Alzheimer Disease, Early OnsetPhase 1NCT06750432
PMN310 in Patients With Early Alzheimer's Disease (PRECISE-AD)
A Phase 1 study testing PMN310 in people with Alzheimer Disease, Early Onset, run by ProMis Neurosciences, Inc at 22 sites in United States.
Trial summary
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Alzheimer Disease, Early Onset
- What is being tested?
- PMN310
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 22 sitesUnited States
- Study dates
- 13 Dec 2024to Dec 2026
- Phase
- Phase 1
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient and caregiver provide written informed consent.
- Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator.
- Meets all of the following clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD dementia at Screening:
- National Institute on Aging-Alzheimer's Association criteria for MCI due to AD or mild AD dementia (Stage 3 and 4)
- Global Clinical Dementia Rating (CDR) of 0.5 or 1.0 and memory box score ≥ 0.5 at Screening and Baseline
- MMSE score between ≥ 20 and 30 inclusive at Screening, and
Show all 19Show fewer
- Either a positive amyloid PET scan within 12 months of Screening consistent with AD, or a positive amyloid PET during Screening.
- Body mass index between 18 and 36 kg/m2 inclusive.
- Patients of childbearing potential must meet the following criteria:
- Male and female patients with reproductive potential must be willing to use an approved double barrier contraceptive method (e.g., condom plus intrauterine device, condom plus hormonal contraception, or double barrier device) during and for 120 days after the last dose of study drug
- Females of childbearing potential must have a negative serum pregnancy test during Screening, a negative urine pregnancy test prior to each dose, and not currently be breastfeeding.
- Patients of non-childbearing potential must meet 1 of the following:
- Post-menopausal female (i.e., 12 consecutive months of spontaneous amenorrhea, age > 51 years).
- Surgically sterile (i.e., bilateral oophorectomy or hysterectomy).
- Has a reliable caregiver who agrees to accompany the patient at study visits, accurately report patient's status, provide feedback on functional and safety assessments, and ensure compliance to study requirements.
- Confirmed to have acceptable venous access for blood collections and IV administration of study drug (i.e., PMN310 or placebo).
- Patients taking Food and Drug Administration-approved acetylcholinesterase inhibitors or memantine are allowed as long as the dose has been stable for at least 3 months prior to Screening. Patients taking low-dose (5mg) donepezil only require a stable dose for at least 6 weeks prior to baseline.
- Gradual and progressive memory impairment for >12 months as reported by the patient or informant.
- A positive result on the Lumipulse G p-tau217/β-Amyloid 1-42 Plasma Ratio test during Screening (when available). If results are indeterminate or unavailable, a patient with a plasma p-tau-217 result of ≥0.50 ng/L will be considered eligible.
Who cannot join
- Living in a continuous care or long-term care nursing facility. Patients in outpatient living at home or in an assisted living facility are eligible for the study.
- Medical or neurological condition (other than AD; i.e., Parkinson's disease, Huntington's disease, frontal temporal dementia, dementia with Lewy bodies) judged to be contributing to the patient's cognitive impairment.
- Laboratory and electrocardiogram (ECG) abnormalities:
- QT (QTcF) interval > 450 msec (males) or > 470 msec (females) during Screening
- Alanine aminotransferase ≥ 2 × upper limit of normal (ULN); aspartate aminotransferase ≥ 2 × ULN; total bilirubin ≥1.5 × ULN during Screening
- Creatinine clearance < 30mL/min during Screening.
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- In the opinion of the Investigator, any clinically significant current or relevant history of physical or psychiatric illness (including suicidal risk, ideation, behavior, or suicide attempts), any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Clinically significant recurrent disease or unstable disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments, such as (but not limited to) the following:
- History of unstable angina, myocardial infarction, chronic heart failure, or clinically significant conduction abnormalities within 1 year prior to Screening
- Indication of clinically significant impairment of renal or liver function, including hepatitis B surface antigen, or hepatitis C virus antibody at Screening
- Poorly managed hypertension (systolic > 160 mmHg and/or diastolic > 95 mmHg) or hypotension (systolic < 90 mmHg and/or diastolic < 60 mmHg). Two repeated assessments during Screening are allowed
- Known uncontrolled diabetes defined by hemoglobin A1c > 7.5 or insulin dependent diabetes.
- Experienced a significant systemic illness, as judged by the Investigator, within 30 days of the first dose of study drug.
- Seizure in the 3 years prior to Screening.
- History of a clinically significant medical condition that would interfere with the patient's ability to comply with study instructions, would place the patient at increased risk, or might confound the interpretation of the study results.
- History of prior malignancy (except adequately treated non-melanoma skin cancer or carcinoma in situ of the cervix).
- Brain MRI with evidence of any of the following findings at Screening: >4 microhemorrhages; > 1 lobar microhemorrhage, area of superficial siderosis; subarachnoid hemorrhage; any other hemorrhage > 10 mm; > 2 lacunar infarcts or cortical infarct; subjects with severe perivascular spaces or with white matter hyperintensities in a multisort pattern will require PI review prior to inclusion.
- History of stroke or transient ischemic attack within 12 months prior to Screening.
- Contraindication to PET or brain MRI.
- Negative PET scan with any amyloid-targeting ligand within 12 months of Screening or during Screening.
- Pregnant or breastfeeding.
- History of alcohol abuse and/or other substance abuse within 12 months prior to dosing with study drug.
- Positive test for illicit drugs of abuse at Screening.
- Documented history of human immunodeficiency virus antibody.
- Coronavirus disease 2019 (COVID-19) infection within 2 weeks of Screening or ongoing symptoms of COVID-19 at Screening.
- Currently receiving an anti-amyloid treatment, either marketed (lecanemab, donanemab) or investigational or has received anti amyloid therapy within 9 months prior to Screening. In the case of investigational treatment, those known to have received placebo will not be excluded.
- Contraindication to undergoing lumbar puncture (LP) including: sensitivity to local anesthetic, international normalized ratio (INR) > 1.4 or other coagulopathy, platelet cell count of < 120,000/µL, infection at the desired LP site, current use of anti-coagulant medication except for low dose aspirin, degenerative arthritis, spinal scoliosis, back surgery, suspected increased intracranial pressure on history or neurologic exam, non-communicating hydrocephalus or intracranial mass, or prior history of spinal mass or trauma and/or other known clinically significant spinal abnormalities.
- Donated blood or blood products (e.g., plasma, platelets) within 56 days prior to first dose of study drug.
- Received an investigational active agent (e.g., not placebo) within the last 30 days or 5 half-lives, whichever is longer (if known).
- Known history of severe allergic reaction or hypersensitivity to any components of the PMN310 infusion.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
United States22 sites
Alzheimer's Disease Research Center
Albany, New York, 12208
JEM Research Institute
Atlantis, Florida, 33462
Columbus Memory Center, LLC
Columbus, Georgia, 31909
Kerwin Medical Center
Dallas, Texas, 75231
CenExel iResearch, LLC
Decatur, Georgia, 30030
Quantum Laboratories
Deerfield Beach, Florida, 33442
Brain Matters Research
Delray Beach, Florida, 33445
Irvine Center for Clinical Research
Irvine, California, 92614
Healthy Brain Research
Long Beach, California, 90804
Flourish Research
Matthews, North Carolina, 28105
Finlay Medical Research
Miami, Florida, 33126
Gonzalez MD and Aswad MD Health Services, Optimus U Corp
Miami, Florida, 33135
Neuro Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
Renstar Medical Research
Ocala, Florida, 34470
Charter Research
Orlando, Florida, 32803
Headlands Eastern MA LLC
Plymouth, Massachusetts, 02360
Keystone Clinical Studies, LLC
Plymouth Meeting, Pennsylvania, 19462
Alzheimer's Research and Treatment Center
Stuart, Florida, 34997
Charter Research
The Villages, Florida, 32162
Advanced Memory Research Institute of NJ
Toms River, New Jersey, 08755
Alzheimer's Research and Treatment Center
Wellington, Florida, 33414
Conquest Research, LLC
Winter Park, Florida, 32789
About this study
Official title: A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients With Early Alzheimer's Disease
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.
Read the detailed description
This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo.
Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.
- Conditions
- Alzheimer Disease, Early Onset
- Being tested
- PMN310, Placebo
- Medical subject headings
- Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PMN310Drug
A humanized immunoglobulin G1 (IgG1) monoclonal antibody
PlaceboDrug
0.9% NaCl 100 mL
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1 PMN310 350 mg or placebo | Experimental | PMN310 350 mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo |
| Cohort 2 PMN310 700 mg or placebo | Experimental | PMN310 700 mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo |
| Cohort 3 PMN310 1400 mg or placebo | Experimental | PMN310 1400 mg or placebo administered as a 60-minute infusion. Receives: Drug: PMN310; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Number and severity of adverse events
Measured: Up to Day 337
Biomarker response to PMN310 following repeat intravenous infusions of PMN310
Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310
Measured: Up to Day 337
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Percent of patients with symptomatic and/or non symptomatic amyloid-related imaging abnormalities
Measured: Up to Day 337
Secondary outcomes (23)
Pk profile of PMN310 with repeat dosing
Serum PK parameter area under the curve to the end of the dosing period (AUCtau)
Measured: Up to Day 337
Assessment of the immunogenicity of PMN310 following repeat intravenous infusions
Immunogenicity of PMN310 - anti-drug antibodies (ADAs) in serum
Measured: Up to Day 309
Assessment of biomarker response to PMN310
Mean change from baseline for amyloid PET
Measured: Up to Day 337
Assessment of cortical and hippocampal volume
Mean change from Baseline in cortical and hippocampal volume
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on CDR-SB
Mean change from Baseline in Clinical Dementia Rating Scale-Sum of Boxes (CDR-SB)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter concentration 4 weeks post-dose (C4W)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter maximum observed concentration (Cmax)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter trough concentration (Ctrough)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter time to reach maximum observed concentration (Tmax)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Concentration of PMN310 in CSF at selected timepoints
Measured: Up to Day 337
Assessment of biomarker response to PMN310
Mean change from baseline for imaging
Measured: Up to Day 337
Assessment of biomarker response to PMN310
Mean change from baseline for plasma biomarkers
Measured: Up to Day 337
Assessment of biomarker response to PMN310
Mean change from baseline for CSF biomarkers
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on ADAS-Cog 14
Mean change from Baseline in Alzheimer's Disease Assessment Scale-Cognition 14 item (ADAS-Cog 14)
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on ADCS-ADL
Mean change from Baseline in Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL)
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on iADRS
Mean change from Baseline in Integrated Alzheimer's Disease Rating Score (iADRS)
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on CGI Scale
Mean change from Baseline in Clinical Global Impressions (CGI) Scale
Measured: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on MMSE
Mean change from Baseline in Mini-Mental State Examination (MMSE)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter steady state concentration (Css)
Measured: Up to Day 337
Pk profile of PMN310 with repeat dosing
Serum PK parameter terminal half-life (t1/2)
Measured: Up to Day 337
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Correlation between changes from baseline of CSF biomarkers and amyloid PET with clinical outcomes
Measured: Up to Day 337
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Correlation between changes from baseline of blood-based biomarkers
Measured: Up to Day 309 or early termination
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Path analysis of the proportion of treatment effect on clinical outcomes explained by changes in biomarkers
Measured: Up to Day 337
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start13 Dec 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer Disease, Early OnsetStudies 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
- Sequential
- Model description
- There will be 3 sequential escalating dose cohort groups. Dose groups are 350 mg, 700 mg, and 1400 mg administered as a single 60-minute infusion.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProMis Neurosciences, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06750432
- Sponsor's protocol ID
- PMN310-102
- Status last verified
- Jul 2026
- First submitted
- 16 Dec 2024
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of PMN310 in Patients With Early Alzheimer's Disease
- ClinicalTrials.gov ID
- NCT06750432
- Acronym / sponsor ID
- PMN310-102
- Conditions
- Alzheimer Disease, Early Onset
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 144 participants (actual)
- Lead sponsor
- ProMis Neurosciences, IncIndustry (pharma, biotech, devices)
- Study start
- 13 Dec 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 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.
This Phase 1b study aims to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of multiple IV infusions of PMN310 in patients with early Alzheimer's disease.
Detailed description
This study is a Phase 1b, randomized, double-blind, placebo controlled, multi-ascending dose study of repeat doses of PMN310 to evaluate the safety, tolerability, PK, PD, and preliminary efficacy of multiple intravenous infusions of PMN310 in patients with early Alzheimer's disease. This study will evaluate 3 dose levels (350 mg, 700 mg, and 1400 mg are planned). Patients will be randomly assigned 3:1, PMN310: placebo.
Each patient will receive PMN310 or placebo once every 28 days for a total of 12 infusions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- There will be 3 sequential escalating dose cohort groups. Dose groups are 350 mg, 700 mg, and 1400 mg administered as a single 60-minute infusion.
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 PMN310 350 mg or placebo | Experimental | Drug: PMN310, Drug: PlaceboPMN310 350 mg or placebo administered as a 60-minute infusion. |
| Cohort 2 PMN310 700 mg or placebo | Experimental | Drug: PMN310, Drug: PlaceboPMN310 700 mg or placebo administered as a 60-minute infusion. |
| Cohort 3 PMN310 1400 mg or placebo | Experimental | Drug: PMN310, Drug: PlaceboPMN310 1400 mg or placebo administered as a 60-minute infusion. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Patient and caregiver provide written informed consent.
- Ambulatory male or female ≥ 50 years of age with adequate visual and auditory abilities to perform the cognitive and functional assessments in the opinion of the Investigator.
- Meets all of the following clinical criteria for mild cognitive impairment (MCI) due to AD or mild AD dementia at Screening:
- Body mass index between 18 and 36 kg/m2 inclusive.
- Patients of childbearing potential must meet the following criteria:
Key exclusion criteria (30 listed)
- Living in a continuous care or long-term care nursing facility. Patients in outpatient living at home or in an assisted living facility are eligible for the study.
- Medical or neurological condition (other than AD; i.e., Parkinson's disease, Huntington's disease, frontal temporal dementia, dementia with Lewy bodies) judged to be contributing to the patient's cognitive impairment.
- Laboratory and electrocardiogram (ECG) abnormalities:
- In the opinion of the Investigator, any clinically significant current or relevant history of physical or psychiatric illness (including suicidal risk, ideation, behavior, or suicide attempts), any medical disorder that may require treatment or make the patient unlikely to fully complete the study, or any condition that presents undue risk from the investigational product or procedures.
- Clinically significant recurrent disease or unstable disease that could affect the action, absorption, or disposition of the investigational product, or could affect clinical or laboratory assessments, such as (but not limited to) the following:
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 |
|---|---|---|
| PMN310A humanized immunoglobulin G1 (IgG1) monoclonal antibody | Drug | Cohort 1 PMN310 350 mg or placebo, Cohort 2 PMN310 700 mg or placebo, Cohort 3 PMN310 1400 mg or placebo |
| Placebo0.9% NaCl 100 mL | Drug | Cohort 1 PMN310 350 mg or placebo, Cohort 2 PMN310 700 mg or placebo, Cohort 3 PMN310 1400 mg or placebo |
Primary outcome
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Time frame: Up to Day 337
Number and severity of adverse events
Biomarker response to PMN310 following repeat intravenous infusions of PMN310
Time frame: Up to Day 337
Mean change in plasma p-tau217 in response to repeat intravenous infusions of PMN310
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310
Time frame: Up to Day 337
Percent of patients with symptomatic and/or non symptomatic amyloid-related imaging abnormalities
23 secondary outcomes
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Assessment of the immunogenicity of PMN310 following repeat intravenous infusions
Time frame: Up to Day 309
Assessment of biomarker response to PMN310
Time frame: Up to Day 337
Assessment of cortical and hippocampal volume
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on CDR-SB
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Assessment of biomarker response to PMN310
Time frame: Up to Day 337
Assessment of biomarker response to PMN310
Time frame: Up to Day 337
Assessment of biomarker response to PMN310
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on ADAS-Cog 14
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on ADCS-ADL
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on iADRS
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on CGI Scale
Time frame: Up to Day 337
Preliminary efficacy of repeat doses of PMN310 on MMSE
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Pk profile of PMN310 with repeat dosing
Time frame: Up to Day 337
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Time frame: Up to Day 337
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Time frame: Up to Day 309 or early termination
Assessment of the strength of the relationship between biomarker response and response on clinical outcomes following repeat intravenous infusions of PMN310
Time frame: Up to Day 337
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 13 Jul 2026.
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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.
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PMN310 in people with Alzheimer Disease, Early Onset, run by ProMis Neurosciences, Inc at 22 sites 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 19 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites 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. 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?
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?
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?
Safety and tolerability of PMN310 following repeat intravenous infusions of PMN310 (time frame: Up to Day 337). The study lists 3 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 13 Jul 2026.