search
Back to results

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

Primary Purpose

Alzheimer Disease

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
NPT088
Placebo
Sponsored by
Proclara Biosciences, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring GAIM, amyloid, anti-aBeta, anti-tau

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • ATP Clinical Research, Inc.
  • Neurology Center of North Orange County
  • Collaborative Neuroscience Network
  • Southern California Research
  • Associated Neurologists of Southern Connecticut
  • JEM Research Institute
  • Indago Research and Health Center
  • Alzheimer's Research and Treatment Center
  • Miami Jewish Health Systems
  • Medical Research Group of Central Florida
  • Compass Research
  • Progressive Medical Research
  • Axiom Clinical Research
  • Compass-The Villages
  • Medical Research and Health Education Foundation
  • NeuroStudies LLC
  • Princeton Medical Institute
  • Neurological Associates of Albany
  • Integrative Clinical Trials, Inc.
  • Alzheimer's Memory Center
  • Lehigh Center for Clinical Research
  • Abington Neurological Associates, Ltd
  • Neurology Clinic, PC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Cohort 1

Cohort 2

Cohort 3

Cohort 4

Arm Description

Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months

Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months

Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months

Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months

Outcomes

Primary Outcome Measures

Number of patients with adverse events

Secondary Outcome Measures

Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Multiple dose PK CSF concentrations of NPT088
Multiple dose immunogenicity of NPT088

Full Information

First Posted
December 23, 2016
Last Updated
August 14, 2019
Sponsor
Proclara Biosciences, Inc.
Collaborators
Alzheimer's Association
search

1. Study Identification

Unique Protocol Identification Number
NCT03008161
Brief Title
Multiple Dose Safety Study of NPT088 in Patients With Mild to Moderate Probable Alzheimer's Disease
Official Title
A Phase 1 Randomized, Double-Blind, Placebo-Controlled, Multiple Dose, Dose Escalation Study of NPT088 in Patients With Probable Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2016 (Actual)
Primary Completion Date
February 6, 2019 (Actual)
Study Completion Date
February 6, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Proclara Biosciences, Inc.
Collaborators
Alzheimer's Association

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease
Keywords
GAIM, amyloid, anti-aBeta, anti-tau

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months
Intervention Type
Drug
Intervention Name(s)
NPT088
Other Intervention Name(s)
IgG1, fusion protein, GAIM, anti-Abeta, anti-Tau
Intervention Description
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Number of patients with adverse events
Time Frame
Baseline to Week 32
Secondary Outcome Measure Information:
Title
Multiple dose pharmacokinetic (PK) serum concentrations of NPT088
Time Frame
Up to Week 32
Title
Multiple dose PK CSF concentrations of NPT088
Time Frame
Up to Week 32
Title
Multiple dose immunogenicity of NPT088
Time Frame
Up to Week 32
Other Pre-specified Outcome Measures:
Title
Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas
Time Frame
Baseline and Week 24
Title
Change from baseline in [18F] MNI-960 PET imaging in certain brain areas
Time Frame
Baseline and Week 24
Title
Change in CSF or blood biomarkers
Time Frame
Up to Week 32

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Proclara Biosciences
Organizational Affiliation
Proclara
Official's Role
Study Director
Facility Information:
Facility Name
ATP Clinical Research, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Neurology Center of North Orange County
City
Fullerton
State/Province
California
ZIP/Postal Code
92835
Country
United States
Facility Name
Collaborative Neuroscience Network
City
Long Beach
State/Province
California
ZIP/Postal Code
90806
Country
United States
Facility Name
Southern California Research
City
Simi Valley
State/Province
California
ZIP/Postal Code
93065
Country
United States
Facility Name
Associated Neurologists of Southern Connecticut
City
Fairfield
State/Province
Connecticut
ZIP/Postal Code
06824
Country
United States
Facility Name
JEM Research Institute
City
Atlantis
State/Province
Florida
ZIP/Postal Code
33462
Country
United States
Facility Name
Indago Research and Health Center
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Alzheimer's Research and Treatment Center
City
Lake Worth
State/Province
Florida
ZIP/Postal Code
33449
Country
United States
Facility Name
Miami Jewish Health Systems
City
Miami
State/Province
Florida
ZIP/Postal Code
33137
Country
United States
Facility Name
Medical Research Group of Central Florida
City
Orange City
State/Province
Florida
ZIP/Postal Code
32763
Country
United States
Facility Name
Compass Research
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Progressive Medical Research
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32137
Country
United States
Facility Name
Axiom Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Compass-The Villages
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Medical Research and Health Education Foundation
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31909
Country
United States
Facility Name
NeuroStudies LLC
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Princeton Medical Institute
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States
Facility Name
Neurological Associates of Albany
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Integrative Clinical Trials, Inc.
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11229
Country
United States
Facility Name
Alzheimer's Memory Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28270
Country
United States
Facility Name
Lehigh Center for Clinical Research
City
Allentown
State/Province
Pennsylvania
ZIP/Postal Code
18104
Country
United States
Facility Name
Abington Neurological Associates, Ltd
City
Willow Grove
State/Province
Pennsylvania
ZIP/Postal Code
19090
Country
United States
Facility Name
Neurology Clinic, PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
24768993
Citation
Krishnan R, Tsubery H, Proschitsky MY, Asp E, Lulu M, Gilead S, Gartner M, Waltho JP, Davis PJ, Hounslow AM, Kirschner DA, Inouye H, Myszka DG, Wright J, Solomon B, Fisher RA. A bacteriophage capsid protein provides a general amyloid interaction motif (GAIM) that binds and remodels misfolded protein assemblies. J Mol Biol. 2014 Jun 26;426(13):2500-19. doi: 10.1016/j.jmb.2014.04.015. Epub 2014 Apr 22.
Results Reference
background
PubMed Identifier
29067301
Citation
Levenson JM, Schroeter S, Carroll JC, Cullen V, Asp E, Proschitsky M, Chung CH, Gilead S, Nadeem M, Dodiya HB, Shoaga S, Mufson EJ, Tsubery H, Krishnan R, Wright J, Solomon B, Fisher R, Gannon KS. NPT088 reduces both amyloid-beta and tau pathologies in transgenic mice. Alzheimers Dement (N Y). 2016 Jul 14;2(3):141-155. doi: 10.1016/j.trci.2016.06.004. eCollection 2016 Sep.
Results Reference
background
PubMed Identifier
28093972
Citation
Krishnan R, Hefti F, Tsubery H, Lulu M, Proschitsky M, Fisher R. Conformation as the Therapeutic Target for Neurodegenerative Diseases. Curr Alzheimer Res. 2017;14(4):393-402. doi: 10.2174/1567205014666170116152622.
Results Reference
background

Learn more about this trial

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

We'll reach out to this number within 24 hrs