Exploratory and Safety Study of [F-18]W372

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Siemens Molecular Imaging
ClinicalTrials.gov Identifier:
NCT00954369
First received: August 5, 2009
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: [F-18]W372
Phase 0

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Phase 0, Open Label, Non-randomized, Multi-center, Exploratory and Safety Study of [F-18]W372

Resource links provided by NLM:


Further study details as provided by Siemens Molecular Imaging:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Enrollment: 24
Study Start Date: August 2009
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [F-18]W372
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

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.

Other Names:
  • [F-18] W372
  • W372

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00954369

Locations
United States, California
University of California, Irvine
Irvine, California, United States, 92697-5020
Sponsors and Collaborators
Siemens Molecular Imaging
Investigators
Principal Investigator: Lydia Min-Ying Su, PhD University of California, Irvine
  More Information

No publications provided

Responsible Party: Siemens Molecular Imaging
ClinicalTrials.gov Identifier: NCT00954369     History of Changes
Other Study ID Numbers: W372000
Study First Received: August 5, 2009
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Siemens Molecular Imaging:
Alzheimer's disease
AD
W372
W372000
[F-18]W372
exploratory
imaging

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 23, 2014