Exploratory and Safety Study of [F-18]W372

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Siemens Molecular Imaging

Criteria

Inclusion Criteria:

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 Criteria:

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.