Phase 1
Completed N=3
Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)
Source: ClinicalTrials.gov NCT00954538 ↗Enrolled (actual)
3
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcomePrimary: Number of Participants With an Adverse Event (AE) — 8 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With an Adverse Event (AE) |
8 | — |
| PRIMARY Number of Participants Who Discontinued Study Due to an AE |
— | — |
| PRIMARY Effective Dose of [18F]MK-3328 |
18.2 | — |
| PRIMARY Organ Effective Dose of [18F]MK-3328 |
0.0404; 0.0635; 0.307; 0; 2.57; 0.149 | — |
| PRIMARY Mean Brain Cortical [18F]MK-3328 Standard Uptake Value Ratio (SUVR) in AD Participants and HE Participants |
1.75; 1.34 | <0.01 sig |
| PRIMARY Least Squares (LS) Mean [18F]MK-3328 SUVR in Brain Posterior Cingulate Gyrus in AD Participants and HE Participants |
1.47; 1.35 | — |
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
Data sourced from ClinicalTrials.gov (NCT00954538). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.