Beta Amyloid PET Imaging for Alzheimer Disease With [18F]-Fluselenamyl

Официальное название

Beta Amyloid PET Imaging for Alzheimer Disease: [18F]-Fluselenamyl (Alternative Vehicle) Comparison With [11C]-PIB (FSA-PIB AD)

Обзор

The purpose of this research study is to determine the safety of a radiotracer 18F-Fluselenamyl using positron emission tomography (PET) imaging.

Подробное описание

The investigators will first complete whole-body PET dosimetry studies in healthy adult normal volunteers to calculate the actual radiation dose of each human organ and determine the allowable dose for a human subject when receiving a single dose for a PET scan.

Second, imaging of the brain and neck will be completed in a wide range of ages of healthy adult normal control participants and participants with mild cognitive impairment, both male and females to characterize 18F-Fluselenamyl uptake in the brain, its binding to beta-amyloid plaques, and radiolabeled metabolite will be completed. Amyloid is a protein related to dementia of Alzheimer's disease. 11C-PIB PET imaging and MRI of the brain will also be completed in the same participants and the data will be compared with 18F-Fluselenmayl. 11C-PIB and 18F-Fluselenamyl both bind to beta-amyloid plaques.

Finally, a comparison of the normal control participants to patients with Alzheimer's disease will be completed.

Вмешательства

• Препарат 18F-Fluselenamyl
  Participants will receive a single intravenous bolus injection of 10 mCi ± 20% of the investigational radiotracer 18F-Fluselenamyl and will undergo an 18F-Fluselenamyl PET/CT scan of the head and neck.

Первичные конечные точки

• To evaluate the safety of the new formulation of Fluselenamy PET Imaging in 8 healthy adult normal volunteers. [Срок оценки: Through study completion, an average of 1 year]
• PET imaging of [18F]-Fluselenamyl in healthy normal control participants and participants with mild cognitive impairment. [Срок оценки: Through study completion, an average of 2 years]

Критерии участия

Критерии включения

• Male or Female, any race
• Age ≥ 18 years
• Healthy volunteers or volunteers with Alzheimer's disease

Критерии исключения

• Has hypersensitivity to 18F-Fluselenamyl or any of its excipients ;
• Has hypersensitivity to 11C-PIB or any of its excipients ;
• Incapable of providing written informed consent or lacking a legally authorized representative (LAR) to provide informed consent ;
• Unwilling or unable to undergo PET scans tracer injections ;
• Unwilling or unable to undergo MRI (Aim 2 and Aim 3)
• Any condition that, in the Investigator's opinion, could increase the risk to the participant, limit the participant's ability to tolerate the research procedures, or interfere with the collection/analysis of the data (e.g., renal or liver failure, advanced cancer);
• Women who are currently pregnant or breast-feeding;
• Current or recent (within 12 months prior to screening) participation in research studies involving radioactive agents such that the total research-related radiation dose to the participant in any given year would exceed the limits set forth in the U.S. Code of Federal Regulations (CFR) Title 21 Section 361.1.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения

Случай-контроль

Центры проведения

США · 1 центр

• Washington University School of Medicine — St Louis

Идентификаторы

NCT: NCT06439992 · FSA-PIB AD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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