Clinical trial NCT03538522: A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
Official title: A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, and Efficacy of NA-831 in Alzheimer Patients With Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Mild Cognitive Impairment
Alzheimer Disease
Alzheimer Dementia
Dementia, Vascular
Dementia With Lewy Bodies
Cognitive Impairment
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Cognitive Disorder
Lead sponsor: Biomed Industries, Inc.
Sponsor class: INDUSTRY
First posted: 2018-05-29
Enrollment: 126
Sex: ALL
Minimum age (years): 55
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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

Eligibility criteria: INCLUSION

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.

Primary outcomes:
measure: Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24
timeFrame: Week 24
Secondary outcomes:
measure: 1. Mean difference between the last (Week 24) and first (Week 2) postdose using Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) assessment
timeFrame: Week 24
measure: Assess the change from baseline in ADCS-ADL MCI at Week 24
timeFrame: Week 24
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: NeuroActiva-Clinical Research Unit
city: Auckland
country: New Zealand
facility: NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
Study officials:
affiliation: Biomed Industries, Inc.
name: Lloyd Tran, PhD
role: STUDY_DIRECTOR
References: