Mild Cognitive ImpairmentPhase 2NCT03538522
A Double-Blind, Placebo-Controlled Safety and Efficacy Study of NA-831
A Phase 2 study testing N-831(Traneurocin) 10 mg QD, NA-831 (Traneurocin) 20 mg QD and NA-831 (Traneurocin) 40 mg QD in people with Mild Cognitive Impairment and Alzheimer Disease, run by Biomed Industries, Inc. at 2 sites in New Zealand.
Trial 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 more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment, Alzheimer Disease, Alzheimer Dementia
- What is being tested?
- N-831(Traneurocin) 10 mg QD, NA-831 (Traneurocin) 20 mg QD and NA-831 (Traneurocin) 40 mg QD
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 2 sitesNew Zealand
- Study dates
- 15 Sep 2018to 30 Oct 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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
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- 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.
- Untreated sleep apnea or treatment for sleep apnea for <3 months.
- Clinically significant systemic illness or serious infection within 30 days prior to or during the screening period
- 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
- 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.
- Treatment with any investigational drug, biologic, or device within the previous 30 days prior to screening.
- Surgery involving general anesthesia within the past 3 months or planned surgery requiring general anesthesia during the study period.
- Contraindications to study procedures
- 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.
Trial locations and contacts
2 sites in 1 country.
New Zealand2 sites
NeuroActiva-Clinical Research Unit
Auckland, 1010
NeuroActiva Testing Facility of NeuroActiva (New Zealand) Ltd
Auckland
About this study
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
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
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Alzheimer Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Cognitive Impairment
- Being tested
- N-831(Traneurocin) 10 mg QD, NA-831 (Traneurocin) 20 mg QD, NA-831 (Traneurocin) 40 mg QD, Placebo oral capsule QD
- Medical subject headings
- Cognitive Dysfunction, Alzheimer Disease, Dementia, Vascular, Lewy Body Disease, Tauopathies, Neurodegenerative Diseases, Neurocognitive Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-831(Traneurocin) 10 mg QDDrug
Oral administration of 10 mg capsule of NA-831 QD for 24 weeks
NA-831 (Traneurocin) 20 mg QDDrug
Oral administration of 20 mg capsule of NA-831 QD for 24 weeks
NA-831 (Traneurocin) 40 mg QDDrug
Oral administration of 40 mg capsule of NA-831 QD or for 24 weeks
Placebo oral capsule QDDrug
Oral administration of oral placebo capsule QD or 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Low-dose N-831(Traneurocin)- 10 mg QD | Experimental | Oral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks Receives: 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 Receives: 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 Receives: Drug: NA-831 (Traneurocin) 40 mg QD |
| Placebo | Placebo comparator | Oral administration of placebo per day for 24 weeks Receives: Drug: Placebo oral capsule QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Week 24
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.
Measured: Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start15 Sep 2018
- Primary completion30 Sep 2019
- Study completion30 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biomed Industries, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lloyd Tran, PhD, Study director, Biomed Industries, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538522
- Sponsor's protocol ID
- NeuroActiva
- Status last verified
- Nov 2019
- First submitted
- 16 Mar 2018
- Last updated
- 30 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03538522
- Acronym / sponsor ID
- NeuroActiva
- Conditions
- Mild Cognitive Impairment, Alzheimer Disease, Alzheimer Dementia, Dementia, Vascular, Dementia With Lewy Bodies, Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Biomed Industries, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2018 (actual)
- Primary completion
- 30 Sep 2019 (actual)
- Study completion
- 30 Oct 2019 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low-dose N-831(Traneurocin)- 10 mg QD | Experimental | Drug: N-831(Traneurocin) 10 mg QDOral administration of 10 mg of NA-831 (Traneurocin) per day for 24 weeks |
| Medium-dose NA-831(Traneurocin)- 20 mg QD | Experimental | Drug: NA-831 (Traneurocin) 20 mg QDOral administration of 20 mg of NA-831(Traneurocin) per day for 24 weeks |
| High-dose NA-831(Traneurocin)- 40 mg QD | Experimental | Drug: NA-831 (Traneurocin) 40 mg QDOral administration of 40 mg of NA-831(Traneurocin) per day for 24 weeks |
| Placebo | Placebo comparator | Drug: Placebo oral capsule QDOral administration of placebo per day for 24 weeks |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (23 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| N-831(Traneurocin) 10 mg QDOral administration of 10 mg capsule of NA-831 QD for 24 weeks | Drug | Low-dose N-831(Traneurocin)- 10 mg QD |
| NA-831 (Traneurocin) 20 mg QDOral administration of 20 mg capsule of NA-831 QD for 24 weeks | Drug | Medium-dose NA-831(Traneurocin)- 20 mg QD |
| NA-831 (Traneurocin) 40 mg QDOral administration of 40 mg capsule of NA-831 QD or for 24 weeks | Drug | High-dose NA-831(Traneurocin)- 40 mg QD |
| Placebo oral capsule QDOral administration of oral placebo capsule QD or 24 weeks | Drug | Placebo |
Primary outcome
Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24
Time frame: 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.
2 secondary outcomes
1. Mean difference between the last (Week 24) and first (Week 2) postdose using Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) assessment
Time frame: Week 24
Assess the change from baseline in ADCS-ADL MCI at Week 24
Time frame: Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lloyd Tran, PhD study director
Biomed Industries, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing N-831(Traneurocin) 10 mg QD, NA-831 (Traneurocin) 20 mg QD and NA-831 (Traneurocin) 40 mg QD in people with Mild Cognitive Impairment and Alzheimer Disease, run by Biomed Industries, Inc. at 2 sites in New Zealand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Clinical Dementia Rating Scale- Sum of Boxes (CDR-SB) score at Week 24 (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2020.