Status:
TERMINATED
Study of [11C]CPPC to Assess the Safety and Tolerability in Patients With ALS
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
Precision Molecular
Conditions:
Amyotrophic Lateral Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The goal of this study is to evaluate the safety of using the \[5-cyano-N-(4-(4-\[11C\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide\] (\[11C\]CPPC) radiotracer in positron emissi...
Detailed Description
This is a Phase 1 study of safety and tolerability of an investigational radiotracer drug called \[5-cyano-N-(4-(4-\[11C\]Methylpiperazin-1-yl)-2-(Piperidin-1-yl)Phenyl)Furan-2-carboxamide\] (\[11C\]C...
Eligibility Criteria
Inclusion
- Have the ability to understand the requirements of the study, provide written informed consent, understand and provide written authorization for the use and disclosure of Protected Health Information (PHI) \[per Health Insurance Portability and Accountability Act (HIPAA) Privacy Ruling\] and comply with the study procedures.
- Men and women at least 18 years old.
- Women must have a negative serum pregnancy test and practice an acceptable method of contraception or be of non-childbearing potential (post-menopausal for at least 2 years or who have undergone hysterectomy, oophorectomy or surgical sterilization).
- Geographic accessibility to the study center and the ability to travel to the clinic for study visits.
- Presence of a willing and able caregiver.
- Diagnosis of ALS based on examination by the site PI, meeting El Escorial criteria for possible, laboratory-supported probable, probable or definite ALS or be a person without a diagnosis of ALS disorder
- Vital capacity ≥ 50% of predicted normal for age, height and gender measured in the seated position and the ability to lie supine for a period of 1 hour.
- Agrees to the visit schedule as outlined in the informed consent.
- Pre-study labs within normal range, or if abnormal, deemed not clinically significant by the site investigator.
Exclusion
- Weakness due to causes other than ALS.
- Receipt of any investigational drug, device or biologic within 30 days of administration of study compound.
- Use of anti-inflammatory medications, immunosuppressants, or benzodiazepines.
- Any concomitant medical disease or condition limiting the safety to participate including, but not limited to:
- Coagulopathy
- Active infection
- Any condition that the site PI feels may interfere with participation in the study
- Inability to provide informed consent as determined by the site PI.
- Known clinical evidence of frontotemporal dementia
- Inadequate family or caregiver support as determined by the site PI.
- Presence of any of the following conditions:
- Current drug abuse or alcoholism
- Unstable medical conditions
- Unstable psychiatric illness including psychosis and untreated major depression within 90 days of screening
Key Trial Info
Start Date :
September 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2023
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT04749433
Start Date
September 1 2021
End Date
March 30 2023
Last Update
October 8 2024
Active Locations (1)
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1
Johns Hopkins Outpatient Center
Baltimore, Maryland, United States, 21287