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Tests treatment safety and results for Amyotrophic Lateral Sclerosis (ALS)
Official title Safety, PK and Biodistribution of 18F-OP-801 in Patients With ALS, AD, MS, PD and Healthy Volunteers
ClinicalTrials.gov ID: NCT05395624
What this study is testing
What is 18F-OP-801?
18F-OP-801 is an investigational medicine, being studied as a potential treatment for amyotrophic lateral sclerosis (als).
Also referred to as 18F Hydroxyl Dendrimer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a Phase 1/2 study to evaluate the safety and tolerability of 18F-OP-801 in subjects with ALS, AD, MS, PD and age-matched HVs. 18F-OP-801 is intended as a biomarker for PET imaging of activated microglia and macrophages in regions of neuroinflammation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80. Healthy volunteers may be eligible.
You may be able to join if
- Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to the conduct of...
- Female people of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or...
- Female people of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male people must agree to practice...
- Male people: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).
- Female people:
You likely can't join if
- For All people: people meeting any of the following criteria will be excluded from this study:
- Body weight \>120 kg
- Evidence of clinically significant or past medical history of hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic...
- History of recurrent kidney or liver malignancy
- Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI
- Inability to lie in a PET/CT or PET/MRI scanner for up to 90 minutes at a time
See the full eligibility criteria
Who can join
- Has the ability to understand and sign the written ICF and local medical privacy authorization forms, which must be obtained prior to the conduct of any study related procedures.
- Female people of non-childbearing potential must be either surgically sterile (hysterectomy, bilateral tubal ligation, salpingectomy, and/or bilateral oophorectomy at least 26 weeks before the Screening Visit) or...
- Female people of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male people must agree to practice abstinence from sexual intercourse or use a medically accepted...
- Male people: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).
- Female people:
- Surgical sterilization at least 26 weeks before the Screening Visit (includes hysterectomy or bilateral tubal ligation, bilateral oophorectomy, or salpingectomy);
- Intrauterine device or diaphragm with spermicide for at least 12 weeks before the Screening Visit; or
- Hormonal contraception (oral, implant, injection, ring, or patch) for at least 12 weeks before the Screening Visit.
- If male, people must agree to abstain from sperm donation through 90 days after the Day 1 Visit.
- Female people may not be pregnant, lactating, or breastfeeding.
- Female people of childbearing potential must have negative result for pregnancy test at Screening and Check-in.
- people must have an estimated glomerular filtration rate (eGFR) of \>45 mL/min/1.73m2 at Screening.
- C-reactive protein level ≤10 mg/dL.
- people must be willing and able to abide by all study requirements and restrictions. Specific to ALS people:
- Adult (Age 18 to 80, inclusive) at the Screening Visit
- Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria.
- Forced vital capacity (FVC) of ≥50%; or if in the opinion of the investigator can lay flat for up to 90 minutes. If FVC has been performed within the past 6 months, this data may be used at the discretion of the...
- For ALS people, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. Specific to AD people
- Adult (Age 40 to 80, inclusive) at the Screening Visit
- Clinical diagnosis of early stage dementia, Alzheimer type, plus positive Aβ and tau PET imaging, cerebrospinal fluid (CSF) and/or plasma biomarkers consistent with 2018 NIA-AA criteria
- MMSE score \>20 at Screening
- AD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. Specific to MS people:
- Adult (Age 18 to 70, inclusive) at the Screening Visit
- MS medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. specific to people with RRMS:
- Diagnosis of RRMS based on 2017 McDonald criteria
- If not newly diagnosed, people should have at least 1 documented relapse in the last 24 months.
- "Active disease" people should have at least 1 Gadolinium-enhancing (Gd+) T1-weighted brain or spinal cord lesion at Screening MRI.
- "Disease in remission" people should have no Gd+ T1-weighted brain or spinal cord lesions at Screening MRI and stable clinical symptoms for at least 3 months prior to Day 1.
- EDSS score between 2.0 and 5.5 inclusive at Screening specific to people with progressive MS:
- Diagnosis of PPMS or SPMS based on 2017 McDonald criteria
- EDSS score between 3.0 and 6.5 inclusive at Screening
- No evidence of relapse in the prior 6 months
- Neurological exam and symptom stability for ≥30 days prior to Day 1
- Documented evidence of disability progression in the past 24 months not temporally related to a relapse Specific to PD people:
- Adult (Age 55 to 80, inclusive) at the Screening Visit
- Diagnosis of definite, idiopathic Parkinson's disease according to UK Parkinson's Society Brain Bank diagnostic criteria
- PD medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. Overall
What rules you out
- For All people: people meeting any of the following criteria will be excluded from this study:
- Body weight \>120 kg
- Evidence of clinically significant or past medical history of hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease (including multiple or...
- History of recurrent kidney or liver malignancy
- Pacemaker or defibrillator or any non-removable metallic foreign objects in the body not compatible with MRI
- Inability to lie in a PET/CT or PET/MRI scanner for up to 90 minutes at a time
- Laboratory results (serum chemistry, hematology, coagulation and urinalysis) outside the normal range at Screening and Check-In and considered clinically significant in the opinion of the Investigator. Any elevation of...
- Resolved acute illness considered clinically significant by the Investigator within 10 days prior to Screening
- History of alcoholism or drug abuse within 2 years prior to Screening. No cannabinoid drug use for at least 10 days prior to Day 1.
- Positive urine drug test, marijuana test or cotinine test at Screening or Check-In
- Any immunizations within the 28 days prior to screening
- Received any other investigational medicinal product within 30 days or 5 half-lives (whichever is longer) prior to Day 1
- Corticosteroid treatment (e.g., prednisone, solumedrol) within 30 days of Baseline
- Treatment with any of the following classes of nonsteroidal anti-inflammatory drugs (NSAIDS): carboxylic acids, enolic acids, cyclooxygenase (COX) II inhibitors within 14 days of Day 1
- Lost or donated \>450 mL of whole blood or blood products within 30 days prior to Screening
- MRI exclusion criteria: findings that may interfere with interpretation of the PET imaging, including but not limited to significant cortical/subcortical cerebrovascular disease, infectious disease, space-occupying...
- CT exclusion criteria include any medical device or metallic implant that may interfere with image acquisition or affect image reconstruction (e.g., CT attenuation correction).
- Investigator has reason to believe that the subject may be unable to fulfill the protocol visit schedule or requirements
- Has any finding that, in the view of the Investigator and Medical Monitor, would compromise the subject's safety in the trial Exclusion Criteria Specific to MS people:
- Clinical signs or laboratory findings suggestive of neuromyelitis optica (NMO) spectrum disorders or myelin oligodendrocyte glycoprotein (MOG)-associated encephalomyelitis (i.e., presence of anti-NMO [aquaporin-4]...
- Diagnosis of progressive multifocal leukoencephalopathy (PML) Exclusion Criteria Specific to PD people:
- Secondary, atypical, or genetic parkinsonism Exclusion Criteria Specific to HV people:
- Clinically relevant finding on physical examination at Screening
- Family history of neurological disease that may confound interpretation of imaging results
- History of any central nervous system disorder or brain trauma that could cause imaging abnormalities in the opinion of the Principal Investigator and Medical Monitor
The study team makes the final eligibility decision.
Where it's taking place
- San Francisco, California, United States
- Stanford, California, United States
- Jacksonville, Florida, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include San Francisco, California, United States; Stanford, California, United States; Jacksonville, Florida, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.