Alzheimer DiseasePhase 1/22-HOBANCT06432166
2-Hydroxybenzylamine (2-HOBA) Study in Early Alzheimer's Patients
A Phase 1/2 study testing 2-hydroxybenzylamine acetate in people with Alzheimer Disease and Mild Cognitive Impairment, run by MTI Biotech Inc at 1 site in United States.
Trial summary
Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Alzheimer Disease, Mild Cognitive Impairment
- What is being tested?
- 2-hydroxybenzylamine acetate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Jun 2029
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
- MCI due to AD:
- Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
- Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
- Mini-Mental State Exam31 score between 24 and 30, inclusive
- Clinical Dementia Rating (CDR)32 Global = 0.5. Memory Box score must be at least 0.5
- Mild AD:
Show all 29Show fewer
- Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
- MCI or Mild dementia of the Alzheimer's type according to the NIA-AA 2018 criteria.
- CDR global score of 0.5 and CDR domain score of 0.5 or more in at least one of the three instrumental activities of daily living categories (personal care, home \& hobbies, community affairs) Or CDR global score of 1.0
- MMSE ≥20
- Additional Inclusion Criteria for Both Diagnoses:
- Age 55-85 (inclusive)
- Abnormal memory function documented by scoring within the education adjusted ranges on the Logical Memory II subscale (Delayed Paragraph Recall) from the Wechsler
- Memory Scale - Revised:
- Less than or equal to 11 for 16 or more years of education
- Less than or equal to 9 for 8 - 15 years of education
- Less than or equal to 6 for 0 - 7 years of education
- Amyloid positivity established using the C2N Precivity2 Plasma test (Aβ42/40 plus p tau217/np-tau217. (This test uses a statistical algorithm to integrate a patient's Aβ42/40 Ratio and p-Tau217 Ratio to calculate the Amyloid Probability Score 2 (APS2) and determines whether a patient is positive or negative for brain amyloid deposition based on a binary cutoff value).
- Stable permitted medications for 4 weeks or longer as specified in Section 4.6.3, including:
- Memantine and cholinesterase inhibitors are allowable if stable for 12 weeks prior to screen.
- Geriatric Depression Scale33 score of less than or equal to 14.
- Study Partner is available who has frequent contact with the participant (e.g., an average of 10 hours per week or more) and can accompany the participant to most visits to answer questions about the participant.
- Adequate visual and auditory acuity to allow neuropsychological testing.
- Good general health with no additional diseases/disorders expected to interfere with the study.
- For women: participant is not pregnant, lactating, or of childbearing potential (i.e., women must be two years post-menopausal or surgically sterile).
- For men: male participants with female partners of childbearing potential must use an effective method of contraception from dosing on Day 1 until 1 month after the lastadministration of study medication and agreed not to donate sperm until 1 month after the last administration of study medication.
- Completed six grades of education or has a good work history.
- Must speak English fluently.
- Provide written informed consent. Participants must have the capacity to consent.
Who cannot join
- Any other significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 2. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation, or behavioral problems within 3 months, which could lead to difficulty complying with the protocol. 3. History of schizophrenia (DSM V criteria). 4. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria). 5. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal (defined by eGFR score <60 mL/min/1.73 m²), hepatic impairment, endocrine, or other systemic disease that, in the opinion of the Investigator, may put the participant at risk because of participation in the study, influence the results, or affect the participant's ability to participate in the study.
- Participants with moderate or severe hepatic impairment, defined as Child-Pugh Class B or C, are excluded. 6. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment. 7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study.
- 8. Clinically significant abnormalities in screening laboratories or ECG. 9. Residence in a skilled nursing facility. 10. Use of any excluded medication as described in Section 4.6.2, including:
- Use centrally acting anti-cholinergic drugs.
- Use of any investigational drugs within 4 weeks or 5 half-lives, whichever is longer, prior to screening. 11. A current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening. 12. Contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker. 13. Participants whom the Site PI deems to be otherwise ineligible. 14. Current use of monoamine oxidase inhibitors (MAOIs) or use within 14 days (or 5 half-lives, whichever is longer) prior to screening, This includes non-selective MAOIs (phenelzine, tranylcypromine, isocarboxazid), MAO-B inhibitors (selegiline, rasagiline, safinamide), reversible MAO-A inhibitors (moclobemide), and other agents with MAOI A inhibitory activity (linezolid, methylene blue at doses >1 mg/kg). This exclusion is required because 2-HOBA has demonstrated MAO-A inhibitory activity in vitro.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Center for Cognitive Medicine, Vanderbilt University Medical Center
Nashville, Tennessee, 37212
Meagan Adams, MSPM, PMP, (615) 421-4352, meagan.adams@vumc.org
Patricia Andrews, M.D.
About this study
Official title: 2-Hydroxybenzylamine (2-HOBA) Phase 1b/2a Proof-of Concept, Dose-Finding, Biomarker Study in Early Alzheimer's Patients
Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250 mg BID, 250 and 500 mg 2-HOBA acetate TID or placebo for 12 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L.
Read the detailed description
This is a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250 mg BID, 250 and 500 mg 2-HOBA acetate TID or placebo for 12 weeks. Blood and CSF will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the study (allowing for up to 25% dropout) for the 12-week study.
The primary aims of this project are to 1) Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain. Investigators hypothesize that 12 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship. 2) Evaluate whether 2-HOBA is safe for extended use in patients with early AD. Investigators hypothesize that 2-HOBA will be safe and well tolerated through 12 weeks of use. Tolerability will be assessed by monitoring symptoms, adverse events, vital signs, ECG, and safety labs during the study.
The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers, brain inflammation, disease severity, and cognitive performance.
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Being tested
- 2-hydroxybenzylamine acetate, Placebo
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease
- Medical subject headings
- Alzheimer Disease, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2-hydroxybenzylamine acetateDrug
Also called 2-HOBA
2-hydroxybenzylamine acetate (2-HOBA) is taken daily for 12 weeks
PlaceboOther
Placebo taken three times per day for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo treatment TID for 12 weeks. Receives: Other: Placebo |
| 250 mg 2-HOBA acetate BID | Active comparator | 250 mg of 2-hydroxybenzylamine (2-HOBA) acetate BID for 12 weeks. Receives: Drug: 2-hydroxybenzylamine acetate |
| 250 mg 2-HOBA acetate TID | Active comparator | 250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks. Receives: Drug: 2-hydroxybenzylamine acetate |
| 500 mg 2-HOBA acetate | Active comparator | 500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks. Receives: Drug: 2-hydroxybenzylamine acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety/Tolerability (adverse events)
Rates of adverse events will be compared between active and placebo arms and presented as summary statistics.
Measured: Baseline to week 12
Change in dicarbonyl protein adducts
Change in CSF levels of the dilysyl-malondialdehyde crosslink and the lysyl-levuglandin adduct of CSF proteins in a dose-responsive relationship
Measured: Baseline to week 12
Secondary outcomes (6)
Compliance
Treatment compliance will be assessed through pill counts at Week 8 and 16
Measured: Baseline to week 12
Measurement of biomarker, p-Tau181
Change in phosphorylated-Tau-181 levels in CSF and plasma:
Measured: Baseline to week 12
Measurement biomarker, human cartilage glycoprotein 39 (YKL-4)
Change in plasma concentration of human cartilage glycoprotein 39 (YKL-4)
Measured: Baseline to week 12
Measurment of biomarker, neurofilaments light chain protein (NF-L)
Change in the concentration of neurofilaments light chain protein (NF-L) in CSF and plasma
Measured: Baseline to week 12
Measurement of biomarker, F2-Isoprostanes
Change in concentration F2-Isoprostanes in plasma and urine:
Measured: Baseline to week 12
Measurement of biomarker, 8-hydroxy-2'-deoxyguanosine
Change in concentration of 8-hydroxy-2'-deoxyguanosine in plasma
Measured: Baseline to week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2024
- Study start1 Sep 2026 (estimated)
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Jun 2029 (estimated)
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MTI Biotech Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Sponsor
- Investigators
- Patricia Andrews, M.D., Principal investigator, Vanderbilt University Medical CenterJohn A. Rathmacher, Ph.D., Principal investigator, MTI Biotech IncPaul A. Newhouse, M.D., Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06432166
- Sponsor's protocol ID
- MTI2024-CS01
- Other IDs
- RC-201910-2019696, IRB 231544
- Acronym
- 2-HOBA
- Status last verified
- Sep 2026
- First submitted
- 14 May 2024
- Last updated
- 24 Sep 2026
- 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 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 2-Hydroxybenzylamine (2-HOBA) Phase 1b/2a Proof-of Concept, Dose-Finding, Biomarker Study in Early Alzheimer's Patients
- ClinicalTrials.gov ID
- NCT06432166
- Acronym / sponsor ID
- 2-HOBA / MTI2024-CS01
- Conditions
- Alzheimer Disease, Mild Cognitive Impairment
- Keywords
- Mild Cognitive Impairment, Alzheimer Disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- MTI Biotech IncIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 1 Sep 2026 (estimated)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Jun 2029 (estimated)
- First posted
- 29 May 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.
Investigators propose a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250 mg BID, 250 and 500 mg 2-HOBA acetate TID or placebo for 12 weeks. Blood and cerebral spinal fluid (CSF) will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L.
Detailed description
This is a phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study to evaluate the safety, tolerability, and biomarker activity of 2-HOBA in 48 MCI/AD participants. Participants will be randomized 1:1:1:1 to receive 250 mg BID, 250 and 500 mg 2-HOBA acetate TID or placebo for 12 weeks. Blood and CSF will be collected to measure markers of protein modification by dicarbonyls (IsoLGs- \& MDA), pTau-181, YKL-40, and NF-L. Investigators anticipate screening 120 subjects to randomize up to 60 subjects with the goal of 48 patients completing the study (allowing for up to 25% dropout) for the 12-week study.
The primary aims of this project are to 1) Provide proof-of-concept that 2-HOBA protects proteins from covalent modification by inhibiting lysine-reacting dicarbonyls in the human brain. Investigators hypothesize that 12 weeks of 2-HOBA treatment will significantly reduce CSF levels of the dilysyl-MDA and IsoLG adduct of CSF proteins in a dose-responsive relationship. 2) Evaluate whether 2-HOBA is safe for extended use in patients with early AD. Investigators hypothesize that 2-HOBA will be safe and well tolerated through 12 weeks of use. Tolerability will be assessed by monitoring symptoms, adverse events, vital signs, ECG, and safety labs during the study.
The secondary aims are to evaluate the effect of 2-HOBA treatment on AD biomarkers, brain inflammation, disease severity, and cognitive performance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- A phase 1b/2a, randomized, double-blind, placebo-controlled, parallel group dose finding and biomarker study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Other: PlaceboPlacebo treatment TID for 12 weeks. |
| 250 mg 2-HOBA acetate BID | Active comparator | Drug: 2-hydroxybenzylamine acetate250 mg of 2-hydroxybenzylamine (2-HOBA) acetate BID for 12 weeks. |
| 250 mg 2-HOBA acetate TID | Active comparator | Drug: 2-hydroxybenzylamine acetate250 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks. |
| 500 mg 2-HOBA acetate | Active comparator | Drug: 2-hydroxybenzylamine acetate500 mg of 2-hydroxybenzylamine (2-HOBA) acetate TID for 12 weeks. |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (29 listed)
- Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
- Participant must have a subjective memory concern as reported by participant, study partner, or clinician.
- Mini-Mental State Exam31 score between 24 and 30, inclusive
- Clinical Dementia Rating (CDR)32 Global = 0.5. Memory Box score must be at least 0.5
- Male or female, aged 55-85 years (both inclusive) at the time of signing informed consent.
Key exclusion criteria (5 listed)
- Any other significant neurologic disease including Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, multiple sclerosis, or history of significant head trauma followed by persistent neurologic deficits or known structural brain abnormalities. 2. Major depression, bipolar disorder as described in DSM-V within the past 1 year or psychotic features, agitation, or behavioral problems within 3 months, which could lead to difficulty complying with the protocol. 3. History of schizophrenia (DSM V criteria). 4. History of alcohol or substance abuse or dependence within the past 2 years (DSM V criteria). 5. Clinically significant or unstable medical condition, including uncontrolled hypertension, uncontrolled diabetes, or significant cardiac, pulmonary, renal (defined by eGFR score <60 mL/min/1.73 m²), hepatic impairment, endocrine, or other systemic disease that, in the opinion of the Investigator, may put the participant at risk because of participation in the study, influence the results, or affect the participant's ability to participate in the study.
- Participants with moderate or severe hepatic impairment, defined as Child-Pugh Class B or C, are excluded. 6. Has had a history within the last 5 years of a primary or recurrent malignant disease with the exception of non-melanoma skin cancers, resected cutaneous squamous cell carcinoma in situ, basal cell carcinoma, cervical carcinoma in situ, or in situ prostate cancer with normal prostate-specific antigen post-treatment. 7. Clinically significant abnormalities in B12 or TFTs that might interfere with the study.
- 8. Clinically significant abnormalities in screening laboratories or ECG. 9. Residence in a skilled nursing facility. 10. Use of any excluded medication as described in Section 4.6.2, including:
- Use centrally acting anti-cholinergic drugs.
- Use of any investigational drugs within 4 weeks or 5 half-lives, whichever is longer, prior to screening. 11. A current blood clotting or bleeding disorder, or significantly abnormal PT or PTT at screening. 12. Contraindications for MRI studies, including claustrophobia, the presence of metal (ferromagnetic) implants, or cardiac pacemaker. 13. Participants whom the Site PI deems to be otherwise ineligible. 14. Current use of monoamine oxidase inhibitors (MAOIs) or use within 14 days (or 5 half-lives, whichever is longer) prior to screening, This includes non-selective MAOIs (phenelzine, tranylcypromine, isocarboxazid), MAO-B inhibitors (selegiline, rasagiline, safinamide), reversible MAO-A inhibitors (moclobemide), and other agents with MAOI A inhibitory activity (linezolid, methylene blue at doses >1 mg/kg). This exclusion is required because 2-HOBA has demonstrated MAO-A inhibitory activity in vitro.
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 |
|---|---|---|
| 2-hydroxybenzylamine acetateAlso: 2-HOBA2-hydroxybenzylamine acetate (2-HOBA) is taken daily for 12 weeks | Drug | 250 mg 2-HOBA acetate BID, 250 mg 2-HOBA acetate TID, 500 mg 2-HOBA acetate |
| PlaceboPlacebo taken three times per day for 12 weeks. | Other | Placebo |
Primary outcome
Safety/Tolerability (adverse events)
Time frame: Baseline to week 12
Rates of adverse events will be compared between active and placebo arms and presented as summary statistics.
Change in dicarbonyl protein adducts
Time frame: Baseline to week 12
Change in CSF levels of the dilysyl-malondialdehyde crosslink and the lysyl-levuglandin adduct of CSF proteins in a dose-responsive relationship
6 secondary outcomes
Compliance
Time frame: Baseline to week 12
Measurement of biomarker, p-Tau181
Time frame: Baseline to week 12
Measurement biomarker, human cartilage glycoprotein 39 (YKL-4)
Time frame: Baseline to week 12
Measurment of biomarker, neurofilaments light chain protein (NF-L)
Time frame: Baseline to week 12
Measurement of biomarker, F2-Isoprostanes
Time frame: Baseline to week 12
Measurement of biomarker, 8-hydroxy-2'-deoxyguanosine
Time frame: Baseline to week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2026.
- 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.
Patricia Andrews, M.D. principal investigator
Vanderbilt University Medical Center
John A. Rathmacher, Ph.D. principal investigator
MTI Biotech Inc
Paul A. Newhouse, M.D. study chair
Vanderbilt University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing 2-hydroxybenzylamine acetate in people with Alzheimer Disease and Mild Cognitive Impairment, run by MTI Biotech Inc at 1 site in United States.
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 29 inclusion and 5 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: opening soon, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact John A. Rathmacher, Ph.D. (515-296-9916, rathmacher@mtibiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety/Tolerability (adverse events) (time frame: Baseline to week 12). The study lists 2 primary outcomes in all. 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 24 Sep 2026.