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

NCT ID: NCT03538522

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 126 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-15
• Study Completion Date: 2019-10-30

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

Conditions

Mild Cognitive Impairment; Alzheimer Disease; Alzheimer Dementia; Dementia, Vascular; Dementia With Lewy Bodies; Cognitive Impairment; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Cognitive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Low-dose N-831(Traneurocin)- 10 mg QD

Oral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks

Group Type: EXPERIMENTAL

N-831(Traneurocin) 10 mg QD

Intervention Type: DRUG

Oral administration of 10 mg capsule of NA-831 QD for 24 weeks

Medium-dose NA-831(Traneurocin)- 20 mg QD

Oral administration of 20 mg of NA-831(Traneurocin) per day for 24 weeks

Group Type: EXPERIMENTAL

NA-831 (Traneurocin) 20 mg QD

Intervention Type: DRUG

Oral administration of 20 mg capsule of NA-831 QD for 24 weeks

High-dose NA-831(Traneurocin)- 40 mg QD

Oral administration of 40 mg of NA-831(Traneurocin) per day for 24 weeks

Group Type: EXPERIMENTAL

NA-831 (Traneurocin) 40 mg QD

Intervention Type: DRUG

Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks

Placebo

Oral administration of placebo per day for 24 weeks

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule QD

Intervention Type: DRUG

Oral administration of oral placebo capsule QD or 24 weeks

Interventions

N-831(Traneurocin) 10 mg QD

Oral administration of 10 mg capsule of NA-831 QD for 24 weeks

Intervention Type: DRUG

NA-831 (Traneurocin) 20 mg QD

Oral administration of 20 mg capsule of NA-831 QD for 24 weeks

Intervention Type: DRUG

NA-831 (Traneurocin) 40 mg QD

Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks

Intervention Type: DRUG

Placebo oral capsule QD

Oral administration of oral placebo capsule QD or 24 weeks

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Is male or female, at 55-85 years of age (inclusive) at screening self-reported memory complaint, corroborated by spouse or companion as appropriate.

2. Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.

3. Mini-Mental State Exam (MMSE) ≥23

4. Center for Epidemiologic Studies-Depression (CES-D) score <27.

5. Normal thyroid function, defined as TSH, T3 and T4 within normal limits.

6. Agree not to consume alcoholic beverages within 8 hours of each study visit.

7. Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.

8. Able to read at a 6th grade level or equivalent

9. Female subjects must be surgically sterile or post-menopausal for at least 2 years. If <2 years post-menopausal, then a follicle stimulating hormone (FSH) ≥40 mIU/mL must be obtained.

10. If participant is receiving an acetylcholinesterase inhibitor or memantine, the dose must have been stable for at least three months before Screening

11. Must have a reliable and competent trial partner/informant who has a close relationship with the participant and is willing to accompany the participant to all required trial visits, and to monitor compliance of the administration of the trial medication

Exclusion Criteria

1. Subjects who have any significant, untreated psychiatric illness or any CNS condition (such as schizophrenia, Parkinson's disease, stroke, etc.) that could interfere with the study evaluations or procedures or which poses an additional risk.

2. Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission

3. History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.

4. Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year

5. History of seizures or epilepsy within the last 5 years

6. History of hepatitis or liver disease that has been active within the 6 months prior toScreening

7. History of malignancy occurring within the 5 years before Screening, except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or localized prostate carcinoma

8. Clinically significant vitamin B12 or folate deficiency in the 6 months before Screening

9. History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit

10. History of alcohol or substance abuse or dependence within the past year.

11. Has human immunodeficiency virus (HIV) by medical history

12. Acute infective sinusitis.

13. History or presence of an abnormality of the external or internal structures of the nose or nasopharynx, except for surgical correction of the nasal septum or a "broken nose" at least 2 years previously, or surgical repair of cleft palate when <30 years of age.

14. Use of medications that are known to cause frank obtundation of cognition

15. History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.

16. Untreated sleep apnea or treatment for sleep apnea for <3 months.

17. Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period

18. Use of allowed medications for chronic conditions at doses that have not been stable for at least 4 weeks prior to Screening, or use of AD medications at doses that have not been stable for at least 8 weeks prior to Screening

19. Abnormal clinical laboratory test results, specifically: Alanine transaminase (ALT) or aspartate transaminase (AST) >2 х the upper limit of normal (ULN),Hematology <80% the lower limit of normal, Creatinine ≥2 mg/dL and ,Other clinical laboratory values or vital signs considered clinically significant in the opinion of the Investigator.

20. Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.

21. Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.

22. Contraindications to study procedures

23. Use of any medications that, in the opinion of the Investigator, may contribute to cognitive impairment, put the participants at higher risk for adverse events (AEs), or impair the participant's ability to perform cognitive testing or complete study procedures.

• Minimum Eligible Age: 55 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Biomed Industries, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lloyd Tran, PhD

Role: STUDY_DIRECTOR

Biomed Industries, Inc.

Locations

NeuroActiva-Clinical Research Unit

Auckland, , New Zealand

NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd

Auckland, , New Zealand

Countries

New Zealand

Other Identifiers

NeuroActiva

Identifier Type: -

Identifier Source: org_study_id