Exploratory and Safety Study of [F-18]W372

NCT00954369 | Completed Early Phase 1

• 1 other identifier: W372000
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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 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

Alzheimer's Disease

Keywords

Alzheimer's disease; AD; W372; W372000; [F-18]W372; exploratory; imaging

Outcome Measures

Primary Outcomes (1)

• Safety will be the outcome demonstrated in this clinical trial through analyses of adverse events in subjects who receive study drug.

  Three (3) study visits, including the initial screening visit, the imaging visit, and the 24 hour follow-up visit

Study Arms (1)

[F-18]W372

EXPERIMENTAL

Approximately twenty (20) adult subjects including ten (10) healthy volunteers and ten (10) high probability AD subjects, as defined by protocol criteria

Drug: [F-18]W372

Interventions

[F-18]W372 DRUG

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.

Also known as: [F-18] W372, W372

[F-18]W372

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Siemens Molecular Imaging: lead

Study Sites (1)

University of California, Irvine

Irvine, California, 92697-5020, United States

Location

MeSH Terms

Conditions

Alzheimer Disease

Condition Hierarchy (Ancestors)

Dementia; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Lydia Min-Ying Su, PhD

  University of California, Irvine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2009
• First Posted: August 7, 2009
• Study Start: August 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: February 1, 2010
• Last Updated: August 22, 2012

Record last verified: 2012-08

Locations

US (1)