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Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001) | Clinical Trials | Clareo Health

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Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)

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

NCT00954538•Merck Sharp & Dohme LLC

View on ClinicalTrials.gov

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

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Key Dates

Start Date

August 1, 2009

Primary Completion Date

May 1, 2011

Completion Date

May 1, 2011

Last Updated

November 3, 2015

Enrollment

ACTUAL participants

Conditions

Alzheimer's Disease

Interventions

[18F]MK-3328

DRUG

ACP-204 in Adults With Alzheimer's Disease Psychosis

NCT06159673

Alzheimer's Disease Psychosis

View study

RECRUITING

Lombard Cohort of Brain Health Services

NCT07457138

Subjective Cognitive Decline (SCD)Functional Cognitive Disorder+2 more

View study

RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 3, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety, Radiation Dosimetry, Biokinetics, and Effectiveness of [18F]MK3328 (MK-3328-001)

Inclusion Criteria

Exclusion Criteria

ACP-204 in Adults With Alzheimer's Disease Psychosis

Lombard Cohort of Brain Health Services

A Clinical Study of MK-2214 in People With Early Alzheimer's Disease (MK-2214-004)

A Study to Evaluate ALN-5288 in Patients With Alzheimer's Disease

Evaluate the Use of [18F]-APN-1607 PET in Subjects With AD-related Cognitive Impairment and Subjects With Normal Cognitive Function

Development of a Database to Investigate Digital and Blood-Based Biomarkers and Their Relationship to Tau and Amyloid PET Imaging in Older Participants Who Are Cognitively Normal (CN), Have Mild Cognitive Impairment (MCI), or Have Mild-to-Moderate AD Dementia