Mild, Moderate, or Severe Alzheimer's DiseasePhase 2NCT06745583
A Phase 2 Study to Assess the Safety of EI-1071 and the Effects of EI-1071 on Neuroinflammation in Alzheimer's Disease Patients
A Phase 2 study testing EI-1071 tablet, oral in people with Mild, Moderate, or Severe Alzheimer's Disease, run by Elixiron Immunotherapeutics Inc. at 2 sites in Taiwan.
Trial summary
An open-label, exploratory, phase II, proof-of concept, clinical study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or severe Alzheimer's disease Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild, Moderate, or Severe Alzheimer's Disease
- What is being tested?
- EI-1071 tablet, oral
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 2 sitesTaiwan
- Study dates
- 16 Dec 2024to 6 May 2026
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must meet all the clinical criteria for mild to severe AD (i.e., probable or possible AD dementia by NIA-AA criteria; must have objective evidence of cognitive impairment at Screening
- Clinical Dementia Rating Scale (CDR)≧0.5
- If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening.
- Adequate hematologic, hepatic, and renal function at the screening visit defined by the following criteria:
- Absolute neutrophil count (ANC) ≥ 1.5 × 10⁹/L
- Hemoglobin [Hgb] > 10 g/dL
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- Platelet count ≥ 100 × 10⁹/L
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 1 × upper limit of normal (ULN)
- Total bilirubin and direct bilirubin ≤ 1.0 × ULN
- Alkaline phosphatase (ALP) ≤ 1.0 × ULN
- Creatinine clearance (CCr) ≥ 60 mL/min
- Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit (female subjects must be surgically confirmed sterile, i.e., had hysterectomy, bilateral oophorectomy, or tubal ligation procedures), post-menopausal for at least 1 year (documented in the medical history), or must commit to use two contraceptive methods during the study.
- Female subject with childbearing potential must be willing to implement adequate, highly effective contraceptive measure during the study period. Effective birth control includes:
- Intrauterine device plus one barrier method
- Oral, implantable, or injectable contraceptives plus one barrier method; or
- Two barrier methods
- Effective barrier methods are male or female condoms, diaphragms, or spermicides (creams or gels that contain a chemical to kill sperm). Women of childbearing potential are those who have not been surgically sterilized or have not been free from menses for ≥ 1 year.
- Male subject who agrees to use an adequate method of contraception during the study period [e.g., barrier contraceptives (male condom)].
- Subjects or his/her legal representative or guardian are willing to sign written informed consent and willing to comply with study requirements.
Who cannot join
- Body weight ≥ 150 kg or body mass index (BMI) ≥ 35 kg/m² at the screening visit.
- Prior use of pexidartinib (Turalio), other chemical entities, or any biologic treatment targeting colony stimulating factor 1 (CSF-1) or the CSF-1 receptor within 3-month of the first dose with EI-1071; previous uses of oral tyrosine kinase inhibitors are allowed (e.g., imatinib or nilotinib).
- AD patients with low binding affinity for tracer TSPO rs6971 SNP polymorphism at screening
- Pregnant, breast feeding or plan to be pregnant women during the study period
- Active tuberculosis (TB), active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) or known active or chronic infection with human immunodeficiency virus (HIV) at screening or in the medical history.
- Any medical or neurological/neurodegenerative condition (including mental deficit, intracranial tumor, glioma or meningioma; head trauma, Lewy body dementia; other disease than AD) that, in the opinion of the Investigator, might be a contributing cause to the participant's cognitive impairment or could lead to discontinuation, lack of compliance, interference with study assessments, or safety concerns
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- Clinically significant, unstable psychiatric illness or have contraindications to brain magnetic resonance imaging (MRI) or PET scans
- Have had a stroke or Transient Ischemic Attack (TIA), unexplained loss of consciousness or relevant brain hemorrhage, bleeding disorder and cerebrovascular abnormalities in the past year based on medical history (with MRI imaging results as confirmation in the medical history) at screening. Subjects with clinically relevant cerebrovascular abnormalities in MRI will be excluded per PI's discretion.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine (including poor-controlled T2DM), neurological, immunodeficiency, pulmonary, or other disorder or disease at the screening visit (such as neurological or cognitive impairment/decline due to substance abuse, vitamin B12 deficiency, abnormal thyroid function, or other underlying condition might contribute to cognitive, functional or behavioral impairment will be excluded) by investigator's judgment at screening; subjects who have to be fed by enteral tube will be excluded.
- History of or ongoing malignancy or carcinoma (either concurrent or within the last year of starting study treatment) that requires therapy (e.g., surgical, chemotherapy, or radiation therapy), except for adequately treated basal or squamous cell carcinoma of the skin, melanoma in-situ, carcinoma in-situ of the cervix or breast
- Currently participating in any other clinical study or have participated in clinical trial within the last 60 days prior to screening; had donated blood (≥ 250 mL) within 30 days at screening.
- Known allergy to EI-1071 or hypersensitivity to any component of the formulation (e.g., hydroxypropyl methylcellulose acetate succinate) or hypersensitivity to any radiochemical tracer or [¹⁸F]FEPPA radiochemical tracer
- Required to use strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) and is anticipated to use these inhibitors or inducers during the study period
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
Taipei Veterans General Hospital
Taipei, 112
Tri-Service General Hospital
Taipei, 11490
About this study
Official title: An Open-label, Exploratory, Phase II, Proof-of Concept, Clinical Study to Assess the Safety and Tolerability of EI-1071 in Patients With Alzheimer's Disease (AD)
An open-label, exploratory, phase II, proof-of concept, clinical study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or severe Alzheimer's disease
Read the detailed description
This is an open-label, phase II, exploratory, proof-of-concept study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or sever Alzheimer's disease (AD). The main goals include:
- to validate mechanism-engagement of EI-1071 by tracing the change of activated microglia in selected brain regions in AD patients using TSPO PET/MRI imaging.
- to assess effects of EI-1071 on changes of inflammatory biomarkers associated with AD progression.
- Being tested
- EI-1071 tablet, oral
- Keywords
- Alzheimer's Disease, Neuroinflammation, Neurodegenerative Disorder, Cognitive Dysfunction
- Medical subject headings
- Lymphoma, Follicular, Alzheimer Disease, Neuroinflammatory Diseases, Neurodegenerative Diseases, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EI-1071 tablet, oralDrug
Dose: 448.2 mg BID for 28 days
| Study group | Role | What they receive |
|---|---|---|
| EI-1071 dose | Experimental | Not described Receives: Drug: EI-1071 tablet, oral |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the change of neuroinflammation in brains of AD patients after dosing with EI-1071 by PET
To characterize the change in neuroinflammation in brain after dosing with EI-1071 in AD patients (the change in neuroinflammation will be analyzed by the differences in [18F]FEPPA tracer signal intensity in brain before and after dosing with EI-1071)
Measured: Baseline, Day 28
Secondary outcomes (3)
To assess the safety and tolerability of EI-1071 in AD patients
To assess the safety and tolerability of EI-1071 in AD patients by the following assessments
- Adverse events (AE)/serious adverse events (SAE) monitoring
- Vital signs and 12-lead electrocardiograms (ECG)
- Physical examination
- Laboratory assessments (biochemistry, hematology, urinalysis, and cell count/protein/glucose in cerebrospinal fluid)
Measured: From Day 1 up to Day 84
To assess the exposure of EI-1071 in plasma in AD patients
Measured: Day 1, Day 14, Day 28
To assess the changes to neurological profile by EI-1071
To assess the changes in neurological profile using questionnaires, including cognitive and functional capacity and potential behavioral or psychological characterization in AD patients after dosing with EI-1071
Measured: baseline, D28, D84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2024
- Study start16 Dec 2024
- Primary completion6 Mar 2026
- Study completion6 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild, Moderate, or Severe Alzheimer's 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elixiron Immunotherapeutics Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06745583
- Sponsor's protocol ID
- EI-1071-202
- Other IDs
- PTC-22-973334
- Status last verified
- Sep 2026
- First submitted
- 12 Dec 2024
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Exploratory, Phase II, Proof-of Concept, Clinical Study to Assess the Safety and Tolerability of EI-1071 in Patients With Alzheimer's Disease (AD)
- ClinicalTrials.gov ID
- NCT06745583
- Acronym / sponsor ID
- EI-1071-202
- Keywords
- Alzheimer's Disease, Neuroinflammation, Neurodegenerative Disorder, Cognitive Dysfunction
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Elixiron Immunotherapeutics Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 6 Mar 2026 (actual)
- Study completion
- 6 May 2026 (actual)
- First posted
- 20 Dec 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.
An open-label, exploratory, phase II, proof-of concept, clinical study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or severe Alzheimer's disease
Detailed description
This is an open-label, phase II, exploratory, proof-of-concept study to assess the safety and tolerability of EI-1071 and the effects of EI-1071 on neuroinflammation in patients with mild, moderate, or sever Alzheimer's disease (AD). The main goals include:
- to validate mechanism-engagement of EI-1071 by tracing the change of activated microglia in selected brain regions in AD patients using TSPO PET/MRI imaging.
- to assess effects of EI-1071 on changes of inflammatory biomarkers associated with AD progression.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EI-1071 dose | Experimental | Drug: EI-1071 tablet, oral |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Must meet all the clinical criteria for mild to severe AD (i.e., probable or possible AD dementia by NIA-AA criteria; must have objective evidence of cognitive impairment at Screening
- Clinical Dementia Rating Scale (CDR)≧0.5
- If using drugs to treat symptoms related to AD, doses must be stable for at least 8 weeks prior to screening.
- Adequate hematologic, hepatic, and renal function at the screening visit defined by the following criteria:
- Female subject with childbearing potential must have a negative serum pregnancy test at the screening visit (female subjects must be surgically confirmed sterile, i.e., had hysterectomy, bilateral oophorectomy, or tubal ligation procedures), post-menopausal for at least 1 year (documented in the medical history), or must commit to use two contraceptive methods during the study.
Key exclusion criteria (13 listed)
- Body weight ≥ 150 kg or body mass index (BMI) ≥ 35 kg/m² at the screening visit.
- Prior use of pexidartinib (Turalio), other chemical entities, or any biologic treatment targeting colony stimulating factor 1 (CSF-1) or the CSF-1 receptor within 3-month of the first dose with EI-1071; previous uses of oral tyrosine kinase inhibitors are allowed (e.g., imatinib or nilotinib).
- AD patients with low binding affinity for tracer TSPO rs6971 SNP polymorphism at screening
- Pregnant, breast feeding or plan to be pregnant women during the study period
- Active tuberculosis (TB), active or chronic infection with hepatitis B virus (HBV) or hepatitis C virus (HCV) or known active or chronic infection with human immunodeficiency virus (HIV) at screening or in the medical history.
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 |
|---|---|---|
| EI-1071 tablet, oralDose: 448.2 mg BID for 28 days | Drug | EI-1071 dose |
Primary outcome
To assess the change of neuroinflammation in brains of AD patients after dosing with EI-1071 by PET
Time frame: Baseline, Day 28
To characterize the change in neuroinflammation in brain after dosing with EI-1071 in AD patients (the change in neuroinflammation will be analyzed by the differences in [18F]FEPPA tracer signal intensity in brain before and after dosing with EI-1071)
3 secondary outcomes
To assess the safety and tolerability of EI-1071 in AD patients
Time frame: From Day 1 up to Day 84
To assess the exposure of EI-1071 in plasma in AD patients
Time frame: Day 1, Day 14, Day 28
To assess the changes to neurological profile by EI-1071
Time frame: baseline, D28, D84
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 23 Sep 2026.
- Individual participant dataSharing planned: No
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing EI-1071 tablet, oral in people with Mild, Moderate, or Severe Alzheimer's Disease, run by Elixiron Immunotherapeutics Inc. at 2 sites in Taiwan.
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 19 inclusion and 13 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 23 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 2 sites in Taiwan. 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. 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?
To assess the change of neuroinflammation in brains of AD patients after dosing with EI-1071 by PET (time frame: Baseline, Day 28). 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 23 Sep 2026.