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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03008161
Recruitment Status : Completed
First Posted : January 2, 2017
Last Update Posted : August 15, 2019
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Proclara Biosciences, Inc.

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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Drug: NPT088 Drug: Placebo Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 83 participants
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
Actual Study Start Date : December 2016
Actual Primary Completion Date : February 6, 2019
Actual Study Completion Date : February 6, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




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

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

Other Outcome Measures:
  1. Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas [ Time Frame: Baseline and Week 24 ]
  2. Change from baseline in [18F] MNI-960 PET imaging in certain brain areas [ Time Frame: Baseline and Week 24 ]
  3. Change in CSF or blood biomarkers [ Time Frame: Up to Week 32 ]


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.


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Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
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

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


Locations
Show Show 23 study locations
Sponsors and Collaborators
Proclara Biosciences, Inc.
Alzheimer's Association
Investigators
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Study Director: Proclara Biosciences Proclara

Publications:
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Responsible Party: Proclara Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT03008161    
Other Study ID Numbers: NPT088-CL002
First Posted: January 2, 2017    Key Record Dates
Last Update Posted: August 15, 2019
Last Verified: August 2019
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:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders