Clinical trial NCT00954538: Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)
Official title: A Three Part Study to Evaluate the Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK-3328, a Radiotracer for Use in Positron Emission Tomography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Alzheimer's Disease
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2009-08-07
Enrollment: 19
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: Inclusion Criteria:

Part I:

* Participant is male or female of non-reproductive potential between 50 and 65 years old.
* Participant is less than 6'5" tall
* Participant is in good health
* Participant has been a non-smoker for at least 10 years

Parts II and III:

* Male or female of non-reproductive potential at least 55 years of age
* Participant is cognitively normal (HE participants), or has probable mild-to moderate AD (AD participants)
* Participant is willing to have an arterial catheter placed in the radial artery (Part II only)

Exclusion Criteria:

Part I:

* Participant has a history of stroke, seizures, or neurological disorder
* Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable

Parts II and III:

* Participant has a history or current evidence of any neurological or neurodegenerative disorder other than AD that is associated with altered cognition
* Participant has or has a history of any disease or condition, or takes any medication that would interfere with assessment of the tracer or make participation unsafe or unduly uncomfortable
* Participant is living in a nursing home or skilled nursing facility

Primary outcomes:
measure: Number of Participants With an Adverse Event (AE)
timeFrame: Up to 14 days after last dose
measure: Number of Participants Who Discontinued Study Due to an AE
timeFrame: Up to 14 days after last dose
measure: Effective Dose of [18F]MK-3328
timeFrame: Up to approximately 6 hours post dose
measure: Organ Effective Dose of [18F]MK-3328
timeFrame: Up to approximately 6 hours post dose
measure: Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants
timeFrame: 60-90 minutes post dose
measure: Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants
timeFrame: 60-90 minutes after second dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: