PET Imaging of Brain Amyloid Using [11C]MeS-IMPY

Alzheimer's disease is associated with accumulation in the brain of a protein called amyloid. The purpose of this study is to test the ability of a research drug to measure amyloid in brain using positron emission tomography (PET) and a research drug called [11C]MeS-IMPY.

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Key information

Conditions

Alzheimer's Disease Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Healthy Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

About this study

Alzheimer's disease (AD) is characterized pathologically by the presence of beta-amyloid plaques in brain. A substantial body of research indicates that the presence of increased beta -amyloid peptide is neurotoxic, and may initiate further pathology observed in AD including neurofibrillary tangles, synaptic loss and dysfunction, and neurodegeneration. There are multiple binding sites available on beta-amyloid plaques. Three clearly identified sites are Congo-red type, Thioflavin-T type, and FDDNP type. Radioligands currently under development using positron emission tomography (PET) for studying beta-amyloid in clinical research or drug development are based on Thioflavin-T site, such as [11C]PIB and [11C]SB-13. Though variously effective, these radioligands have one or more drawbacks with respect to measuring relative regional beta-amyloid densities. Therefore, we have recently developed [11C]MeS-IMPY as an alternative radioligand for imaging beta-amyloid, which will allow a more accurate quantification of amyloid plaques in AD brain. In the current protocol, we wish to evaluate [11C]MeS-IMPY in both healthy subjects and AD patients to determine the kinetics of brain imaging beta-amyloid plaques in AD patients.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

INCLUSION CRITERIA:

Healthy control subjects aged 18-90 years and AD patients aged 50-90, with history/physical exam, ECG, and laboratory tests.

Informed Consent.

AD Patients: Mini-Mental State Examination (score greater than or equal to 10).

AD Patients: Meet NINCDS-ADRDA criteria for probable AD.

Exclusion criteria

Current or prior history of any alcohol or drug abuse.
Severe systemic disease based on history and physical exam.
Positive result on urine screen for illicit drugs.
Laboratory tests with clinically significant abnormalities.
Prior participation in other research protocols or clinical care in the last year such that radiation exposure would exceed the annual limits.
Pregnancy or breast feeding.
Claustrophobia.
Presence of ferromagnetic metal in the body or heart pacemaker.
History of brain disease other than Alzheimer's disease.
Unable to lay on one's back for the PET/MRI scan.

Treatment and study plan

[11C]MeS-IMPY

Drug

Sponsors and collaborators

Lead sponsor

National Institute of Mental Health (NIMH)

Nih

Registry information

Important dates

Study start: 2006
Primary completion: 2008
First posted: Dec 5, 2006
Registry last updated: Jul 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed