Alzheimer DiseasePhase 1NCT06194552
A Multiple Dose Study of the Safety and Pharmacokinetics of NTRX-07
A Phase 1 study testing NTRX-07 in people with Alzheimer Disease, run by NeuroTherapia, Inc. at 2 sites in 2 countries.
Trial summary
This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Alzheimer Disease
- What is being tested?
- NTRX-07
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 6 Sep 2022to 30 Jun 2023
- Phase
- Phase 1
- 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 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant must be 45 80 years of age inclusive, at the time of signing the informed consent
- Cohorts A-C participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Cohort D - AD as characterized by the following clinical, cognitive, and functional criteria.
- Diagnosis of a clinical syndrome of cognitive impairment consistent with prodromal AD per International Working Group (IWG) diagnostic criteria or mild AD per National Institute on Aging - Alzheimer's Association (NIAA-AA) diagnostic criteria
- Self or informant report of memory decline
- Mini-Mental State Examination (MMSE) scores between 18-27 inclusive within the last 4 months
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- Objective memory loss by education-adjusted Wechsler Memory Scale Logical Memory II consistent with mild cognitive impairment with Alzheimer's disease (MCI AD) or mild AD
- Absence of significant levels of impairment in other cognitive assessments
- Cohort D - Previous brain imaging study, such as magnetic resonance imaging (MRI) and/or computed tomography (CT), consistent with a diagnosis of probably AD without any other clinically significant co-morbid pathologies within 12 months prior to the Screening Visit. If there has been a significant change in clinical status suggestive of stroke or other possible central neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, the scan should be repeated during Screening procedures if considered appropriate by the Investigator OR Screening cerebrospinal fluid (CSF) results consistent with the presence of amyloid pathology.
- Cohort D - No active depression and a Geriatric Depression Score of <6.
- Cohort D - Absence of other (non-AD) types of dementia.
- Cohort D - Participants previously enrolled in an AD clinical trial involving a disease modifying or symptomatic therapeutic agent may enroll in this study if treatment with the symptomatic therapeutic agent ended more than 6 months before the first dose of NTRX 07-SDD in this study.
- Body weight within 55 110 kg and body mass index (BMI) within the range 18 35 kg/m2 (inclusive)
- Male or Female
- The effects of NTRX 07 on pregnancy, fetal development, and excretion in breast milk is currently unknown. Contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the subject information sheet, informed consent form (ICF) and in this protocol.
Who cannot join
- Reported history or presence of clinically significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. Participants with stable well controlled conditions may be accepted on review with the Investigator and sponsor.
- Reported current or chronic history of clinically significant liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
- Reported hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Cohort D - Reside in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision. Participant may reside in such facilities provided continuous direct medical care is not required.
- Cohort D - Unable to provide for self for basic activities of daily living.
- Cohort D - Major structural brain disease by reported history or chart review (eg, ischemic infarcts, subdural hematoma, hemorrhage, hydrocephalus, brain tumors, multiple subcortical ischemic lesions, or a single lesion in a critical region eg, thalamus, hippocampus).
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- Any other reported history of central nervous system (CNS) trauma (eg, contusion), or infections that affect brain function (eg, human immunodeficiency virus [HIV], syphilis), history of seizures
- Diagnosis of schizophrenia
- Any reported history from patient, family, or on supplied chart review or current suicide risk
- Cohort D - Diagnosis of a dementia-related CNS disease other than AD (eg, Parkinson's Disease, Huntington's Disease, frontotemporal dementia, multi-infarct dementia, dementia with Lewy bodies, normal pressure hydrocephalus)
- Reported past or intended use of over-the-counter or prescription medication including herbal medications within 7 days prior to dosing. Specific medications listed in Section Concomittant Therapy may be allowed.
- Reported treatment with biologic agents (such as monoclonal antibodies including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing.
- Current enrollment or past participation within the last 30 days before signing of consent in any other clinical study involving an investigational study intervention or any other type of medical research.
- Alanine transaminase (ALT) or aspartate transaminase (AST) >1.5 x upper limit of normal (ULN)
- Total bilirubin >1.5 x ULN (isolated bilirubin >1.5 x ULN is acceptable if total bilirubin is fractionated and direct bilirubin <35%)
- QTcF >450 msec for male participants or >470 msec for female participants
- Positive prestudy drug/alcohol screen
- Positive HIV antibody test
- Clinical laboratory findings outside the normal range and determined by the investigator or medical monitor to be clinically significant.
- Clinically significant abnormalities on screening EEG which may indicate an increased risk of seizure liability.
- Reported sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates participation in the study
- Reported regular use of known drugs of abuse within the past 3 years.
- Presence of any contraindication to venous blood sampling for pharmacokinetic analyses.
- Positive SARS-CoV-2 test or hepatitis panel (including hepatitis B surface antigen [HBsAg] or hepatitis C virus antibody [anti-HCV]), or a positive HIV antibody screen
- Legal incapacity or limited legal capacity
- Participation in a clinical trial within 30 days prior to product administration.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Multiple Ascending Dose, Phase 1, Double-Blind, Study to Investigate the Safety and Pharmacokinetics of NTRX-07 in Healthy Volunteers and Patients With Early Alzheimer's Disease (AD), With an Exploratory Fed-Fasted Assessment
This is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.
- Conditions
- Alzheimer Disease
- Being tested
- NTRX-07, Placebo
- Keywords
- CB2
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NTRX-07Drug
Also called MDA7
Investigational orally administered CB2 agonist
PlaceboDrug
Matched placebo administered orally
| Study group | Role | What they receive |
|---|---|---|
| NTRX-07 Low Dose Normal Volunteers | Experimental | NTRX-07 administered orally once per day for 7 days Receives: Drug: NTRX-07 |
| NTRX-07 Mid Dose Normal Volunteers | Experimental | NTRX-07 administered orally once per day for 7 days Receives: Drug: NTRX-07 |
| NTRX-07 High Dose Normal Volunteers | Experimental | NTRX-07 administered orally once per day for 7 days Receives: Drug: NTRX-07 |
| NTRX-07 High Dose Alzheimer's Participants | Experimental | NTRX-07 administered orally once per day for 7 days Receives: Drug: NTRX-07 |
| Placebo Control | Placebo comparator | Placebo administered orally once per day for 7 days Receives: Drug: Placebo |
| Mid Dose Fed | Experimental | NTRX-07 administered orally once with high fat meal Receives: Drug: NTRX-07 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Treatment-Related Adverse Events
AEs observed and recorded according to MEDRA
Measured: From admission to discharge, up to 2 weeks
Secondary outcomes (3)
Time to Maximum Concentration of NTRX-07 NTRX-07
Pharmacokinetic profile of NTRX-07
Measured: Day 1 and Day 7
Maximum Concentration of NTRX-07 NTRX-07
Pharmacokinetic profile of NTRX-07
Measured: Day 1 and Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC) NTRX-07
Pharmacokinetic profile of NTRX-07
Measured: Day 1 and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2024
- Study start6 Sep 2022
- Primary completion31 May 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- NeuroTherapia, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CRU Early Phase Unit Kistarcsa
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06194552
- Sponsor's protocol ID
- NTRX-C102
- Status last verified
- Nov 2023
- First submitted
- 23 Oct 2023
- Last updated
- 8 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multiple Ascending Dose, Phase 1, Double-Blind, Study to Investigate the Safety and Pharmacokinetics of NTRX-07 in Healthy Volunteers and Patients With Early Alzheimer's Disease (AD), With an Exploratory Fed-Fasted Assessment
- ClinicalTrials.gov ID
- NCT06194552
- Acronym / sponsor ID
- NTRX-C102
- Conditions
- Alzheimer Disease
- Keywords
- CB2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- NeuroTherapia, Inc.Industry (pharma, biotech, devices)
- Collaborators
- CRU Early Phase Unit Kistarcsa
- Study start
- 6 Sep 2022 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 8 Jan 2024 (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 is a Phase 1, Randomized, Placebo-Controlled, Modified Parallel Design Multiple Ascending Dose Study of NTRX 07 to Assess Safety and Tolerability and Pharmacokinetics in Adult Healthy Volunteers and Subjects with MCI or Early AD. In addition, an exploratory study of the effect of a high fat meal was conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| NTRX-07 Low Dose Normal Volunteers | Experimental | Drug: NTRX-07NTRX-07 administered orally once per day for 7 days |
| NTRX-07 Mid Dose Normal Volunteers | Experimental | Drug: NTRX-07NTRX-07 administered orally once per day for 7 days |
| NTRX-07 High Dose Normal Volunteers | Experimental | Drug: NTRX-07NTRX-07 administered orally once per day for 7 days |
| NTRX-07 High Dose Alzheimer's Participants | Experimental | Drug: NTRX-07NTRX-07 administered orally once per day for 7 days |
| Placebo Control | Placebo comparator | Drug: PlaceboPlacebo administered orally once per day for 7 days |
| Mid Dose Fed | Experimental | Drug: NTRX-07NTRX-07 administered orally once with high fat meal |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Participant must be 45 80 years of age inclusive, at the time of signing the informed consent
- Cohorts A-C participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring.
- Cohort D - AD as characterized by the following clinical, cognitive, and functional criteria.
- Cohort D - Previous brain imaging study, such as magnetic resonance imaging (MRI) and/or computed tomography (CT), consistent with a diagnosis of probably AD without any other clinically significant co-morbid pathologies within 12 months prior to the Screening Visit. If there has been a significant change in clinical status suggestive of stroke or other possible central neurological disease with onset between the time of the last MRI or CT and the Screening evaluation, the scan should be repeated during Screening procedures if considered appropriate by the Investigator OR Screening cerebrospinal fluid (CSF) results consistent with the presence of amyloid pathology.
- Cohort D - No active depression and a Geriatric Depression Score of <6.
Key exclusion criteria (26 listed)
- Reported history or presence of clinically significant history of or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrinological, hematological, or neurological disorders capable of significantly altering the absorption, metabolism, or elimination of drugs; constituting a risk when taking the study intervention; or interfering with the interpretation of data. Participants with stable well controlled conditions may be accepted on review with the Investigator and sponsor.
- Reported current or chronic history of clinically significant liver disease. This includes but is not limited to hepatitis virus infections, drug- or alcohol-related liver disease, nonalcoholic steatohepatitis, autoimmune hepatitis, hemochromatosis, Wilson's disease, α-1 antitrypsin deficiency, primary biliary cholangitis, primary sclerosing cholangitis, or any other liver disease considered clinically significant by the investigator.
- Reported hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- Cohort D - Reside in a nursing home or assisted care facility with need for direct continuous medical care and nursing supervision. Participant may reside in such facilities provided continuous direct medical care is not required.
- Cohort D - Unable to provide for self for basic activities of daily living.
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 |
|---|---|---|
| NTRX-07Also: MDA7Investigational orally administered CB2 agonist | Drug | Mid Dose Fed, NTRX-07 High Dose Alzheimer's Participants, NTRX-07 High Dose Normal Volunteers, NTRX-07 Low Dose Normal Volunteers, NTRX-07 Mid Dose Normal Volunteers |
| PlaceboMatched placebo administered orally | Drug | Placebo Control |
Primary outcome
Number of Participants With Treatment-Related Adverse Events
Time frame: From admission to discharge, up to 2 weeks
AEs observed and recorded according to MEDRA
3 secondary outcomes
Time to Maximum Concentration of NTRX-07 NTRX-07
Time frame: Day 1 and Day 7
Maximum Concentration of NTRX-07 NTRX-07
Time frame: Day 1 and Day 7
Area Under the Plasma Concentration Versus Time Curve (AUC) NTRX-07
Time frame: Day 1 and Day 7
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 8 Jan 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NTRX-07 in people with Alzheimer Disease, run by NeuroTherapia, Inc. at 2 sites in 2 countries.
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 16 inclusion and 26 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 8 Jan 2024. 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 United States, Hungary. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Number of Participants With Treatment-Related Adverse Events (time frame: From admission to discharge, up to 2 weeks). 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 8 Jan 2024.