Status:
COMPLETED
Exploratory and Safety Study of [F-18]W372
Lead Sponsor:
Siemens Molecular Imaging
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
55+ years
Phase:
EARLY_PHASE1
Brief 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 an...
Detailed Description
\[F-18\]W372 is being developed as a diagnostic radiopharmaceutical for PET imaging of the human brain. SMI is seeking to determine if \[F-18\]W372 might be useful as a noninvasive assessment tool in...
Eligibility Criteria
Inclusion
- Low Probability Subjects for AD:
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of communicating with study personnel
- For inclusion into Group 1, in the opinion of the Investigator, the subject has a low probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE ≥ 28)
- High Probability Subjects for AD:
- Subject has reached his or her 55th birthday at the time of the investigational product administration, and is male or female of any race / ethnicity
- Subject or subject's legally acceptable representative provides written informed consent
- Subject is capable of communicating with study personnel
- For inclusion into Group 2, in the opinion of the Investigator, the subject has a high probability of being currently positive for AD that is determined by a Mini Mental State Examination (MMSE \< 24)
Exclusion
- For All Subjects:
- Subject is not capable of complying with study procedures
- Female subject is pregnant
- Exclude non-post menopausal females as defined by being one year without menses, or cannot be pregnant from her past medical history
- Subject has prior history of stroke or other condition of the head or neck that, in the Investigator's opinion, might affect circulation to the head or image interpretation
- Subject has a medical condition associated with elevated amyloid levels, such as amyloid angiopathy, familial amyloidosis, chronic kidney dialysis, Down's syndrome
- Subject has a history of significant cerebrovascular disease
- Subject has a significant hepatic or renal disease as defined by previous medical history or abnormal hepatic and renal functions determined by lab results not within the following ranges, or, in the opinion of the Investigator, the values are not acceptable for the subject to be included:
- Total bilirubin within 2x institutional upper limits of normal
- AST (SGOT)/ALT (SGPT) ≤ 2.5 x institutional upper limits of normal
- Serum creatinine ≤ 2x institutional upper limits of normal
- BUN within 2x institutional upper limits of normal
- Subject has previously received \[F-18\]W372 at any time
- Subject has been involved in an investigative, radioactive research procedure within the past 14 days
- Subject has any other condition or personal circumstance that, in the judgment of the Investigator, might interfere with the collection of complete data or data quality
- Subject has a history in the last five years of significant prescription or nonprescription drug or alcohol abuse, including but not limited to marijuana, cocaine, heroin or derivatives.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00954369
Start Date
August 1 2009
End Date
February 1 2010
Last Update
August 22 2012
Active Locations (1)
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1
University of California, Irvine
Irvine, California, United States, 92697-5020