ClinicalTrials.gg
CompletedNCT03538522Updated Jun 30, 2020

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

A Phase 2 interventional study of N-831(Traneurocin) 10 mg QD and NA-831 (Traneurocin) 20 mg QD in Mild Cognitive Impairment, Alzheimer Disease and Alzheimer Dementia, sponsored by Biomed Industries, Inc.. Completed at 2 sites in New Zealand. Open to participants aged 55 Years to 85 Years. Per ClinicalTrials.gov, last updated 2020-06-30.

Sponsored by Biomed Industries, Inc. · Phase 2, Interventional, and Other

Phase
Phase 2
Study type
Interventional
Enrollment
126
Allocation
Randomized
Ages
55 Years to 85 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 11 studies in Cognitive Dysfunction with a site in New Zealand — 3 open to participants now, 3 under way, none of them phase 3. Cognitive Dysfunction · New Zealand.

Started
2018
the only one that year
Phase 2
4 of 11
none open now
Registered
3rd of 11
by date
Lead sponsor
1 of 11
Biomed Industries, Inc.

Among the 11 studies in Cognitive Dysfunction with a site in New Zealand, this one is the only one that started in 2018, is one of 4 in phase 2, and was the 3rd registered.

Cognitive Dysfunction

3,872 studies on the registry are indexed under Cognitive Dysfunction; 1,119 are open to participants now.

This study's enrollment of 126 is above the median of 64 across 2,794 interventional studies indexed under Cognitive Dysfunction.

Browse Cognitive Dysfunction studies →

Open to participants now

3 of the 11 studies in Cognitive Dysfunction with a site in New Zealand are open now.

All 3 open studies →

A study can be open while its sites in New Zealand have not opened yet or have stopped. Only those recruiting at a site in New Zealand →

Who these studies take

Of the 750 Cognitive Dysfunction studies recruiting now, 362 (48%) set no upper age limit and 143 (19%) stop at 75 or younger; 46 take children under 18; 259 take healthy volunteers.

This study: 55 Years to 85 Years · all sexes · no healthy volunteers.

The full table on the hub →
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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 11 studies in Cognitive Dysfunction with a site in New Zealand, or all of them as a file.
02

Study summary

This study seeks to evaluate the efficacy and safety of NA-83 in subjects with mild cognitive impairment due to Alzheimer's Disease

Read the 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

03

Conditions studied

  • Mild Cognitive Impairment
  • Alzheimer Disease
  • Alzheimer Dementia
  • Dementia, Vascular
  • Dementia With Lewy Bodies
  • Cognitive Impairment
  • Tauopathies
  • Neurodegenerative Diseases
  • Neurocognitive Disorders
  • Cognitive Disorder
04

Who can participate

Ages eligible
55 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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. (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 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 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

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 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 (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 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 (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: (ALT) or aspartate transaminase (AST) >2 х the (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 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. 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.
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Postmenopausal

Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Phase 2
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
126 participants (actual)

Study arms

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

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

    Drug: N-831(Traneurocin) 10 mg QD

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

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

    Drug: NA-831 (Traneurocin) 20 mg QD

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

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

    Drug: NA-831 (Traneurocin) 40 mg QD

  • Placebo comparator
    Placebo

    Oral administration of placebo per day for 24 weeks

    Drug: Placebo oral capsule QD

Interventions

06

What researchers measure

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.

    Time frame: Week 24

Secondary outcomes

  1. 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.

    Time frame: Week 24

  2. 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.

    Time frame: Week 24

07

Study locations

2 sites
  • NeuroActiva-Clinical Research Unit
    Auckland, 1010, New Zealand
  • NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
    Auckland, New Zealand
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2018 to primary completion in Sep 2019, 12 months.

Of 41 industry-sponsored phase 2 interventional studies under Cognitive Dysfunction, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 39. This study's 12 months is below that.

Counting every sponsor, half of 186 studies reached it within 44 months; a quarter within 22 and three quarters within 62.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 16, 2018
First posted
May 29, 2018
StartActual
Sep 15, 2018
Primary completionActual
Sep 30, 2019
CompletionActual
Oct 30, 2019
Last update
Jun 30, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 30, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03538522
Lead sponsor
Biomed Industries, Inc.
Responsible party
Sponsor
First posted
May 29, 2018
Start date
Sep 15, 2018
Primary completion
Sep 30, 2019
Completion
Oct 30, 2019
Last update
Jun 30, 2020

Study contacts

Lloyd Tran, PhD
study director · Biomed Industries, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2019. You cannot join it, but the record below documents what was studied.

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