Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06… (NCT03876002) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Microglial Activation in ALS With [18F]PBR06 (Peripheral Benzodiazepine Receptor-06) PET
United States23 participantsStarted 2016-06-28
Plain-language summary
The overall goal of this protocol is to evaluate microglial activation in the brain using \[18F\]PBR06 in patients with amyotrophic lateral sclerosis (ALS).
Who can participate
Age range18 Years – 80 Years
SexALL
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Inclusion Criteria (for all subjects):
* Written informed consent must be obtained before any assessment is performed.
* Provide signed and dated written informed consent.
* Female subjects must be documented by medical records or physician's note to be either surgically sterile (by means of hysterectomy, bilateral oophorectomy, or tubal ligation) or post-menopausal for at least 1 year or, if they are of child-bearing potential, must commit to the use of a barrier method of contraception for the study duration,
* Male subjects and their partners of childbearing potential must commit to the use of a barrier method of contraception for the study duration.
* Male subjects must not donate sperm for the study duration.
* Able to lie supine on camera bed for a reasonable period of time.
* Willing and able to cooperate with study procedures.
* Women of child bearing potential must have a negative pregnancy test at screening.
Inclusion criteria specific to healthy volunteer subjects:
* Males and females aged 45-80 years, healthy with no clinically relevant finding on physical examination at screening and upon reporting for the \[18F\]PBR06 imaging sessions.
* No family history of ALS or frontotemporal dementia.
* C-reactive protein level ≤10 mg/dL Inclusion criteria specific to ALS subjects
* Males and females aged 18 to 80 years.
* Sporadic or familial ALS diagnosed as possible, laboratory-supported probable, probable, or definite as defined by the modified El Escorial criteria;
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