Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00857415
• Date of registration: 05/03/2009
• Primary sponsor: Avid Radiopharmaceuticals
• Public title: Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain
• Scientific title: A Phase III Study of the Correlation Between Florbetapir F 18 (18F-AV-45) PET Imaging and Amyloid Pathology
• Date of first enrolment: December 2008
• Target sample size: 226
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00857415
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Countries of recruitment

United States

Contacts

• Name: Chief Medical Officer
• Affiliation: Avid Radiopharmaceuticals

Key inclusion & exclusion criteria

Inclusion Criteria (autopsy cohort):

- Have a projected life expectancy of = 6 months as determined by the principal
investigator (e.g. terminal medical condition) or are already enrolled in a
longitudinal study of aging with an autopsy component;

- Can tolerate a 10 minute PET scan; and

- Give informed consent for study procedures and brain donation consistent with the
legal requirements of the State in which they are enrolled and the State in which
they die.

Inclusion Criteria (specificity cohort):

- Cognitively and neurologically healthy males and females 18 to 40 years of age;

- Who had no known risk factors for AD, including:

- Known genetic risk factors for AD, including an ApoE e4 allele (note: ApoE genotype
was determined after enrollment and was not disclosed to healthy control subjects).
Scans from subjects carrying an ApoE e4 allele were not included in the primary
specificity analysis, but were included in an exploratory analysis;

- First degree relative with a known progressive dementing disorder;

- History of cognitive decline;

- History of neurologic, neurodegenerative, or psychiatric disease;

- History of head trauma; or

- Evidence of brain abnormality on a MRI scan;

- Who performed in an age-appropriate normal range on the Wechsler Logical Memory I &
II, story A;

- Who could tolerate a 10-minute PET scan; and

- Who provided informed consent before any study procedures were performed.

Exclusion Criteria:

- Have primary brain tumor, known metastases to the brain, central nervous system (CNS)
lymphoma;

- Have any major, focal structural loss of brain matter;

- Are aggressively being treated with life sustaining measures (e.g. currently on
respirator; receiving high dose chemotherapy);

- Have a clinically significant infectious disease, including Acquired Immune
Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous
positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);

- Are receiving any investigational medications, or have participated in a trial with
investigational medications within the last 30 days;

- Have ever participated in an experimental study with an amyloid targeting agent (e.g.
anti-amyloid immunotherapy, secretase inhibitor);

- Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to
the study imaging session; or

- Are females of childbearing potential who are pregnant or not using adequate
contraception.



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Disease

Intervention(s)

Drug: florbetapir F 18

Primary Outcome(s)

Correlation of Florbetapir-PET Image and Amyloid Plaque Density [Time Frame: at autopsy up to 12 months post-scan]

Specificity Analysis [Time Frame: 50-60 min after injection]

Secondary Outcome(s)

Regional Correlation Analysis [Time Frame: at autopsy up to 12 months post-scan]

Secondary ID(s)

18F-AV-45-A07

Source(s) of Monetary Support

Please refer to primary and secondary sponsors