Is NCT05395624 recruiting in Jacksonville, FL?

Yes, NCT05395624 is currently recruiting participants at its Jacksonville, FL location. This als clinical trial is actively enrolling qualified participants.

How do I join the als clinical trial in Jacksonville?

To join this clinical trial in Jacksonville, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Jacksonville clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

ALS Clinical Trial in Jacksonville, FL

Who Can Participate

Inclusion Criteria

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 subjects 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 postmenopausal, defined as spontaneous amenorrhea for at least 2 years, with follicle-stimulating hormone (FSH) in the postmenopausal range at screening, based on the local laboratory's defined ranges.

Female subjects of childbearing potential (i.e., ovulating, premenopausal, and not surgically sterile) and all male subjects must agree to practice abstinence from sexual intercourse or use a medically accepted contraceptive regimen (including hormonal contraceptives) during their participation in the study and for 90 days (males) or 6 months (females) after Day 1. Medically accepted contraceptive methods are defined as those with 90% or greater efficacy and are as follows:

Male subjects: condoms or surgical sterilization of subject at least 26 weeks before the Screening Visit (i.e., vasectomy).

Female subjects:

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, subjects must agree to abstain from sperm donation through 90 days after the Day 1 Visit.

Female subjects may not be pregnant, lactating, or breastfeeding.

Female subjects of childbearing potential must have negative result for pregnancy test at Screening and Check-in.

Subjects must have an estimated glomerular filtration rate (eGFR) of \>45 mL/min/1.73m2 at Screening.

C-reactive protein level ≤10 mg/dL.

Subjects must be willing and able to abide by all study requirements and restrictions. Inclusion Criteria Specific to ALS Subjects:

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 investigator.

For ALS subjects, medication changes within 30 days prior to the Screening Visit should be discussed with the Medical Monitor. Inclusion Criteria Specific to AD Subjects

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. Inclusion Criteria Specific to MS Subjects:

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. Inclusion criteria specific to subjects with RRMS:

Diagnosis of RRMS based on 2017 McDonald criteria

If not newly diagnosed, subjects should have at least 1 documented relapse in the last 24 months.

"Active disease" subjects should have at least 1 Gadolinium-enhancing (Gd+) T1-weighted brain or spinal cord lesion at Screening MRI.

"Disease in remission" subjects 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 Inclusion criteria specific to subjects 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 Inclusion Criteria Specific to PD Subjects:

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

Exclusion Criteria

- For All Subjects: Subjects 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 clinically significant drug allergies) or any other condition that, in the opinion of the Investigator, might significantly interfere with the absorption, distribution, metabolism or excretion of study drug or place the subject at an unacceptable risk as a participant in this study

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 aspartate transaminase (AST) and alanine transaminase (ALT) more than 3 times above the upper limit of normal at screening and/or check-in is exclusionary. One retest of an exclusionary laboratory result is allowed at the discretion of the Investigator and with approval from the Medical Monitor.

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 lesions, hydrocephalus or other abnormalities associated with CNS disease not related to ALS, AD, MS or PD

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 Subjects:

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 \[aquaporin-4\] antibodies or anti-MOG antibodies)

Diagnosis of progressive multifocal leukoencephalopathy (PML) Exclusion Criteria Specific to PD Subjects:

Secondary, atypical, or genetic parkinsonism Exclusion Criteria Specific to HV Subjects:

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

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Jacksonville?

Yes, this clinical trial (NCT05395624) has an active research site in Jacksonville, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

ALS Treatment Options in Jacksonville, FL

If you're searching for als treatment options in Jacksonville, FL, this clinical trial (NCT05395624) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Jacksonville research site is actively enrolling participants for this phase 1/2 clinical trial. You'll receive care from experienced als specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all als clinical trials near you to find additional studies recruiting in your area.

ALS Clinical Trial in Jacksonville, FL

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