Phase 1 Test-retest Evaluation of [18F]MNI-958 PET
Completed · Phase 1
Conditions studied: Healthy Volunteers, Alzheimer Disease, Progressive Supranuclear Palsy
In brief
The overall goal of this protocol is to evaluate \[18F\]MNI-958 also known as APN-0000455 or PM-PBB3, a tau targeted radiopharmaceutical.
Key facts
- Study ID
- NCT03545789
- Run by
- Invicro
- People needed
- 16
- Starts
- 2018-03-12
- Expected to finish
- 2020-02-06
- Last updated by the study team
- 2020-02-17
Who can join
Age: 18 and older, up to 55. Sex: any. Healthy volunteers: accepted.
You may not qualify if…
- Exclusion Criteria (for All subjects)
- Current or prior history (in the last 12 months) of any alcohol or drug abuse.
- Laboratory tests with clinically significant abnormalities and/or clinically significant unstable medical illness.
- Subject has received an investigational drug or device within 30 days of screening
- Prior participation in other research protocols or clinical care in the last year in addition to the radiation exposure expected from participation in this clinical study, such that radiation exposure exceeds the effective dose of 50 mSv, which would be above the acceptable annual limit established by the US Federal Guidelines.
- Pregnancy, lactating or breastfeeding.
- Evidence of clinically significant gastrointestinal, cardiovascular, hepatic, renal, hematological, neoplastic, endocrine, alternative neurological, immunodeficiency, pulmonary, or other disorder or disease.
- Unsuitable veins for repeated venipuncture.
- MRI exclusion criteria include: Findings that may be responsible for the neurologic status of the patient such as significant evidence of cerebrovascular disease (more than two lacunar infarcts, any territorial infarct >1cm3, or deep white matter abnormality corresponding to an overall Fazekas scale of 3 with at least one confluent hyperintense lesion on the FLAIR sequence that is ≥20 mm in any dimension), infectious disease, space-occupying lesions, normal pressure hydrocephalus or any other abnormalities associated with CNS disease.
- Implants such as implanted cardiac pacemakers or defibrillators, insulin pumps, cochlear implants, metallic ocular foreign body, implanted neural stimulators, CNS aneurysm clips and other medical implants that have not been certified for MRI, or history of claustrophobia in MRI.
- Exclusion criteria for subjects with AD:
- Has received treatment that targeted Aβ or tau within the last 3 months.
- Exclusion criteria for subjects PSP:
- Ongoing treatment with methylphenidate, modafinil, metoclopramide, alpha methyldopa, reserpine, or amphetamine derivative for subjects requiring DaTscan imaging.
- Subjects may take stable doses of bupropion, however this medication must be held for at least 12 hours prior to DaTscan imaging.
Where it is running
- Invicro — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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