Exploratory and Safety Study of [F-18]W372

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00954369
• Date of registration: 05/08/2009
• Primary sponsor: Siemens Molecular Imaging
• Public title: Exploratory and Safety Study of [F-18]W372
• Scientific title: A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372
• Date of first enrolment: August 2009
• Target sample size: 24
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00954369
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Lydia Min-Ying Su, PhD
• Affiliation: University of California, Irvine

Key inclusion & exclusion 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.



Age minimum: 55 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: [F-18]W372

Primary Outcome(s)

Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug. [Time Frame: Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit]

Secondary ID(s)

W372000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors