Status:
COMPLETED
Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)
Lead Sponsor:
Merck Sharp & Dohme LLC
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE1
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 whet...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00954538
Start Date
August 1 2009
End Date
May 1 2011
Last Update
November 3 2015
Active Locations (0)
Enter a location and click search to find clinical trials sorted by distance.
No Results Found
We couldn’t find results for the location/zipcode entered or within the selected range. Please check your input or adjust your search.