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

NCT03538522 | Completed Phase 2 DMC

• 1 other identifier: NeuroActiva
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 2

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

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at 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.

  Week 24

Secondary Outcomes (2)

• 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

• Assess the change from baseline in ADCS-ADL MCI at Week 24

  Week 24

Study Arms (4)

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

EXPERIMENTAL

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

Drug: N-831(Traneurocin) 10 mg QD

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

EXPERIMENTAL

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

Drug: NA-831 (Traneurocin) 20 mg QD

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

EXPERIMENTAL

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

Drug: NA-831 (Traneurocin) 40 mg QD

Placebo

PLACEBO COMPARATOR

Oral administration of placebo per day for 24 weeks

Drug: Placebo oral capsule QD

Interventions

N-831(Traneurocin) 10 mg QD DRUG

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

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

NA-831 (Traneurocin) 20 mg QD DRUG

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

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

NA-831 (Traneurocin) 40 mg QD DRUG

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

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

Placebo oral capsule QD DRUG

Oral administration of oral placebo capsule QD or 24 weeks

Placebo

Eligibility Criteria

• Age: 55 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Is male or female, at 55-85 years of age (inclusive) at screening self-reported memory complaint, corroborated by spouse or companion as appropriate.
• Wechsler Memory Scale III (WMS-III) age-adjusted Logical Memory II score ≤ 5.
• Mini-Mental State Exam (MMSE) ≥23
• Center for Epidemiologic Studies-Depression (CES-D) score \<27.
• Normal thyroid function, defined as TSH, T3 and T4 within normal limits.
• Agree not to consume alcoholic beverages within 8 hours of each study visit.
• Willing and able to sign informed consent and complete the CTB and all other tests and procedures as listed in the protocol.
• Able to read at a 6th grade level or equivalent
• 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.
• If participant is receiving an acetylcholinesterase inhibitor or memantine, the dose must have been stable for at least three months before Screening
• 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

You may not qualify if:

• 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.
• Evidence of a clinically relevant or unstable psychiatric disorder, excluding major depression in remission
• History of significant head trauma followed by persistent neurologic defaults or known structural brain abnormalities.
• Have had a stroke or Transient Ischemic Attack (TIA) or unexplained loss of consciousness in the past 1 year
• History of seizures or epilepsy within the last 5 years
• History of hepatitis or liver disease that has been active within the 6 months prior toScreening
• 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
• Clinically significant vitamin B12 or folate deficiency in the 6 months before Screening
• History of unstable angina, myocardial infarction, chronic heart failure or clinically significant conduction abnormalities within 1 year prior to Screening Visit
• History of alcohol or substance abuse or dependence within the past year.
• Has human immunodeficiency virus (HIV) by medical history
• Acute infective sinusitis.
• 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.
• Use of medications that are known to cause frank obtundation of cognition
• History of or current significant systemic disease judged to interfere with the study evaluations or likely to be a safety concern.

Sponsors & Collaborators

• Biomed Industries, Inc.: lead

Study Sites (2)

NeuroActiva-Clinical Research Unit

Auckland, 1010, New Zealand

Location

NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd

Auckland, New Zealand

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Alzheimer Disease; Dementia, Vascular; Lewy Body Disease; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Mental Disorders; Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies

Study Officials

• Lloyd Tran, PhD

  Biomed Industries, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2018
• First Posted: May 29, 2018
• Study Start: September 15, 2018
• Primary Completion: September 30, 2019
• Study Completion: October 30, 2019
• Last Updated: June 30, 2020

Record last verified: 2019-11

Locations

NZ (2)