Conditions: Alzheimer's Disease
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 19
Healthy volunteers: yes

Brief summary:
This study will estimate the radiochemical and radiation safety and assess the efficacy of \[18F\]MK-3328, a novel positron emission tomography (PET) tracer. The study safety hypotheses will test whether \[18F\]MK-3328 is sufficiently safe and well-tolerated, based on an assessment of clinical and laboratory evaluations and adverse experiences in healthy participants, including healthy elderly (HE) participants, and Alzheimer's disease (AD) participants, to permit continued investigation. The study efficacy hypothesis will test whether \[18F\]MK-3328 can discriminate between AD participants and cognitively normal elderly control participants based on tracer volume of distribution, or one of its surrogates, in brain posterior cingulate gyrus.

Detailed description:

Arms:
arm 1: Healthy participants will receive a single intravenous (IV) dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part I of the study arm 2: HE and AD participants will receive a single IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part II of the study arm 3: HE and AD participants will receive two separate IV doses of \~150 megabecquerel (MBq) \[18F\]MK-3328 in Part III of the study

Interventions: intervention 1: [18F]MK-3328
Intervention descriptions: intervention 1: IV dose of \~150 megabecquerel (MBq) \[18F\]MK-3328

Protocol document: