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Exploratory and Safety Study of [F-18]W372

NCT00954369 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2012-08-22

No results posted yet for this study

Summary

PHASE: Phase 0, Exploratory Study

OBJECTIVES: To collect drug safety, bio-distribution and dosimetry data, to begin collection of PET/CT imaging data, to acquire experience to improve study design and the conduct of future studies.

DESIGN: Exploratory, open label, non-randomized, multi-center study.

DURATION: Three visits - one screening, one imaging, and one follow-up visit at 24 hours post-dose

PROCEDURES: Informed consent, collection of demographic information and medical history, administration of mental status exam, physical examination, vital signs, 12-lead ECGs, routine blood tests to assess major organ functions, complete blood counts and clinical chemistries for safety, dosing with \[F-18\]W372, PET imaging scans of brain (in sixteen subjects), whole body PET imaging and urine collections for dosimetry evaluation (in four subjects only), observation and interviews following imaging to collect adverse events.

SUBJECTS: Twenty (20) subjects ≥ 55 years old:

Group 1 will consist of 10 subjects who have a low probability of being currently positive for Alzheimer's Disease (AD) as defined by the protocol criteria (MMSE ≥ 28). Four of the 10 subjects will undergo whole body PET imaging for dosimetry evaluations, and 6 of the 10 subjects will undergo PET imaging of the brain only.

Group 2 will consist of 10 subjects who have a high probability of currently being positive for AD as defined by the protocol criteria (MMSE \< 24); these 10 subjects will undergo PET imaging of the brain only.

Conditions

Interventions

DRUG

[F-18]W372

The individual doses of \[F-18\]W372 contain a maximum of 20 mCi for normal volunteers and 10 mCi for high probability AD subjects. The single IP dose is administered to the study subject immediately prior to the start of PET imaging.

Sponsors & Collaborators

  • Siemens Molecular Imaging

    lead INDUSTRY

Principal Investigators

  • Lydia Min-Ying Su, PhD · University of California, Irvine

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-02-28
Completion
2010-02-28

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00954369 on ClinicalTrials.gov