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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03538522




Registration number
NCT03538522
Ethics application status
Date submitted
16/03/2018
Date registered
24/05/2018
Date last updated
25/05/2018

Titles & IDs
Public title
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
Scientific 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
Secondary ID [1] 0 0
NeuroActiva
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild Cognitive Impairment 0 0
Alzheimer Disease 0 0
Alzheimer Dementia 0 0
Dementia, Vascular 0 0
Dementia With Lewy Bodies 0 0
Cognitive Impairment 0 0
Tauopathies 0 0
Neurodegenerative Diseases 0 0
Neurocognitive Disorders 0 0
Cognitive Disorder 0 0
Condition category
Condition code
Neurological 0 0 0 0
Alzheimer's disease
Neurological 0 0 0 0
Dementias
Mental Health 0 0 0 0
Other mental health disorders
Neurological 0 0 0 0
Neurodegenerative diseases
Mental Health 0 0 0 0
Learning disabilities
Neurological 0 0 0 0
Other neurological disorders
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - N-831(Traneurocin) 10 mg QD
Treatment: Drugs - NA-831 (Traneurocin) 20 mg QD
Treatment: Drugs - NA-831 (Traneurocin) 40 mg QD
Treatment: Drugs - Placebo oral capsule QD

Experimental: Low-dose N-831(Traneurocin)- 10 mg QD - Oral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks

Experimental: Medium-dose NA-831(Traneurocin)- 20 mg QD - Oral administration of 20 mg of NA-831(Traneurocin) per day for 24 weeks

Experimental: High-dose NA-831(Traneurocin)- 40 mg QD - Oral administration of 40 mg of NA-831(Traneurocin) per day for 24 weeks

Placebo Comparator: Placebo - Oral administration of placebo per day for 24 weeks


Treatment: Drugs: N-831(Traneurocin) 10 mg QD
Oral administration of 10 mg capsule of NA-831 QD for 24 weeks

Treatment: Drugs: NA-831 (Traneurocin) 20 mg QD
Oral administration of 20 mg capsule of NA-831 QD for 24 weeks

Treatment: Drugs: NA-831 (Traneurocin) 40 mg QD
Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks

Treatment: Drugs: Placebo oral capsule QD
Oral administration of oral placebo capsule QD or 24 weeks

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Week 24
Secondary outcome [1] 0 0
1. Mean difference between the last (Week 24) and first (Week 2) postdose using Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) assessment - 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.
Timepoint [1] 0 0
Week 24
Secondary outcome [2] 0 0
Assess the change from baseline in ADCS-ADL MCI at 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.
Timepoint [2] 0 0
Week 24

Eligibility
Key inclusion 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 ? 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 age
55 Years
Maximum age
85 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Other
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Investigator Site of NeuroActiva (Australia) Pte - Melbourne
Recruitment postcode(s) [1] 0 0
3052 - Melbourne
Recruitment outside Australia
Country [1] 0 0
New Zealand
State/province [1] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
NeuroActiva, Inc.
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Florey Institute of Neuroscience and Mental Health
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT03538522
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Brian Tran, MD
Address 0 0
Country 0 0
Phone 0 0
+61-3-8400-4628
Fax 0 0
Email 0 0
btran@neuroactiva.com
Contact person for scientific queries

No data has been provided for results reporting
Summary results
Not applicable