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| Name | Class |
|---|---|
| Alzheimer's Association | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive monthly IV infusions of either low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months |
|
| Cohort 2 | Experimental | Participants will receive monthly IV infusions of either mid-low dose NPT088 (6 participants) or placebo (3 participants) for a total of 6 months |
|
| Cohort 3 | Experimental | Participants will receive monthly IV infusions of either mid-high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months |
|
| Cohort 4 | Experimental | Participants will receive monthly IV infusions of either high dose NPT088 (16 participants) or placebo (8 participants) for a total of 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NPT088 | Drug | IgG1 Fc-GAIM fusion protein, a recombinant fusion protein |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients with adverse events | Baseline to Week 32 |
| Measure | Description | Time Frame |
|---|---|---|
| Multiple dose pharmacokinetic (PK) serum concentrations of NPT088 | Up to Week 32 | |
| Multiple dose PK CSF concentrations of NPT088 | Up to Week 32 | |
| Multiple dose immunogenicity of NPT088 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in florbetapir-fluorine-18 positron emission tomography (PET) imaging in certain brain areas | Baseline and Week 24 | |
| Change from baseline in [18F] MNI-960 PET imaging in certain brain areas | Baseline and Week 24 |
Inclusion Criteria: For enrollment in the study, participants must
Exclusion Criteria: For enrollment in the study, participants must NOT:
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| Name | Affiliation | Role |
|---|---|---|
| Proclara Biosciences | Proclara | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATP Clinical Research, Inc. | Costa Mesa | California | 92626 | United States | ||
| Neurology Center of North Orange County |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24768993 | Background | 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. | |
| 29067301 |
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| Placebo | Drug | Placebo |
|
| Up to Week 32 |
| Change in CSF or blood biomarkers | Up to Week 32 |
| Fullerton |
| California |
| 92835 |
| United States |
| Collaborative Neuroscience Network | Long Beach | California | 90806 | United States |
| Southern California Research | Simi Valley | California | 93065 | United States |
| Associated Neurologists of Southern Connecticut | Fairfield | Connecticut | 06824 | United States |
| JEM Research Institute | Atlantis | Florida | 33462 | United States |
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States |
| Alzheimer's Research and Treatment Center | Lake Worth | Florida | 33449 | United States |
| Miami Jewish Health Systems | Miami | Florida | 33137 | United States |
| Medical Research Group of Central Florida | Orange City | Florida | 32763 | United States |
| Compass Research | Orlando | Florida | 32806 | United States |
| Progressive Medical Research | Port Orange | Florida | 32137 | United States |
| Axiom Clinical Research | Tampa | Florida | 33609 | United States |
| Compass-The Villages | The Villages | Florida | 32162 | United States |
| Medical Research and Health Education Foundation | Columbus | Georgia | 31909 | United States |
| NeuroStudies LLC | Decatur | Georgia | 30033 | United States |
| Princeton Medical Institute | Princeton | New Jersey | 08540 | United States |
| Neurological Associates of Albany | Albany | New York | 12208 | United States |
| Integrative Clinical Trials, Inc. | Brooklyn | New York | 11229 | United States |
| Alzheimer's Memory Center | Charlotte | North Carolina | 28270 | United States |
| Lehigh Center for Clinical Research | Allentown | Pennsylvania | 18104 | United States |
| Abington Neurological Associates, Ltd | Willow Grove | Pennsylvania | 19090 | United States |
| Neurology Clinic, PC | Cordova | Tennessee | 38018 | United States |
| Background |
| 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. |
| 28093972 | Background | 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. |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| ID | Term |
|---|---|
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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