A Phase 1 interventional study of NPT088 and Placebo in Alzheimer Disease, sponsored by Proclara Biosciences, Inc.. Completed at 23 sites in United States. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2019-08-15.
Sponsored by Proclara Biosciences, Inc. · Phase 1, Interventional, and Treatment
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).
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 83 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Proclara Biosciences, Inc. is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: For enrollment in the study, participants must
Exclusion Criteria: For enrollment in the study, participants must NOT:
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
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 · Drug: Placebo
IgG1 Fc-GAIM fusion protein, a recombinant fusion protein
Also known as: IgG1, fusion protein, GAIM, anti-Abeta, anti-Tau
Placebo
Number of patients with adverse events
Time frame: Baseline to Week 32
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
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
Change in CSF or blood biomarkers
Time frame: Up to Week 32
Plan to share: Undecided
This study is completed, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.
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Proclara Biosciences, Inc.