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

Phase 2

Completed

• Conditions: Alzheimer Dementia; Tauopathies; Neurodegenerative Diseases; Alzheimer Disease; Cognitive Disorder; Mild Cognitive Impairment; Dementia With Lewy Bodies; Cognitive Impairment; Dementia, Vascular; Neurocognitive Disorders
• Interventions: Drug: Placebo oral capsule QD; Drug: NA-831 (Traneurocin) 20 mg QD; Drug: NA-831 (Traneurocin) 40 mg QD; Drug: N-831(Traneurocin) 10 mg QD

• Registration Number: NCT03538522
• Lead Sponsor: Biomed Industries, Inc.

Brief 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

Study Timeline

• Study First Submitted: 2018-03-16
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Study Start: 2018-09-15
• Primary Completion: 2019-09-30
• Study Completion: 2019-10-30
• Status Verified: 2019-11
• Last Update Submitted: 2020-06-26
• Last Update Posted: 2020-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo oral capsule QD	Oral administration of placebo per day for 24 weeks
Medium-dose NA-831(Traneurocin)- 20 mg QD	NA-831 (Traneurocin) 20 mg QD	Oral administration of 20 mg of NA-831(Traneurocin) per day for 24 weeks
High-dose NA-831(Traneurocin)- 40 mg QD	NA-831 (Traneurocin) 40 mg QD	Oral administration of 40 mg of NA-831(Traneurocin) per day for 24 weeks
Low-dose N-831(Traneurocin)- 10 mg QD	N-831(Traneurocin) 10 mg QD	Oral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks

Primary Outcome Measures

Name	Time	Method
Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24	Week 24	To study to the change from baseline in the Clinical Dementia Rating scale-Sum of Boxes (CDR-SB) score at Week 2 and Week 24.; The CDR-SB is obtained through interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18 with the higher values represent worse outcome.

Secondary Outcome Measures

Name	Time	Method
1. Mean difference between the last (Week 24) and first (Week 2) postdose using Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) assessment	Week 24	To assess the Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) mean difference between the Week 2 and Week 24.; The CDR-SB is obtained through interviews of patients and informants, and cognitive functioning is rated in 6 domains of functioning: memory, orientation, judgment and problem solving, community affairs, home and hobbies, and personal care. Each domain is rated on a 5-point scale of functioning as follows: 0, no impairment; 0.5, questionable impairment; 1, mild impairment; 2, moderate impairment; and 3, severe impairment (personal care is scored on a 4-point scale without a 0.5 rating available). The CDR-SOB score is obtained by summing each of the domain box scores, with scores ranging from 0 to 18, with the higher values represent worse outcome.
Assess the change from baseline in ADCS-ADL MCI at Week 24	Week 24	Change from baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living Inventory (Mild Cognitive Impairment version) (ADCS-ADL MCI) at Week 24.; The Galasko method for Alzheimer Disease Cooperative Study (ADCS) will be used, which contains 23 items covering physical and mental functioning and independence in self-care. For Activities of Daily Living (ADLs), the scoring used was the following: 0 = no impairment, 1 = problem performing but no supervision or assistance needed, 2 = problem requiring supervision, 3 = problem with assistance needed, and 4 = unable to perform.; The scores range from 0 to 78, with higher values indicates greater disability.

Trial Locations

Locations (2)

NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd; 🇳🇿 Auckland, New Zealand

NeuroActiva-Clinical Research Unit; 🇳🇿 Auckland, New Zealand