Clinical Trials Directory

Trials / Completed

CompletedNCT03538522

A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831

A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of NA-831 in Alzheimer Patients With Mild Cognitive Impairment

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
126 (actual)
Sponsor
Biomed Industries, Inc. · Industry
Sex
All
Age
55 Years – 85 Years
Healthy volunteers
Not accepted

Summary

This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive impairment due to Alzheimer's Disease

Detailed description

Mild cognitive impairment ("MCI") is defined as the "symptomatic pre-dementia stage" on the continuum of cognitive decline. Currently, no medications have proven effective for MCI. Preclinical experiments indicate that NA-831 is an endogenous small molecule that exhibits neuroprotection, neurogenesis, and cognitive protective properties across a range of disease models. NA-831 has been shown to be safe and well tolerated in healthy volunteers. This study seeks to evaluate the efficacy and safety of NA-83 in 126 subjects with mild cognitive impairment due to Alzheimer's Disease

Conditions

Interventions

TypeNameDescription
DRUGN-831(Traneurocin) 10 mg QDOral administration of 10 mg capsule of NA-831 QD for 24 weeks
DRUGNA-831 (Traneurocin) 20 mg QDOral administration of 20 mg capsule of NA-831 QD for 24 weeks
DRUGNA-831 (Traneurocin) 40 mg QDOral administration of 40 mg capsule of NA-831 QD or for 24 weeks
DRUGPlacebo oral capsule QDOral administration of oral placebo capsule QD or 24 weeks

Timeline

Start date
2018-09-15
Primary completion
2019-09-30
Completion
2019-10-30
First posted
2018-05-29
Last updated
2020-06-30

Locations

2 sites across 1 country: New Zealand

Source: ClinicalTrials.gov record NCT03538522. Inclusion in this directory is not an endorsement.