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

This study is currently recruiting participants.
Verified September 2017 by Proclara Biosciences, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT03008161
First Posted: January 2, 2017
Last Update Posted: September 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Proclara Biosciences, Inc.
  Purpose
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.

Condition Intervention Phase
Alzheimer Disease Drug: NPT088 Drug: Placebo Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Proclara Biosciences, Inc.:

Primary Outcome Measures:
  • Number of patients with adverse events [ Time Frame: Baseline to Week 32 ]

Secondary Outcome Measures:
  • Multiple dose pharmacokinetic (PK) serum concentrations of NPT088 [ Time Frame: Up to Week 32 ]
  • Multiple dose PK CSF concentrations of NPT088 [ Time Frame: Up to Week 32 ]
  • Multiple dose immunogenicity of NPT088 [ Time Frame: Up to Week 32 ]

Other Outcome Measures:
  • Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas [ Time Frame: Baseline and Week 24 ]
  • Change from baseline in [18F] MNI-960 PET imaging in certain brain areas [ Time Frame: Baseline and Week 24 ]

Estimated Enrollment: 66
Study Start Date: December 2016
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: July 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Drug: Placebo
Placebo
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: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Drug: Placebo
Placebo
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: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Drug: Placebo
Placebo
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: NPT088
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Other Names:
  • IgG1
  • fusion protein
  • GAIM
  • anti-Abeta
  • anti-Tau
Drug: Placebo
Placebo

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).
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03008161


Contacts
Contact: Clinical Trials Inquiry 6179417021 clintrialquery@proclarabio.com

Locations
United States, California
Collaborative Neuroscience Network Recruiting
Long Beach, California, United States, 90806
Principal Investigator: Omidvar         
Southern California Research Recruiting
Simi Valley, California, United States, 93065
Principal Investigator: Summers         
United States, Connecticut
Associated Neurologists of Southern Connecticut Recruiting
Fairfield, Connecticut, United States, 06824
Principal Investigator: Kadimi         
United States, Florida
JEM Research Institute Recruiting
Atlantis, Florida, United States, 33462
Principal Investigator: Goldstein         
Indago Research and Health Center Recruiting
Hialeah, Florida, United States, 33012
Principal Investigator: Perez         
Alzheimer's Research and Treatment Center Recruiting
Lake Worth, Florida, United States, 33449
Principal Investigator: Watson         
Miami Jewish Health Systems Recruiting
Miami, Florida, United States, 33137
Principal Investigator: Agronin         
Medical Research Group of Central Florida Recruiting
Orange City, Florida, United States, 32763
Principal Investigator: Thebaud         
Compass Research Recruiting
Orlando, Florida, United States, 32806
Principal Investigator: Curtis         
Axiom Clinical Research Recruiting
Tampa, Florida, United States, 33609
Principal Investigator: Steen         
Compass-The Villages Recruiting
The Villages, Florida, United States, 32162
Principal Investigator: Subich         
United States, Georgia
Medical Research and Health Education Foundation Recruiting
Columbus, Georgia, United States, 31909
Principal Investigator: Liss         
NeuroStudies LLC Recruiting
Decatur, Georgia, United States, 30033
Principal Investigator: Nash         
United States, New Jersey
Princeton Medical Institute Recruiting
Princeton, New Jersey, United States, 08540
Principal Investigator: Apter         
United States, New York
Neurological Associates of Albany Recruiting
Albany, New York, United States, 12208
Principal Investigator: Holub         
Integrative Clinical Trials, Inc. Recruiting
Brooklyn, New York, United States, 11229
Principal Investigator: Yuryev         
United States, North Carolina
Alzheimer's Memory Center Recruiting
Charlotte, North Carolina, United States, 28270
Principal Investigator: Bolouri         
United States, Pennsylvania
Lehigh Center for Clinical Research Recruiting
Allentown, Pennsylvania, United States, 18104
Principal Investigator: Gross         
Sponsors and Collaborators
Proclara Biosciences, Inc.
Alzheimer's Association
Investigators
Study Director: Proclara Biosciences Proclara
  More Information

Publications:
Responsible Party: Proclara Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03008161     History of Changes
Other Study ID Numbers: NPT088-CL002
First Submitted: December 23, 2016
First Posted: January 2, 2017
Last Update Posted: September 6, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Proclara Biosciences, Inc.:
GAIM
amyloid
anti-aBeta
anti-tau

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders