment in the study, participants must NOT:

  • have a history of, or screening MRI indicative of any significant brain abnormality
  • have any major medical illness or unstable medical condition or in the opinion of the Investigator have any reason that may interfere with the participants ability to comply with the study procedures and abide by study restrictions or with the ability to interpret safety data
  • reside in a nursing home or need 24-hour care and supervision
  • take excluded medications
  • have exclusionary values on the Screening blood and urine sample
  • have been treated with immunomodulators to treat AD
  • have participated in an investigational drug or device study within 90 days
  • have a known allergy to study drug

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cohort 1
Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months
Drug: Placebo
Placebo
Drug: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Experimental: Cohort 2
Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months
Drug: Placebo
Placebo
Drug: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Experimental: Cohort 3
Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months
Drug: Placebo
Placebo
Drug: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Experimental: Cohort 4
Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months
Drug: Placebo
Placebo
Drug: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Number of patients with adverse events
Time Frame: Baseline to Week 32
Baseline to Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Time Frame: Up to Week 32
Up to Week 32
Multiple dose PK CSF concentrations of NPT088
Time Frame: Up to Week 32
Up to Week 32
Multiple dose immunogenicity of NPT088
Time Frame: Up to Week 32
Up to Week 32

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas
Time Frame: Baseline and Week 24
Baseline and Week 24
Change from baseline in [18F] MNI-960 PET imaging in certain brain areas
Time Frame: Baseline and Week 24
Baseline and Week 24
Change in CSF or blood biomarkers
Time Frame: Up to Week 32
Up to Week 32

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Proclara Biosciences, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Alzheimer's Association

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Proclara Biosciences, Proclara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 6, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 6, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 23, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 2, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 15, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NPT088-CL002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings